Low Back PainPhase 4DanteNCT05170841
Study Evaluating Dexketoprofen Trometamol/Tramadol Hydrochloride Analgesic Efficacy in Acute Low Back Pain
A Phase 4 study testing Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg and Tramadol Hydrochloride 100 mg in people with Low Back Pain, run by Menarini International Operations Luxembourg SA at 1 site in Italy.
Trial summary
A randomized, double-blind, study to evaluate the analgesic efficacy and safety of Dexketoprofen trometamol and Tramadol hydrochloride combination versus placebo on moderate to severe acute pain in patients with acute low back pain. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg and Tramadol Hydrochloride 100 mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 538 participants
- Where
- 1 siteItaly
- Study dates
- 17 Sep 2020to 4 May 2022
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Properly executed written informed consent.
- Male or female patients aged 18 years to 65 years.
- Patients with acute low back reporting pain of at least moderate intensity at Screening (NRS score ≥ 5). The onset of the current acute low back pain episode is within 48 hours prior to Screening.
- Patients with or without radiculopathy will be included, excluding those with neurological signs, according to the Quebec Task Force classification.
- Naïve patients to any low back pain or patients with previous history of low back pain experiencing a new episode, preceded by a period of at least 2 months without any low back pain prior to Screening.
- Patients free from analgesic (as per exclusion criterion 14) due to previously administered pain killer (immediate or slow release formulations), according to physician's judgment.
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- Females participating in the study must be either:
- Females of non childbearing potential, defined as any woman who had undergone surgical sterilization (documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) or is more than 2 years post menopausal (defined as no menses for 12 months);
- Females of childbearing potential (following menarche until menopause unless permanently sterile) provided that they have a negative pregnancy test at Screening and are routinely using an effective method of birth control resulting in a low failure rate (ie, combined hormonal contraception, intrauterine device, condoms in combination with a spermicidal cream, male partner sterilization (vasectomy), bilateral tubal occlusion or total sexual abstinence) during the study treatment.
- Mentally competent and able to understand and give written informed consent prior to Screening.
- Compliant to undergo all visits and procedures scheduled in the Study.
Who cannot join
- Patients who are judged by the Investigator not to be suitable candidates for the study treatments and the Rescue Medication (RM) based on their medical history, physical examination, Concomitant Medication (CM) and concurrent systemic diseases.
- Clinically significant abnormalities in the vital signs as per Investigator's judgment.
- Patients with acute low back pain and radiation to limb with presence of neurologic signs (focal weakness, asymmetry of reflexes, sensory loss in a dermatome, or loss of bowel, bladder, or sexual function) according to Quebec Task Force Classification.
- History of hypersensitivity to the study treatments, RM or to any other nonsteroidal anti-inflammatory drugs (NSAIDs), or opioids.
- Known photoallergic or phototoxic reactions during treatment with ketoprofen or fibrates.
- History of peptic ulcer, gastrointestinal disorders when taking NSAIDs, gastrointestinal bleeding, or other active bleeding.
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- History of allergy (eg, precipitate attacks of asthma, bronchospasm, acute rhinitis, or cause nasal polyps, urticaria or angioneurotic oedema) to the study treatments, RM or to any other NSAIDs, or opioids.
- Anamnestic mild to severe renal dysfunction, mild to severe hepatic dysfunction, as per Investigator's judgment.
- Patients with chronic dyspepsia.
- Patients with severe heart failure [Class III and Class IV of New York Heart Association (NYHA) Classification].
- History of hemorrhagic diathesis and other coagulation disorders.
- History of or current epilepsy or convulsions.
- Patients with Crohn's disease or ulcerative colitis.
- Patients receiving monoamine oxidase (MAO) inhibitors (a minimum of 14 days of washout must elapse prior to the Screening).
- Treatment with topical preparations/medications within 4 hours prior to Screening, anesthetics and muscle relaxants within 8 hours prior to Screening, short-acting analgesics (eg, paracetamol) within 4 hours prior to Screening, other analgesics within 5 half-lives prior to Screening or use of an opioid within the 14 days preceding Screening.
- Treatment with high doses of salicylates (≥3 g/day), anticoagulants, thrombolytic and antiplatelet agents, heparins, corticosteroids (except inhalers and topical agents), lithium methotrexate, used at high doses of 15 mg/week or more, hydantoins (including phenytoin) and sulphonamides, antiepileptics, antipsychotics, serotonin reuptake inhibitors and tricyclic antidepressants, and analgesics within 48 hours or 5 half-lives (whichever is the longer) prior to Screening.
- Patients using sedatives (eg, benzodiazepines) and hypnotic agents within 8 hours before Screening.
- Any chronic or acute painful condition other than the study indication that may interfere with the assessment of the efficacy of the study treatment.
- Any non-pharmacological interventional therapy for low back pain (physical therapy, acupuncture, massage etc.) one month before Screening.
- Patients with litigation related to work.
- Patients with severe dehydration (caused by vomiting, diarrhea, or insufficient fluid intake) within one month prior to Screening.
- Severe respiratory depression according to physician's judgment.
- Participation in other clinical studies in the previous 4 weeks.
- History of drug or alcohol abuse. For the purpose of the study, alcohol abuse is defined as regularly intake of more than 4 units of alcohol per day (1 unit corresponds approximately to 125 ml wine, 200 ml beer, 25 ml spirit).
- History of any illness or condition that, in the opinion of the Investigator might pose a risk to the patient or confound the efficacy and safety results of the study.
- Pregnant and breastfeeding women: a pregnancy test will be performed on all women of childbearing potential at Screening.
- Patients presenting any of the contraindications reported for dexketoprofen/tramadol, tramadol or paracetamol (according to the SmPC).
- Known or suspected serious spinal pathology (eg, metastatic, inflammatory or infective diseases of the spine, cauda equine syndrome, trauma, spinal fracture).
- Spinal surgery within the preceding 6 months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Randomized, Double-blind, Placebo-controlled, Parallel Arm Group Study Evaluating Analgesic Efficacy and Safety of Dexketoprofen Trometamol and Tramadol Hydrochloride on Moderate to Severe Acute Pain in Patients With Acute Low Back Pain
A randomized, double-blind, study to evaluate the analgesic efficacy and safety of Dexketoprofen trometamol and Tramadol hydrochloride combination versus placebo on moderate to severe acute pain in patients with acute low back pain.
Read the detailed description
This is a multicenter, randomized, double-blind, double-dummy, parallel group, placebo-controlled study encompassing 2 study phases: a single-dose phase (first 8 hours) and a multiple-dose phase starting after the single-dose phase (from 8h until day 5).
Study population will be of male or female patients aged 18 years to 65 years with acute low back pain of moderate to severe intensity, whose onset of the current acute low back pain episode is within 48 hours prior to Screening. Patients with or without radiculopathy will be included, excluding those with neurological signs, according to the Quebec Task Force classification. Patients experiencing a new episode of low back pain will be eligible only if preceded by a period of at least 2 months without any low back pain. Patients should be free from analgesic due to previously administered pain killer (immediate or slow release formulations), according to exclusion criteria.
Approximately 612 patients will be screened to achieve 510 patients randomly assigned to study treatment.
In the single-dose phase patients will receive a single-dose treatment, consisting of 1 film-coated tablet and 2 capsules which have to be orally administered together at the same time (Day 1). The multiple-dose phase will begin 8 hours after the first dose. The patients assigned to Dexketoprofen/Tramadol fixed combination or Tramadol 100 milligram (mg) during the single-dose phase will continue to receive the same treatment during the multiple-dose phase; however, the patients assigned to receive placebo during the single-dose phase will either receive Dexketoprofen/Tramadol fixed combination or Tramadol 100 mg during the multiple-dose phase.
- Conditions
- Low Back Pain
- Being tested
- Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg, Tramadol Hydrochloride 100 mg, Placebo
- Medical subject headings
- Low Back Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mgDrug
Also called Skudexa
Administered as one single tablet to be taken every 8 hours
Tramadol Hydrochloride 100 mgDrug
Also called Tramadol
Administered as two capsules with 50 mg each to be taken every 8 hours
PlaceboDrug
Administered as one tablet if matching Dexketoprofen Trometamol 25 mg and Tramadol Hydrochloride 75 mg or two capsules if matching Tramadol Hydrochloride 100 mg
| Study group | Role | What they receive |
|---|---|---|
| Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg treatment | Active comparator | Two phase intervention. Single Dose Phase (time 0 - time 8h) and Multiple Dose phase (time 8h - Day 5) In this arm patients will receive during each phase film coated tablets (administered as one tablet) Receives: Drug: Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg |
| Tramadol Hydrochloride 100 mg treatment | Active comparator | Two phase intervention. Single Dose Phase (time 0 - time 8h) and Multiple Dose Phase (time 8h - Day 5) In this arm patients will receive during each phase (administered as 2 capsules of Tramadol 50 mg) Receives: Drug: Tramadol Hydrochloride 100 mg |
| Placebo and Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg treatment | Placebo comparator | Two phase intervention. Single dose phase (time 0 - time 8h) and Multiple Dose Phase (time 8h - Day 5).
SINGLE DOSE PHASE: Placebo film-coated tablets matching Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg MULTIPLE DOSE PHASE: Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg film coated tablets (administered as one tablet) Receives: Drug: Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg; Drug: Placebo |
| Placebo and Tramadol Hydrochloride 100 mg | Placebo comparator | Two phase intervention. Single Dose Phase (time 0 - time 8h) and Multiple Dose Phase (time 8h - Day 5).
SINGLE DOSE PHASE: Placebo capsules matching active comparator (administered as 2 capsules of Tramadol 50 mg) MULTIPLE DOSE PHASE: Tramadol Hydrochloride 100 mg (administered as 2 capsules of Tramadol 50 mg) Receives: Drug: Tramadol Hydrochloride 100 mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to First Achieve a Numeric Rating Scale-Pain Intensity Score <4 or a Pain Intensity Reduction of ≥30% From Drug Intake Till 8 Hours After the First Dose
Time to first achieve a Numeric Rating Scale-Pain Intensity (NRS-PI) score of <4 or a pain intensity reduction ≥30% from drug intake till 8 hours after the first dose.
Numeric Rate Scale-Pain Intensity is a Patients rated Pain Intensity scale using an 11-point Numeric Rate Scale (0 no pain; 10 worst pain).
Measured: 8 hours from first intake (referring to first 8 hours of Single Dose Phase)
Secondary outcomes (25)
Total Pain Relief (TOTPAR) at 4h After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol
TOTPAR was calculated as the time-weighted sum of the PAR- (VRS) scores. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at prespecified time point points in the single and the multiple-dose phases of the study. TOTPAR minimum and maximum values were 0 to 16 for Dexketoprofen/Tramadol group and 0 to 14 for Tramadol group. TOTPAR scale ranges from 0 with no upper limit.
Measured: From t=o to T=4 hours
Total Pain Relief (TOTPAR) at 6h After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol
TOTPAR was calculated as the time-weighted sum of the PAR-VRS scores. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at prespecified time point points in the single and the multiple-dose phases of the study. TOTPAR minimum and maximum values were 0 to 24 for Dexketoprofen/Tramadol group and 0 to 19 for Tramadol group. TOTPAR scale ranges from 0 with no upper limit.
Measured: T=0 to T=6h
Total Pain Relief (TOTPAR) at 8h After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol
TOTPAR was calculated as the time-weighted sum of the PAR-VRS scores. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at prespecified time point points in the single and the multiple-dose phases of the study. TOTPAR minimum and maximum values were 0 to 31 for Dexketoprofen/Tramadol group and 0 to 26 for Tramadol group. TOTPAR scale ranges from 0 with no upper limit.
Measured: From T=0 to T=8h
Total Pain Relief (TOTPAR) at 6h After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Placebo
TOTPAR was calculated as the time-weighted sum of the PAR-VRS scores. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at prespecified time point points in the single and the multiple-dose phases of the study. TOTPAR minimum and maximum values were 0 to 24 for Dexketoprofen/Tramadol group and 0 to 23 for Placebo group. TOTPAR scale ranges from 0 with no upper limit.
Measured: From T=0 to T=6h
Total Pain Relief (TOTPAR) at 8h After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Placebo
TOTPAR was calculated as the time-weighted sum of the PAR-VRS scores. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at prespecified time point points in the single and the multiple-dose phases of the study. TOTPAR minimum and maximum values were 0 to 31 for Dexketoprofen/Tramadol group and 0 to 27 for Placebo group. TOTPAR scale ranges from 0 with no upper limit.
Measured: Form T=0 to T=8h
Percentage of Maximum TOTPAR (%Max TOTPAR) at 4 Hours After the First Dose- Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol
Max TOTPAR was calculated as the theoretical maximum time-weighted sum of the PAR values for each patient. The maximum possible TOTPAR was the value of TOTPAR that would have been obtained if the patient had a complete pain relief for that observation period. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), and percentage of maximum TOTPAR (%max TOTPAR), were calculated at prespecified time points in the single and the multiple-dose phases of the study. Percentage of maximum TOTPAR minimum and maximum values were 0 to 97 and 0 to 84 respectively for Dexketoprofen/Tramadol and Tramadol group. %max TOTPAR scale ranges from 0 to 100.
Measured: Form T=0 to T=4h
Percentage of Maximum TOTPAR (%Max TOTPAR) at 6 Hours After the First Dose- Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol
Max TOTPAR was calculated as the theoretical maximum time-weighted sum of the PAR values for each patient. The maximum possible TOTPAR was the value of TOTPAR that would have been obtained if the patient had a complete pain relief for that observation period. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), and percentage of maximum TOTPAR (%max TOTPAR) were calculated at prespecified time point points in the single and the multiple-dose phases of the study. Percentage of maximum TOTPAR minimum and maximum values were 0 to 98 for Dexketoprofen/Tramadol group and 0 to 77 for Tramadol group. %max TOTPAR scale ranges from 0 to 100.
Measured: Form T=0 to T=6h
Percentage of Maximum TOTPAR (%Max TOTPAR) at 8 Hours After the First Dose- Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol
The max TOTPAR was calculated as the theoretical maximum time-weighted sum of the PAR values for each patient. The maximum possible TOTPAR was the value of TOTPAR that would have been obtained if the patient had a complete pain relief for that observation period. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), and percentage of maximum TOTPAR (%max TOTPAR) were calculated at prespecified time point points in the single and the multiple-dose phases of the study. Percentage of maximum TOTPAR minimum and maximum values were 0 to 98 for Dexketoprofen/Tramadol group and 0 to 83 for Tramadol group. %max TOTPAR scale ranges from 0 to 100.
Measured: Form T=0 to T=8h
Percentage of Maximum TOTPAR (%Max TOTPAR) at 6 Hours After the First Dose- Single Dose Phase - Dexketoprofen/Tramadol vs Placebo
The max TOTPAR was calculated as the theoretical maximum time-weighted sum of the PAR values for each patient. The maximum possible TOTPAR was the value of TOTPAR that would have been obtained if the patient had a complete pain relief for that observation period. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), and percentage of maximum TOTPAR (%max TOTPAR) were calculated at prespecified time point points in the single and the multiple-dose phases of the study. Percentage of maximum TOTPAR minimum and maximum values were 0 to 98 for Dexketoprofen/Tramadol group and 0 to 94 for Placebo group. %max TOTPAR scale ranges from 0 to 100.
Measured: Form T=0 to T=6h
Percentage of Maximum TOTPAR (%Max TOTPAR) at 8 Hours After the First Dose- Single Dose Phase - Dexketoprofen/Tramadol vs Placebo
The max TOTPAR was calculated as the theoretical maximum time-weighted sum of the PAR values for each patient. The maximum possible TOTPAR was the value of TOTPAR that would have been obtained if the patient had a complete pain relief for that observation period. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), and percentage of maximum TOTPAR (%max TOTPAR) were calculated at prespecified time point points in the single and the multiple-dose phases of the study. Percentage of maximum TOTPAR minimum and maximum values were 0 to 98 for Dexketoprofen/Tramadol group and 0 to 83 for Placebo group. %max TOTPAR scale ranges from 0 to 100.
Measured: Form T=0 to T=8h
Percentage of Patients Achieving at Least 50% of Maximum TOTPAR at 4 Hours After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol
Measured: Form T=0 to T=4h
Percentage of Patients Achieving at Least 50% of Maximum TOTPAR at 6 Hours After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol
Measured: Form T=0 to T=6h
Percentage of Patients Achieving at Least 50% of Maximum TOTPAR at 8 Hours After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol
Measured: Form T=0 to T=8h
Percentage of Patients Achieving at Least 50% of Maximum TOTPAR at 4 Hours After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Placebo
TOTPAR was calculated as the time-weighted sum of the PAR-VRS scores. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at pre-specified time point points in the single and the multiple-dose phases of the study.
Measured: Form T=0 to T=4h
Percentage of Patients Achieving at Least 50% of Maximum TOTPAR at 6 Hours After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Placebo
TOTPAR was calculated as the time-weighted sum of the PAR-VRS scores. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at pre specified time point points in the single and the multiple-dose phases of the study.
Measured: Form T=0 to T=6h
Percentage of Patients Achieving at Least 50% of Maximum TOTPAR at 8 Hours After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Placebo
TOTPAR was calculated as the time-weighted sum of the PAR-VRS scores. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at pre specified time point points in the single and the multiple-dose phases of the study.
Measured: Form T=0 to T=8h
Total Pain Relief (TOTPAR) at 24h After the First Dose - Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol
TOTPAR was calculated as the time-weighted sum of the PAR-VRS scores. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at prespecified time point points in the single and the multiple-dose phases of the study. TOTPAR minimum and maximum values were 0 to 96 for Dexketoprofen/Tramadol group and 0 to 90 for Tramadol group. TOTPAR scale ranges from 0 with no upper limit.
Measured: Form T=0 to T=24h
Total Pain Relief (TOTPAR) at 48h After the First Dose - Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol
TOTPAR was calculated as the time-weighted sum of the PAR-VRS scores. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at prespecified time point points in the single and the multiple-dose phases of the study. TOTPAR minimum and maximum values were 0 to 192 for Dexketoprofen/Tramadol group and 0 to 184 for Tramadol group. TOTPAR scale ranges from 0 with no upper limit.
Measured: Form T=0 to T=48h
Total Pain Relief (TOTPAR) at 72h After the First Dose - Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol
TOTPAR was calculated as the time-weighted sum of the PAR-VRS scores. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at prespecified time point points in the single and the multiple-dose phases of the study. TOTPAR minimum and maximum values were 0 to 288 for Dexketoprofen/Tramadol group and 0 to 280 for Tramadol group. TOTPAR scale ranges from 0 with no upper limit.
Measured: Form T=0 to T=72h
Percentage of Maximum TOTPAR (%Max TOTPAR) at 24 Hours After the First Dose- Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol
The max TOTPAR was calculated as the theoretical maximum time-weighted sum of the PAR values for each patient. The maximum possible TOTPAR was the value of TOTPAR that would have been obtained if the patient had a complete pain relief for that observation period. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), and percentage of maximum TOTPAR (%max TOTPAR) were calculated at prespecified time point points in the single and the multiple-dose phases of the study. Percentage of maximum TOTPAR minimum and maximum values were 0 to 100 for Dexketoprofen/Tramadol group and 0 to 94 for Tramadol group. %max TOTPAR scale ranges from 0 to 100.
Measured: Form T=0 to T=24h
Percentage of Maximum TOTPAR (%Max TOTPAR) at 48 Hours After the First Dose- Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol
The max TOTPAR was calculated as the theoretical maximum time-weighted sum of the PAR values for each patient. The maximum possible TOTPAR was the value of TOTPAR that would have been obtained if the patient had a complete pain relief for that observation period. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), and percentage of maximum TOTPAR (%max TOTPAR) were calculated at prespecified time point points in the single and the multiple-dose phases of the study. Percentage of maximum TOTPAR minimum and maximum values were 0 to 100 for Dexketoprofen/Tramadol group and 0 to 96 for Tramadol group. %max TOTPAR scale ranges from 0 to 100.
Measured: Form T=0 to T=48h
Percentage of Maximum TOTPAR (%Max TOTPAR) at 72 Hours After the First Dose- Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol
The max TOTPAR was calculated as the theoretical maximum time-weighted sum of the PAR values for each patient. The maximum possible TOTPAR was the value of TOTPAR that would have been obtained if the patient had a complete pain relief for that observation period. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), and percentage of maximum TOTPAR (%max TOTPAR) were calculated at prespecified time point points in the single and the multiple-dose phases of the study. Percentage of maximum TOTPAR minimum and maximum values were 0 to 100 for Dexketoprofen/Tramadol group and 0 to 97 for Tramadol group. %max TOTPAR scale ranges from 0 to 100.
Measured: Form T=0 to T=72h
Percentage of Maximum TOTPAR (%Max TOTPAR) at 96 Hours After the First Dose- Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol
The max TOTPAR was calculated as the theoretical maximum time-weighted sum of the PAR values for each patient. The maximum possible TOTPAR was the value of TOTPAR that would have been obtained if the patient had a complete pain relief for that observation period. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), and percentage of maximum TOTPAR (%max TOTPAR) were calculated at prespecified time point points in the single and the multiple-dose phases of the study. Percentage of maximum TOTPAR minimum and maximum values were 0 to 100 for Dexketoprofen/Tramadol group and 0 to 98 for Tramadol group. %max TOTPAR scale ranges from 0 to 100.
Measured: Form T=0 to T=96h
Percentage of Patients Achieving at Least 50% of Maximum TOTPAR at 48 Hours After the First Dose - Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol
TOTPAR was calculated as the time-weighted sum of the PAR-VRS scores. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some (meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR), percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at pre-specified time point points in the single and the multiple-dose phases of the study.
Measured: Form T=0 to T=48h
Percentage of Patients Achieving at Least 50% of Maximum TOTPAR at 72 Hours After the First Dose - Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol
The max TOTPAR was calculated as the theoretical maximum time-weighted sum of the PAR values for each patient. The maximum possible TOTPAR was the value of TOTPAR that would have been obtained if the patient had a complete pain relief for that observation period. The Verbal Rating Scale (VRS) is a 5-point scale to assess the pain relief. The patients were asked to answer the question 'How do you rate your pain relief?' where 0 = 'no relief', 1 = 'a little (perceptible) relief', 2 = 'some(meaningful) relief', 3 = 'lot of relief', 4 = 'complete relief'. Based on VRS, pain relief (PAR) scores, total pain relief (TOTPAR),percentage of maximum TOTPAR (%max TOTPAR), and percentage of patients achieving at least 50% of maximum TOTPAR were calculated at pre specified time point points in the single and the multiple-dose phases of the study.
Measured: Form T=0 to T=72h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Dec 2021
- Study start17 Sep 2020
- Primary completion4 May 2022
- Study completion4 May 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Low Back PainStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 2 study phases: a single-dose phase (first 8 hours) and a multiple-dose phase starting after the single-dose phase (from 8h until Day 5).In the single-dose phase the patients will receive a single dose treatment, consisting of 1 film-coated tablet and 2 capsules which must be orally administered together at the same time (Day 1). The multiple-dose phase will begin 8 hours after the first dose. The patients assigned to Dexketoprofen/Tramadol fixed combination or Tramadol 100 mg during the single-dose phase will continue to receive the same treatment during the multiple-dose phase; however, the patients assigned to receive placebo during the single-dose phase will either receive Dexketoprofen/Tramadol fixed combination or Tramadol 100 mg during the multiple-dose phase.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 538 participants (actual)
Sponsor and investigators
- Lead sponsor
- Menarini International Operations Luxembourg SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Giustino Varrassi, Professor, Principal investigator, University of L'Aquila
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05170841
- Sponsor's protocol ID
- MEIN/18/DEX-LBP/001
- Other IDs
- 2019-003656-37, 2019
- Acronym
- Dante
- Status last verified
- Aug 2024
- First submitted
- 22 Nov 2021
- Last updated
- 9 Jan 2025
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Varrassi G, Hanna M, Coaccioli S, Fabrizzi P, Baldini S, Kruljac I, Brotons C, Perrot S. Dexketoprofen Trometamol and Tramadol Hydrochloride Fixed-Dose Combination in Moderate to Severe Acute Low Back Pain: A Phase IV, Randomized, Parallel Group, Placebo, Active-Controlled Study (DANTE). Pain Ther. 2024 Aug;13(4):1007-1022. doi: 10.1007/s40122-024-00623-4. Epub 2024 Jun 26.
PubMed 38922520
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized, Double-blind, Placebo-controlled, Parallel Arm Group Study Evaluating Analgesic Efficacy and Safety of Dexketoprofen Trometamol and Tramadol Hydrochloride on Moderate to Severe Acute Pain in Patients With Acute Low Back Pain
- ClinicalTrials.gov ID
- NCT05170841
- Acronym / sponsor ID
- Dante / MEIN/18/DEX-LBP/001
- Conditions
- Low Back Pain
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 538 participants (actual)
- Lead sponsor
- Menarini International Operations Luxembourg SAIndustry (pharma, biotech, devices)
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 4 May 2022 (actual)
- Study completion
- 4 May 2022 (actual)
- First posted
- 28 Dec 2021 (actual)
- Results
- Posted 9 Jan 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A randomized, double-blind, study to evaluate the analgesic efficacy and safety of Dexketoprofen trometamol and Tramadol hydrochloride combination versus placebo on moderate to severe acute pain in patients with acute low back pain.
Detailed description
This is a multicenter, randomized, double-blind, double-dummy, parallel group, placebo-controlled study encompassing 2 study phases: a single-dose phase (first 8 hours) and a multiple-dose phase starting after the single-dose phase (from 8h until day 5).
Study population will be of male or female patients aged 18 years to 65 years with acute low back pain of moderate to severe intensity, whose onset of the current acute low back pain episode is within 48 hours prior to Screening. Patients with or without radiculopathy will be included, excluding those with neurological signs, according to the Quebec Task Force classification. Patients experiencing a new episode of low back pain will be eligible only if preceded by a period of at least 2 months without any low back pain. Patients should be free from analgesic due to previously administered pain killer (immediate or slow release formulations), according to exclusion criteria.
Approximately 612 patients will be screened to achieve 510 patients randomly assigned to study treatment.
In the single-dose phase patients will receive a single-dose treatment, consisting of 1 film-coated tablet and 2 capsules which have to be orally administered together at the same time (Day 1). The multiple-dose phase will begin 8 hours after the first dose. The patients assigned to Dexketoprofen/Tramadol fixed combination or Tramadol 100 milligram (mg) during the single-dose phase will continue to receive the same treatment during the multiple-dose phase; however, the patients assigned to receive placebo during the single-dose phase will either receive Dexketoprofen/Tramadol fixed combination or Tramadol 100 mg during the multiple-dose phase.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- 2 study phases: a single-dose phase (first 8 hours) and a multiple-dose phase starting after the single-dose phase (from 8h until Day 5).In the single-dose phase the patients will receive a single dose treatment, consisting of 1 film-coated tablet and 2 capsules which must be orally administered together at the same time (Day 1). The multiple-dose phase will begin 8 hours after the first dose. The patients assigned to Dexketoprofen/Tramadol fixed combination or Tramadol 100 mg during the single-dose phase will continue to receive the same treatment during the multiple-dose phase; however, the patients assigned to receive placebo during the single-dose phase will either receive Dexketoprofen/Tramadol fixed combination or Tramadol 100 mg during the multiple-dose phase.
| Arm | Type | Receives |
|---|---|---|
| Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg treatment | Active comparator | Drug: Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mgTwo phase intervention. Single Dose Phase (time 0 - time 8h) and Multiple Dose phase (time 8h - Day 5) In this arm patients will receive during each phase film coated tablets (administered as one tablet) |
| Tramadol Hydrochloride 100 mg treatment | Active comparator | Drug: Tramadol Hydrochloride 100 mgTwo phase intervention. Single Dose Phase (time 0 - time 8h) and Multiple Dose Phase (time 8h - Day 5) In this arm patients will receive during each phase (administered as 2 capsules of Tramadol 50 mg) |
| Placebo and Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg treatment | Placebo comparator | Drug: Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg, Drug: PlaceboTwo phase intervention. Single dose phase (time 0 - time 8h) and Multiple Dose Phase (time 8h - Day 5). SINGLE DOSE PHASE: Placebo film-coated tablets matching Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg MULTIPLE DOSE PHASE: Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg film coated tablets (administered as one tablet) |
| Placebo and Tramadol Hydrochloride 100 mg | Placebo comparator | Drug: Tramadol Hydrochloride 100 mg, Drug: PlaceboTwo phase intervention. Single Dose Phase (time 0 - time 8h) and Multiple Dose Phase (time 8h - Day 5). SINGLE DOSE PHASE: Placebo capsules matching active comparator (administered as 2 capsules of Tramadol 50 mg) MULTIPLE DOSE PHASE: Tramadol Hydrochloride 100 mg (administered as 2 capsules of Tramadol 50 mg) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Properly executed written informed consent.
- Male or female patients aged 18 years to 65 years.
- Patients with acute low back reporting pain of at least moderate intensity at Screening (NRS score ≥ 5). The onset of the current acute low back pain episode is within 48 hours prior to Screening.
- Patients with or without radiculopathy will be included, excluding those with neurological signs, according to the Quebec Task Force classification.
- Naïve patients to any low back pain or patients with previous history of low back pain experiencing a new episode, preceded by a period of at least 2 months without any low back pain prior to Screening.
Key exclusion criteria (29 listed)
- Patients who are judged by the Investigator not to be suitable candidates for the study treatments and the Rescue Medication (RM) based on their medical history, physical examination, Concomitant Medication (CM) and concurrent systemic diseases.
- Clinically significant abnormalities in the vital signs as per Investigator's judgment.
- Patients with acute low back pain and radiation to limb with presence of neurologic signs (focal weakness, asymmetry of reflexes, sensory loss in a dermatome, or loss of bowel, bladder, or sexual function) according to Quebec Task Force Classification.
- History of hypersensitivity to the study treatments, RM or to any other nonsteroidal anti-inflammatory drugs (NSAIDs), or opioids.
- Known photoallergic or phototoxic reactions during treatment with ketoprofen or fibrates.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mgAlso: SkudexaAdministered as one single tablet to be taken every 8 hours | Drug | Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg treatment, Placebo and Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg treatment |
| Tramadol Hydrochloride 100 mgAlso: TramadolAdministered as two capsules with 50 mg each to be taken every 8 hours | Drug | Placebo and Tramadol Hydrochloride 100 mg, Tramadol Hydrochloride 100 mg treatment |
| PlaceboAdministered as one tablet if matching Dexketoprofen Trometamol 25 mg and Tramadol Hydrochloride 75 mg or two capsules if matching Tramadol Hydrochloride 100 mg | Drug | Placebo and Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg treatment, Placebo and Tramadol Hydrochloride 100 mg |
Primary outcome
Time to First Achieve a Numeric Rating Scale-Pain Intensity Score <4 or a Pain Intensity Reduction of ≥30% From Drug Intake Till 8 Hours After the First Dose
Time frame: 8 hours from first intake (referring to first 8 hours of Single Dose Phase)
Time to first achieve a Numeric Rating Scale-Pain Intensity (NRS-PI) score of <4 or a pain intensity reduction ≥30% from drug intake till 8 hours after the first dose. Numeric Rate Scale-Pain Intensity is a Patients rated Pain Intensity scale using an 11-point Numeric Rate Scale (0 no pain; 10 worst pain).
25 secondary outcomes
Total Pain Relief (TOTPAR) at 4h After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol
Time frame: From t=o to T=4 hours
Total Pain Relief (TOTPAR) at 6h After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol
Time frame: T=0 to T=6h
Total Pain Relief (TOTPAR) at 8h After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol
Time frame: From T=0 to T=8h
Total Pain Relief (TOTPAR) at 6h After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Placebo
Time frame: From T=0 to T=6h
Total Pain Relief (TOTPAR) at 8h After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Placebo
Time frame: Form T=0 to T=8h
Percentage of Maximum TOTPAR (%Max TOTPAR) at 4 Hours After the First Dose- Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol
Time frame: Form T=0 to T=4h
Percentage of Maximum TOTPAR (%Max TOTPAR) at 6 Hours After the First Dose- Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol
Time frame: Form T=0 to T=6h
Percentage of Maximum TOTPAR (%Max TOTPAR) at 8 Hours After the First Dose- Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol
Time frame: Form T=0 to T=8h
Percentage of Maximum TOTPAR (%Max TOTPAR) at 6 Hours After the First Dose- Single Dose Phase - Dexketoprofen/Tramadol vs Placebo
Time frame: Form T=0 to T=6h
Percentage of Maximum TOTPAR (%Max TOTPAR) at 8 Hours After the First Dose- Single Dose Phase - Dexketoprofen/Tramadol vs Placebo
Time frame: Form T=0 to T=8h
Percentage of Patients Achieving at Least 50% of Maximum TOTPAR at 4 Hours After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol
Time frame: Form T=0 to T=4h
Percentage of Patients Achieving at Least 50% of Maximum TOTPAR at 6 Hours After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol
Time frame: Form T=0 to T=6h
Percentage of Patients Achieving at Least 50% of Maximum TOTPAR at 8 Hours After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Tramadol
Time frame: Form T=0 to T=8h
Percentage of Patients Achieving at Least 50% of Maximum TOTPAR at 4 Hours After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Placebo
Time frame: Form T=0 to T=4h
Percentage of Patients Achieving at Least 50% of Maximum TOTPAR at 6 Hours After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Placebo
Time frame: Form T=0 to T=6h
Percentage of Patients Achieving at Least 50% of Maximum TOTPAR at 8 Hours After the First Dose - Single Dose Phase - Dexketoprofen/Tramadol vs Placebo
Time frame: Form T=0 to T=8h
Total Pain Relief (TOTPAR) at 24h After the First Dose - Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol
Time frame: Form T=0 to T=24h
Total Pain Relief (TOTPAR) at 48h After the First Dose - Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol
Time frame: Form T=0 to T=48h
Total Pain Relief (TOTPAR) at 72h After the First Dose - Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol
Time frame: Form T=0 to T=72h
Percentage of Maximum TOTPAR (%Max TOTPAR) at 24 Hours After the First Dose- Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol
Time frame: Form T=0 to T=24h
Percentage of Maximum TOTPAR (%Max TOTPAR) at 48 Hours After the First Dose- Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol
Time frame: Form T=0 to T=48h
Percentage of Maximum TOTPAR (%Max TOTPAR) at 72 Hours After the First Dose- Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol
Time frame: Form T=0 to T=72h
Percentage of Maximum TOTPAR (%Max TOTPAR) at 96 Hours After the First Dose- Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol
Time frame: Form T=0 to T=96h
Percentage of Patients Achieving at Least 50% of Maximum TOTPAR at 48 Hours After the First Dose - Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol
Time frame: Form T=0 to T=48h
Percentage of Patients Achieving at Least 50% of Maximum TOTPAR at 72 Hours After the First Dose - Multiple Dose Phase - Dexketoprofen/Tramadol vs Tramadol
Time frame: Form T=0 to T=72h
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Jan 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38922520Varrassi G, Hanna M, Coaccioli S, Fabrizzi P, Baldini S, Kruljac I, Brotons C, Perrot S. Dexketoprofen Trometamol and Tramadol Hydrochloride Fixed-Dose Combination in Moderate to Severe Acute Low Back Pain: A Phase IV, Randomized, Parallel Group, Placebo, Active-Controlled Study (DANTE). Pain Ther. 2024 Aug;13(4):1007-1022. doi: 10.1007/s40122-024-00623-4. Epub 2024 Jun 26.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Giustino Varrassi, Professor principal investigator
University of L'Aquila
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Dexketoprofen Trometamol 25 mg/Tramadol Hydrochloride 75 mg and Tramadol Hydrochloride 100 mg in people with Low Back Pain, run by Menarini International Operations Luxembourg SA at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Jan 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 9 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to First Achieve a Numeric Rating Scale-Pain Intensity Score <4 or a Pain Intensity Reduction of ≥30% From Drug Intake Till 8 Hours After the First Dose (time frame: 8 hours from first intake (referring to first 8 hours of Single Dose Phase)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05170841, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Jan 2025.