E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
Primary femorotibial osteoarthritis of the knee with mechanical knee pain |
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E.1.1.1 | Medical condition in easily understood language |
Knee pain due to osteoarthritis |
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E.1.1.2 | Therapeutic area | Diseases [C] - Musculoskeletal Diseases [C05] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 14.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10023476 |
E.1.2 | Term | Knee osteoarthritis |
E.1.2 | System Organ Class | 10028395 - Musculoskeletal and connective tissue disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
To demonstrate the superiority of the efficacy of ibuprofen with codeine (Antarène® codeine) compared to ibuprofen alone (Antarène®) in the treatment of acute episodes of osteoarthritis of the knee at 4 days. |
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E.2.2 | Secondary objectives of the trial |
To compare the efficacy of ibuprofen with codeine (Antarène® codeine) to ibuprofen alone (Antarène®) in the treatment of acute episodes of osteoarthritis of the knee at 7 days.
To compare quality of life at 7 days as evaluated by the SF-12 questionnaire.
To compare the tolerability of both medicinal products at 4 days and 7 days.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
Male or female participants between the ages of 40 and 80 years.
Participant with symptomatic femorotibial osteoarthritis of the knee.
Participant who does not require a puncture for hydarthrosis.
Participant with primary femorotibial osteoarthritis of the knee who meets the criteria of the ACR:
Mechanical knee pain and at least one of the 3 following criteria:
1. Age ≥ 50 years
2. Stiffness in the morning < 30 minutes
3. Cracking of the knee during active movement
and osteophytes on the X-rays.
Participant whose arthritis has been identified radiologically: pinching of the joint interline and osteophyte on the images that are less than 1 year old.
Symptomatic patient, in one side only, with a VAS pain scale score of ≥ 50 mm, or if the patient has bilateral knee osteoarthritis, evaluation of the more painful side.
Participant with pain for at least 15 days during the month before inclusion.
Participant taking no analgesics or NSAIDs for at least 2 to 5 days depending on the NSAID, with the exception of the paracetamol allowed up to 12 hours before inclusion
Participant with health insurance.
Participant able to understand and follow the study instructions.
Participant who has signed an informed consent form.
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E.4 | Principal exclusion criteria |
Participant with respiratory insufficiently whatever is the degree of severity.
Participant with non-symptomatic or insufficiently symptomatic osteoarthritis of the knee.
Osteoarthritis of the knee secondary to trauma.
Participant with symptomatic homolateral osteoarthritis of the hip.
Varus or valgus deformity of the knee being tested (deformation axis ≥ 15° on the x-rays).
Very significant hydarthrosis (to be punctured) at the time of inclusion.
Patient with inflammatory rheumatism (PR, psoriatic rheumatism, articular chondrocalcinosis, gout, Paget’s disease, ankylosing spondylitis, lupus, etc.).
History of trauma in the osteoarthritic knee within the 6 months before inclusion.
Crural or sciatic radiculalgia of the lower limb.
Tendinopathy (peri-arthritis of the hip).
Subject who has received an intra-articular injection of corticosteroids in the selected knee within the 2 months before inclusion.
Subject who received an intra-articular injection of hyaluronic acid in the selected knee within 1 month of inclusion.
Subject receiving treatment with SAAA for less than 3 months at the time of inclusion or whose treatment is not stable during the 3 months before inclusion.
Ongoing anticoagulant treatment with heparin, warfarin or analgesic (platelet anti-aggregants such as aspirin ≤ 325 mg/d, ticlopidine (TICLID®) or clopidogrel (PLAVIX®) are allowed.
Implantation of a total knee replacement in the knee to be tested.
Participant with a severe condition that could interfere with the evaluation, such as: neoplasia, malignant haemopathy, kidney disease, liver disease or severe infection.
Subject participating in another trial.
Pregnant women or women who could become pregnant during the trial, or breast-feeding women.
Participant with intolerance to ibuprofen or codeine.
Participant a contraindication to NSAIDs:
- History of allergy or asthma triggered by use of ibuprofen or substances with similar activity such as other NSAIDs or aspirin.
- History of allergy to other ingredients of the Antarène® tablet.
- Active peptic ulcer.
- Severe hepatocellular insufficiency.
- Severe renal insufficiency.
- Severe uncontrolled cardiac insufficiency.
- Systemic lupus erythematosus.
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E.5 End points |
E.5.1 | Primary end point(s) |
Efficacy:
The principal criterion is: Reduction in the pain intensity as evaluated by a visual analogue scale.
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
Reduction in the pain intensity as evaluated by a visual analogue scale.
Quality of life
Tolerance |
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | Yes |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | Yes |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 2 |
E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 50 |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 80 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 10 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 10 |
E.8.9.2 | In all countries concerned by the trial days | 0 |