Low Back PainPhase 4NCT05222724
Efficacy of the Combination of Ibuprofen and Paracetamol in Acute Non-specific Low Back Pain
A Phase 4 study testing Tachifene and Brufen in people with Low Back Pain, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 11 sites in 2 countries.
Trial summary
The aim of the present study is to assess the efficacy and safety of paracetamol/ibuprofen Fixed Dose Combination (FDC) compared to ibuprofen in patients with uncomplicated non-specific acute low back pain after a 3-day treatment period. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Low Back Pain
- What is being tested?
- Tachifene and Brufen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 11 sitesin 2 countries
- Study dates
- 1 Dec 2021to 5 Oct 2022
- Phase
- Phase 4
- 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 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Male and female patients of any ethnic origin between 18 and 64 years of age (limits included).
- Patients with uncomplicated and localized acute low back pain or acute exacerbation of chronic low back pain (not radiating below the gluteal fold), with moderate/severe pain at baseline. Minimum VAS score ≥ 40 mm at screening visit.
- Women of childbearing potential and women with no menses for a period < 12 months must have a negative pregnancy test at Visit 0 and have to agree not to start a pregnancy from the signature of the informed consent up to the Final Visit/Visit 2, using an appropriate birth control method such as combined oestrogen-progestin containing hormonal contraceptives (e.g., oral, injectable, transdermal), progestin-only hormonal contraceptives (e.g., oral, injectable, implantable), intrauterine device (IUD) or Intrauterine hormone-releasing System (IUS) in combination with male condom, bilateral tubal occlusion, vasectomised partner, sexual abstinence. The following definitions will be considered:
- Woman of childbearing potential (WOCBP): i.e., fertile, following menarche and until becoming post-menopausal, unless permanently sterile. Permanent sterilization methods include hysterectomy, bilateral salpingectomy and bilateral oophorectomy.
- A postmenopausal state is defined as no menses for 12 months without an alternative medical cause.
- Patients legally capable of giving their consent to participate in the study and available to sign and date the written informed consent.
Who cannot join
- Known hypersensitivity or allergy to the active ingredients and/or to any component of the study medications.
- Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
- Lactating and pregnant women.
- Clinically significant abnormalities on physical examination, vital signs or laboratory tests at Visit 0 which in the opinion of the Investigator could interfere with the study procedures or endpoints evaluation.
- Suspicious or confirmed COVID-19 infection at time of screening visit.
- History of cervical, thoracic, or lumbosacral pain for ≥75% of the time in the last year, or of any other Low Back Pain episode in the last 3 months that required pharmacological treatment with an opioid analgesic.
Show all 26Show fewer
- Patients with:
- serious spinal pathology; spinal surgery in the year prior to screening or history of more than one spinal surgery; history of severe lumbar spinal stenosis; ankylosing spondylitis; lumbosciatalgia; herniated disc or radiculopathy; severe arthritis and osteoporosis; muscular diseases, such as myositis, poliomyelitis, muscular dystrophy and myotonia; fibromyalgia; myasthenia grave; fracture or recent history of violent trauma of the back; structural deformity of the back;
- history of hypersensitivity to aspirin or any other non-steroidal anti-inflammatory drugs; suspicion of inflammatory, infective or neoplastic cause of pain; non- specific back symptoms related to abdominal, pelvic or thoracic pathology sensory and/or motor deficits in lower extremities;
- history of gastroduodenal ulcer or bleeding;
- history of severe cardiac, hepatic or renal insufficiency;
- current anticoagulant therapy;
- previous treatment with anticoagulants in the seven days before the screening visit;
- concomitant use of physical or alternative therapies to treat current episode of pain;
- local steroid injection for any reasons within previous 30 days;
- alcohol or drug-addition or abuse;
- cancer, not in remission or in remission less than 1 year;
- active influenza or other viral syndrome; immunosuppression; systematically unwell; unexplained significant weight loss;
- widespread neurological symptoms (including cauda equina syndrome) or any brain disease; ever suffered from any brain damage or have been in a coma; epilepsy or seizure;
- active or suspected oesophageal, gastric, pyloric channel, or duodenal ulceration, or bleeding in the last 30 days;
- blood-formation disturbance;
- renal and/or hepatic failure;
- acute hepatitis;
- acetylsalicylic acid-triggered asthma;
- history of asthma;
- glucose-6-phosphate dehydrogenase-deficient patients; glutathione deficiency, dehydration, chronic malnutrition; anaemia.
Trial locations and contacts
11 sites in 2 countries.
11 sites in 2 countries
Poland8 sites
In-Vivo sp z o. o.
Bydgoszcz, 85-048
Przychodnia "Przy Szapitalu"
Bydgoszcz, 85-094
Zespół Porani Specjalistycznych Reumed Filia nr 1 Wallenroda
Lublin, 20-607
Centrum Medyczne Pratia Poznan
Skorzewo, 60-185
Nasz Lekarz Przychodnie Medyczne
Torun, 87-100
Centrum Medyczne AstiMed
Warsaw, 01-864
Centrum Medyczne PRATIA
Warsaw, 01-868
Centrum Medyczne Reuma Park
Warsaw, 02-691
Italy3 sites
Università degli Studi della Campania "Luigi Vanvitelli"
Caserta, CE, 81100
Azienda Ospedaliera Universitaria Policlinico G.Rodolico
Catania, 95123
Azienda Ospedaliera Universitaria Integrata di Verona
Verona, 37126
About this study
Official title: Efficacy and Safety of the Combination of Ibuprofen and Paracetamol Versus Ibuprofen in Monotherapy in Acute Low Back Pain (LBP)
The aim of the present study is to assess the efficacy and safety of paracetamol/ibuprofen Fixed Dose Combination (FDC) compared to ibuprofen in patients with uncomplicated non-specific acute low back pain after a 3-day treatment period.
Read the detailed description
This is a Phase IV, multicenter, international, open-label, parallel-group study.
The study will be conducted at sites located in Italy, Poland and Hungary. The sites will be outpatient facilities and hospitals. A total of 176 patients are planned to be included in the study This trial will be conducted in accordance with the study protocol, GCPs, Declaration of Helsinki (including up-to-date versions) and applicable regulatory requirements.
The present clinical trial aims to evaluate the efficacy and safety of the combination of 2 tablets of paracetamol 500 mg/ibuprofen 150 mg administered 3 times daily, in the management of patients with acute non-specific Low Back Pain (LBP) condition.
- Conditions
- Low Back Pain
- Being tested
- Tachifene, Brufen
- Keywords
- low back pain, ibuprofen, Paracetamol, Tachifene®
- 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.
TachifeneDrug
Also called paracetamol 500 mg/ibuprofen 150 mg
paracetamol 500 mg/ibuprofen 150 mg FDC, film-coated tablets. Two tablets 3 times daily for 3 days (i.e., every 8 hours ± 1 hour).
BrufenDrug
Also called ibuprofen 600 mg
ibuprofen 600 mg, film coated tablets. One tablet 3 times daily for 3 days (i.e., every 8 hours ± 1 hour).
| Study group | Role | What they receive |
|---|---|---|
| Tachifene | Experimental | paracetamol 500 mg/ibuprofen 150 mg FDC, film-coated tablets. Two tablets 3 times daily for 3 days (i.e., every 8 hours ± 1 hour). Receives: Drug: Tachifene |
| Brufen | Active comparator | ibuprofen 600 mg, film coated tablets. One tablet 3 times daily for 3 days (i.e., every 8 hours ± 1 hour). Receives: Drug: Brufen |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary endpoint will be the area under the pain intensity difference-versus-time curve of Low Back Pain scores up to 3 days of treatment
The pain intensity difference will be considered to be the difference in VAS pain intensity between one time-point and the baseline. The sum of the pain intensity differences (SPID) will be the sum of the average of two consecutive pain intensity differences multiplied by the time-interval between two time points.
Measured: From Day 1 up to Day 3 (±1)
Secondary outcomes (7)
Change in Visual Analogue Scale 0-10 cm (100 mm)
Change in Visual Analogue Scale score at baseline (Visit 0) and at the end of study (Visit 2).The Visual Analogue Scale consists of a continuous horizontal line of 10 cm (100 mm) in length, on a piece of paper, with ends labelled as the extremes of pain, from 0 (left side): "no pain", to 10 (right side): "pain as bad as it could be". Patients will be asked to place a line with a pen perpendicular to the VAS line and intersecting the VAS line at the point that represents their current pain intensity.
Measured: Day 0 and Day 8 (±1)
Change from baseline up to the end of the study in Visual Analogue Scale 0-10 cm (100 mm) score.
Change from baseline up to the end of the study in VAS score, assessed at baseline (Visit 0) and Visit 2, and daily recorded in the patient diary during the whole home-stay period
Measured: From Day 0 to Day 8 (±1)
Change from baseline up to the end of the study in the hand-to-floor distance
Change from baseline up to the end of the study in the hand-to-floor distance assessed at Visits 0, 1 and 2, measured by a cm graduated bar.
The Hand-to-floor-distance, also called fingertip-to-floor test or mobility assessment, is a test to evaluate the mobility of both the whole spine and the pelvis in the overall motion of bending forward.
The Investigator will ask the patient to stay erect on a platform 20-cm high with shoes removed and feet together. The patient will be asked to bend forward as far as possible and try to touch the floor with his/her fingers, while maintaining the knees, arms, and fingers fully extended. The vertical distance between the tip of the middle finger and the platform will be measured through a simple cm graduated bar (0 value at floor). The vertical distance between the platform and tip of the middle finger is positive when the subject does not reach the platform and negative when he/she can go further.
Measured: Day 0, Day 4 and Day 8 (±1)
Change from baseline up to the end of the study in the in the degree of improvement in the functional disability
Change from baseline up to the end of the study in the in the degree of improvement in the functional disability, assessed at Visits 0, 1 and 2, measured by the Oswestry Disability Index (ODI).
The Oswestry Disability Indexcontains 10 sections: (1) pain intensity, (2) personal care (washing/dressing), (3) lifting, (4) walking, (5) sitting, (6) standing, (7) sleeping, (8) sex life (if applicable), (9) social life, (10) travelling.
Each section contains six statements that are scored from 0 (minimum degree of difficulty in that activity) to 5 (maximum degree of difficulty): if the first statement is marked, the section score is=0; if the last statement is marked, it is=5.
The total score is the Oswestry Disability Index score and is obtained by summing up the scores of all sections, giving a maximum of 50 points.
The final score is expressed as a percentage with the following formula: (total score/ (5 × number of questions answered) × 100%.
Measured: Day 0, Day 4 and Day 8 (±1)
Change in the patients' global impression
Change in the patients' global impression at Visits 1 and 2, measured by the Patients' Global Impression of Change (PGIC) scale.The patient will give the evaluation about his/her rating of overall improvement (if any) relative to a baseline state at the beginning of the treatment, according to the PGIC 7-point scale (Hurst and Bolton, 2004):
- No change (or condition has got worse)
- Almost the same, hardly any change at all
- A little better, but no noticeable change
- Somewhat better, but the change has not made any real difference
- Moderately better and a slight but noticeable change
- Better and a definite improvement that has made a real and worthwhile difference
- A great deal better and a considerable improvement that has made all the difference
Measured: Day 4 and Day 8 (±1)
Change in the clinical global impression
Change in the clinical global impression at Visits 1 and 2, measured by the Clinical Global Impression-Improvement (CGI-I) scale.
The Clinical Global Impression-Improvement (CGI-I) scale provides an overall clinician-determined summary evaluation of the treatment. the results in the appropriate source documents and on eCRF.
The Investigator will assign a score based on how much the patient's illness has improved or worsened relative to a baseline state at the beginning of the treatment, according to the following 7-point scale (Guy, 1976):
- Very much improved since the initiation of treatment
- Much improved
- Minimally improved
- No change from the initiation of treatment
- Minimally worse
- Much worse
- Very much worse since the initiation of treatment
Measured: Day 4 and Day 8 (±1)
Monitoring the frequency of adverse events
Safety will be assessed by monitoring the frequency of adverse events in each treatment group.
AEs will be summarized using the total number of AEs, the total number and percentage of patients who experienced an AE, and the number and percentage of patients who experienced an AE within each System Organ Class (SOC) and by preferred term.
Measured: 8 (±1) days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2022
- Study start1 Dec 2021
- Primary completion5 Oct 2022
- Study completion5 Oct 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Masking
- None (open label)
- Enrolment
- 176 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.A
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- TFS Trial Form Support
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05222724
- Sponsor's protocol ID
- 147(Z)WO20157
- Other IDs
- 2020-005278-86
- Status last verified
- Jan 2023
- First submitted
- 24 Jan 2022
- Last updated
- 31 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of the Combination of Ibuprofen and Paracetamol Versus Ibuprofen in Monotherapy in Acute Low Back Pain (LBP)
- ClinicalTrials.gov ID
- NCT05222724
- Acronym / sponsor ID
- 147(Z)WO20157
- Conditions
- Low Back Pain
- Keywords
- low back pain, ibuprofen, Paracetamol, Tachifene®
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Aziende Chimiche Riunite Angelini Francesco S.p.AIndustry (pharma, biotech, devices)
- Collaborators
- TFS Trial Form Support
- Study start
- 1 Dec 2021 (actual)
- Primary completion
- 5 Oct 2022 (actual)
- Study completion
- 5 Oct 2022 (actual)
- First posted
- 3 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The aim of the present study is to assess the efficacy and safety of paracetamol/ibuprofen Fixed Dose Combination (FDC) compared to ibuprofen in patients with uncomplicated non-specific acute low back pain after a 3-day treatment period.
Detailed description
This is a Phase IV, multicenter, international, open-label, parallel-group study.
The study will be conducted at sites located in Italy, Poland and Hungary. The sites will be outpatient facilities and hospitals. A total of 176 patients are planned to be included in the study This trial will be conducted in accordance with the study protocol, GCPs, Declaration of Helsinki (including up-to-date versions) and applicable regulatory requirements.
The present clinical trial aims to evaluate the efficacy and safety of the combination of 2 tablets of paracetamol 500 mg/ibuprofen 150 mg administered 3 times daily, in the management of patients with acute non-specific Low Back Pain (LBP) condition.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tachifene | Experimental | Drug: Tachifeneparacetamol 500 mg/ibuprofen 150 mg FDC, film-coated tablets. Two tablets 3 times daily for 3 days (i.e., every 8 hours ± 1 hour). |
| Brufen | Active comparator | Drug: Brufenibuprofen 600 mg, film coated tablets. One tablet 3 times daily for 3 days (i.e., every 8 hours ± 1 hour). |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Male and female patients of any ethnic origin between 18 and 64 years of age (limits included).
- Patients with uncomplicated and localized acute low back pain or acute exacerbation of chronic low back pain (not radiating below the gluteal fold), with moderate/severe pain at baseline. Minimum VAS score ≥ 40 mm at screening visit.
- Women of childbearing potential and women with no menses for a period < 12 months must have a negative pregnancy test at Visit 0 and have to agree not to start a pregnancy from the signature of the informed consent up to the Final Visit/Visit 2, using an appropriate birth control method such as combined oestrogen-progestin containing hormonal contraceptives (e.g., oral, injectable, transdermal), progestin-only hormonal contraceptives (e.g., oral, injectable, implantable), intrauterine device (IUD) or Intrauterine hormone-releasing System (IUS) in combination with male condom, bilateral tubal occlusion, vasectomised partner, sexual abstinence. The following definitions will be considered:
- Patients legally capable of giving their consent to participate in the study and available to sign and date the written informed consent.
Key exclusion criteria (26 listed)
- Known hypersensitivity or allergy to the active ingredients and/or to any component of the study medications.
- Patients with rare hereditary problems of galactose intolerance, total lactase deficiency or glucose-galactose malabsorption
- Lactating and pregnant women.
- Clinically significant abnormalities on physical examination, vital signs or laboratory tests at Visit 0 which in the opinion of the Investigator could interfere with the study procedures or endpoints evaluation.
- Suspicious or confirmed COVID-19 infection at time of screening visit.
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 |
|---|---|---|
| TachifeneAlso: paracetamol 500 mg/ibuprofen 150 mgparacetamol 500 mg/ibuprofen 150 mg FDC, film-coated tablets. Two tablets 3 times daily for 3 days (i.e., every 8 hours ± 1 hour). | Drug | Tachifene |
| BrufenAlso: ibuprofen 600 mgibuprofen 600 mg, film coated tablets. One tablet 3 times daily for 3 days (i.e., every 8 hours ± 1 hour). | Drug | Brufen |
Primary outcome
The primary endpoint will be the area under the pain intensity difference-versus-time curve of Low Back Pain scores up to 3 days of treatment
Time frame: From Day 1 up to Day 3 (±1)
The pain intensity difference will be considered to be the difference in VAS pain intensity between one time-point and the baseline. The sum of the pain intensity differences (SPID) will be the sum of the average of two consecutive pain intensity differences multiplied by the time-interval between two time points.
7 secondary outcomes
Change in Visual Analogue Scale 0-10 cm (100 mm)
Time frame: Day 0 and Day 8 (±1)
Change from baseline up to the end of the study in Visual Analogue Scale 0-10 cm (100 mm) score.
Time frame: From Day 0 to Day 8 (±1)
Change from baseline up to the end of the study in the hand-to-floor distance
Time frame: Day 0, Day 4 and Day 8 (±1)
Change from baseline up to the end of the study in the in the degree of improvement in the functional disability
Time frame: Day 0, Day 4 and Day 8 (±1)
Change in the patients' global impression
Time frame: Day 4 and Day 8 (±1)
Change in the clinical global impression
Time frame: Day 4 and Day 8 (±1)
Monitoring the frequency of adverse events
Time frame: 8 (±1) days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
11 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Tachifene and Brufen in people with Low Back Pain, run by Aziende Chimiche Riunite Angelini Francesco S.p.A at 11 sites in 2 countries.
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 26 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 31 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Poland, 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. 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?
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?
The primary endpoint will be the area under the pain intensity difference-versus-time curve of Low Back Pain scores up to 3 days of treatment (time frame: From Day 1 up to Day 3 (±1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Jan 2023; AzTrials last refreshed its copy on 8 Nov 2026.