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Acute Low Back PainPhase 3NCT04968158

Efficacy and Safety of Fixed-dose Combination of Etoricoxib/Tramadol vs Acetaminophen/Tramadol for Acute Low Back Pain

A Phase 3 study testing Etoricoxib 90 mg / Tramadol 50 mg and Acetaminophen 325 mg / Tramadol 37.5 mg in people with Acute Low Back Pain, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Phase IIIb, longitudinal, multicenter, randomized, open-label clinical trial to evaluate the efficacy and safety of the fixed-dose combination of etoricoxib 90 mg and tramadol 50 mg compared with fixed-dose therapy of acetaminophen 325 mg and tramadol 37.5 mg for the management of acute low back pain. Read more about this study

Who is it for?
Ages 18 to 60 yearsHealthy volunteers can take part
Conditions the study is for
Acute Low Back Pain
What is being tested?
Etoricoxib 90 mg / Tramadol 50 mg and Acetaminophen 325 mg / Tramadol 37.5 mg
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
124 participants
Where
1 siteMexico
Study dates
29 Nov 2021to 10 Apr 2022
Phase
Phase 3
Are there results?
None posted in the registry

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 60 years
  • All sexes
  • Healthy volunteers accepted
  • Adult

Who may be able to join

  • Any sex.
  • That the subject agree to participate in the study and give informed consent in writing.
  • Age> 18 years and ≤ 60 years of age at the beginning of the study.
  • Diagnosis of acute low back pain as a first-time episode or after another episode, maximum 6 months before and lasting no more than 6 weeks.
  • Patient with low back pain reported as moderate to severe intensity (VAS> 4 cm).
  • Women of childbearing age who have an acceptable contraceptive method (eg barrier, oral hormonal, injectable, subdermal).

Who cannot join

  • Patients in whom the study drug is contraindicated for medical reasons.
  • Patients with an allergy or hypersensitivity to the active principle, study drugs, related products or excipients.
  • Positive pregnancy test, women who are pregnant, breastfeeding or planning a pregnancy while conducting the study.
  • A significant history of gastrointestinal disorders (for example: Gastric ulcer, Crohn's disease, Ulcerative Colitis, etc.).
  • Previous treatment with opioids and / or NSAIDs (Non-Steroidal Anti-Inflammatory Drugs) reported in the medical history in the last 72 hours at study entry.
  • Patients with a history of alcohol or drug abuse in the last year according to DSM-V (Diagnostic and Statistical Manual of Mental Disorders).
Show all 18Show fewer
  • Patients who are receiving monoamine oxidase inhibitors (MAOIs) or who have received them within the past 2 weeks.
  • Patients with a history of established ischemic heart disease, peripheral arterial disease and / or cerebrovascular disease (including patients who have recently undergone coronary artery bypass grafting or angioplasty).
  • Patients with status epileptic seizure disorders and grand mal seizures.
  • Patients with a history of severe acute or chronic liver failure.
  • Patients with a history of moderate to severe renal failure.
  • Patient with a history of chronic pain (eg, fibromyalgia, Paget's disease, bone pain induced by metastatic cancer).
  • Low back pain due to major trauma (eg vertebral fracture, post-traumatic spondylolisthesis), or due to a visceral disorder (eg dysmenorrhea, endometriosis).
  • At medical criteria, a disease that affects the prognosis and prevents outpatient management, for example, but not restricted to: intestinal obstruction, paralytic ileus, end-stage cancer, kidney, heart, respiratory or liver failure or mental illness or with surgical procedures or scheduled hospitals.
  • History / presence of any disease or condition that, in the Investigator's opinion, could pose a risk to the patient or confuse the efficacy and safety of the study results. ----Patients with symptoms suggesting an active COVID-19 infection (i.e., fever, cough, dyspnea) and / or contact in the past 14 days with a suspected or positive COVID-19 patient.
  • Oncological patients (except basal cell skin cancer) or with serious diseases that, in the opinion of the investigator, have a serious prognosis or a life expectancy of less than 1 year, as well as mental illnesses.
  • The patient is participating in another clinical study involving an investigational treatment or participated in one in the previous 4 weeks.
  • Patients whose participation in the study may be influenced (employment relationship with the research center or sponsor, inmates, etc.).

Trial locations and contacts

1 site in 1 country.

Mexico1 site

  • Laboratorio Silanes, S.A. de C.V.

    Mexico City, 11000

Other trials in Mexico

About this study

Official title: Confirmatory Efficacy and Safety Study of the Fixed-dose Combination of Etoricoxib / Tramadol Versus Acetaminophen / Tramadol for the Management of Acute Low Back Pain.

Phase IIIb, longitudinal, multicenter, randomized, open-label clinical trial to evaluate the efficacy and safety of the fixed-dose combination of etoricoxib 90 mg and tramadol 50 mg compared with fixed-dose therapy of acetaminophen 325 mg and tramadol 37.5 mg for the management of acute low back pain.

Read the detailed description

Patients with back pain from the level of the lowest rib to the gluteal crease, with or without radiation to the legs, as a first-time episode or after another at least 6 months before and lasting no more than 6 weeks, that in the opinion of the doctor requires treatment with the combination of an anti-inflammatory and an analgesic. Study to evaluate the efficacy and safety of the fixed-dose combination of etoricoxib 90 mg and tramadol 50 mg compared with the fixed-dose therapy of acetaminophen 325 mg and tramadol 37.5 mg for the management of acute low back pain. Evaluate and compare the average change in pain reported through the VAS at 3, 5 and 7 days with respect to its baseline measurement by treatment group. An exploratory analysis of the data will be carried out to identify aberrant, outliers, or missing values. To present the numerical variables, the measures of central tendency and dispersion appropriate to the distribution of the data will be used and the categorical variables will be expressed as frequency and percentage.

Being tested
Etoricoxib 90 mg / Tramadol 50 mg, Acetaminophen 325 mg / Tramadol 37.5 mg
Keywords
Back pain, Etoricoxib, Tramadol, Fixed dose
Medical subject headings
Back Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Etoricoxib 90 mg / Tramadol 50 mgDrug

    Also called E/T

    One packet diluted in 100 ml of water, every 24 hours of 90 mg/50 mg.

  • Acetaminophen 325 mg / Tramadol 37.5 mgDrug

    Also called A/T

    One tablet, every 8 hours of 325 mg/ 37.5 m

Study groups in NCT04968158
Study groupRoleWhat they receive
Group A: Etoricoxib/TramadolExperimentalAdministered orally, one packet of etoricoxib / tramadol granules diluted in 100 ml of water, every 24 hours for 7 days.
Receives: Drug: Etoricoxib 90 mg / Tramadol 50 mg
Group B: Acetaminophen / TramadolActive comparatorAdministered orally, one tablet, every 8 hours, for 7 days.
Receives: Drug: Acetaminophen 325 mg / Tramadol 37.5 mg

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Average change in reported pain

    Compare the average change in pain reported through the VAS (Visual Analog Scale) per treatment group. In a straight 10 centimeter line in which one end means no pain and the other end means the worst pain imaginable, the participants mark the amount of pain feeling at that moment

    Measured: Baseline, 3, 5 and 7 days.

Secondary outcomes (4)

  1. Proportion of patients with a 30% reduction in pain intensity

    Describe the proportion of patients who reported a 30% reduction in pain intensity measure by the VAS (Visual Analog Scale) per treatment group. In a straight 10 centimeter line in which one end means no pain and the other end means the worst pain imaginable, the participants mark the amount of pain feeling at that moment.

    Measured: Baseline and 7 days.

  2. Degree of disability due to low back pain

    Evaluate the degree of disability due to low back pain measured through the Oswestry disability scale per treatment group. It measures the limitations in daily activities in the presence of pain in the lumbar region, consists of 10 questions with 6 possible answers considering the intensity of the pain, basic activities of daily life such as: personal care, sexual activity, sleep, travel and social life.

    Measured: Baseline and 7 days.

  3. Degree of inability to perform daily activities

    Assess the degree of inability to perform daily activities through the Roland-Morris scale per group. It´s a self-applied scale where the extreme values range between 0 (absence of disability) and 24 (maximum disability) and is categorized according to the relevance of the score obtained where the optimal threshold of variation is 3 and 4 points.

    Measured: Baseline and 7 days.

  4. Adverse events

    Compare the frequency of adverse events presented during the study between the treatment groups.

    Measured: 7 days.

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Jul 2021
  2. Study start29 Nov 2021
  3. Primary completion15 Mar 2022
  4. Study completion10 Apr 2022

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
124 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04968158
Sponsor's protocol ID
SIL-30138-III-21(1)
Status last verified
Apr 2022
First submitted
13 Jul 2021
Last updated
13 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • GBD 2017 Disease and Injury Incidence and Prevalence Collaborators. Global, regional, and national incidence, prevalence, and years lived with disability for 354 diseases and injuries for 195 countries and territories, 1990-2017: a systematic analysis for the Global Burden of Disease Study 2017. Lancet. 2018 Nov 10;392(10159):1789-1858. doi: 10.1016/S0140-6736(18)32279-7. Epub 2018 Nov 8.

    PubMed 30496104

  • Soto-Padilla M, Espinosa-Mendoza RL, Sandoval-Garcia JP, Gomez-Garcia F. [Comparative study between plate-graft, cage-plate and peek cage in cervical arthrodesis for cervical stenosis]. Acta Ortop Mex. 2015 Jan-Feb;29(1):40-5. Spanish.

    PubMed 26999925

  • Casser HR, Seddigh S, Rauschmann M. Acute Lumbar Back Pain. Dtsch Arztebl Int. 2016 Apr 1;113(13):223-34. doi: 10.3238/arztebl.2016.0223.

    PubMed 27120496

  • Guevara-Lopez U, Covarrubias-Gomez A, Elias-Dib J, Reyes-Sanchez A, Rodriguez-Reyna TS; Consensus Group of Practice Parameters to Manage Low Back Pain. Practice guidelines for the management of low back pain. Consensus Group of Practice Parameters to Manage Low Back Pain. Cir Cir. 2011 May-Jun;79(3):264-79, 286-302. English, Spanish.

    PubMed 22381000

  • Gonzalez Maza C, Moscoso Lopez L, Ramirez Elizalde G, Abdo Andrade A. [Multimodal treatment of chronic unspecific low back pain]. Acta Ortop Mex. 2010 Mar-Apr;24(2):88-94. Spanish.

    PubMed 20831016

  • Chandanwale AS, Sundar S, Latchoumibady K, Biswas S, Gabhane M, Naik M, Patel K. Efficacy and safety profile of combination of tramadol-diclofenac versus tramadol-paracetamol in patients with acute musculoskeletal conditions, postoperative pain, and acute flare of osteoarthritis and rheumatoid arthritis: a Phase III, 5-day open-label study. J Pain Res. 2014 Aug 12;7:455-63. doi: 10.2147/JPR.S67817. eCollection 2014.

    PubMed 25152629

  • Bravo L, Mico JA, Berrocoso E. Discovery and development of tramadol for the treatment of pain. Expert Opin Drug Discov. 2017 Dec;12(12):1281-1291. doi: 10.1080/17460441.2017.1377697. Epub 2017 Sep 17.

    PubMed 28920461

  • Dhillon S. Tramadol/paracetamol fixed-dose combination: a review of its use in the management of moderate to severe pain. Clin Drug Investig. 2010;30(10):711-38. doi: 10.2165/11205830-000000000-00000.

    PubMed 20701403

  • Subedi M, Bajaj S, Kumar MS, Yc M. An overview of tramadol and its usage in pain management and future perspective. Biomed Pharmacother. 2019 Mar;111:443-451. doi: 10.1016/j.biopha.2018.12.085. Epub 2018 Dec 27.

    PubMed 30594783

  • Zuqui-Ramirez MA, Belalcazar-Lopez VM, Urenda-Quezada A, Gonzalez-Rebatu Y Gonzalez A, Sander-Padilla JG, Lugo-Sanchez LA, Rodriguez-Vazquez IC, Rios-Brito KF, Arguedas-Nunez MM, Canales-Vazquez E, Gonzalez-Canudas J. Multimodal Analgesia Approach in Acute Low Back Pain Management: A Phase III Study of a Novel Analgesic Combination of Etoricoxib/Tramadol. Pain Ther. 2024 Dec;13(6):1511-1528. doi: 10.1007/s40122-024-00653-y. Epub 2024 Sep 10.

    PubMed 39256291

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Etoricoxib 90 mg / Tramadol 50 mg and Acetaminophen 325 mg / Tramadol 37.5 mg in people with Acute Low Back Pain, run by Laboratorios Silanes S.A. de C.V. at 1 site in Mexico.

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 6 inclusion and 18 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 13 Apr 2022. 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 Mexico. 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. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

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?

Average change in reported pain (time frame: Baseline, 3, 5 and 7 days.). 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 NCT04968158, which also lists 10 linked publications.

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 13 Apr 2022.

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