A study to evaluate the efficacy and safety of Condrosulf® versus Celebrex® and versus a placebo in the treatment of knee osteoarthritis

Conditions: knee osteoarthritis, the most common form of arthritis and a leading cause of morbidity and disability
MedDRA version: 18.0Level: LLTClassification code 10023476Term: Knee osteoarthritisSystem Organ Class: 100000004859
Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]

Registration Number: EUCTR2013-001619-62-PL

Lead Sponsor: IBSA, Institut Biochimique S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 600

Inclusion Criteria

Outpatients of either sex, aged = 50 years
Patients affected by primary knee osteoarthritis of the medial or lateral femoro-tibial compartment
Diagnosis according to the American College of Rheumatology (ACR) criteria
Knee osteoarthritis evolving for more than 6 months
Patients suffering from regular pain and functional disorders from at least 3 months
Accomplishing a score = 7 of Lequesne index for the knee osteoarthritis
Assessing pain on Huskisson’s VAS = 50mm
With radiography dated less than six months showing a remaining articular joint space
Without such an axial disorder to justify an osteotomy
Women taking contraceptive measures if not in menopause
Patients able to understand and follow the study protocol
Patients who have signed the written informed consent for their participation in the clinical trial

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 200

Exclusion Criteria

Mild or not symptomatic knee osteoarthritis : < 7 of Lequesne index,
or pain on Huskisson’s VAS (Visual Analogic Scale) < 50mm
Predominantly femoro-patellar osteoarthritis
Destructive osteoarthritis of the knee justifying a surgery in the following 6 months
Osteoarthritis with hydarthrosis requiring a puncture or an infiltration
Important genu varum or valgum > 8° (physiological angle including)
Knee joint surgery in the last 3 months (e.g. chondroscopy, arthroscopy)
Viscosupplementation, tidal lavage in the last 6 months
Arthritis and metabolic arthropathies, Paget’s illness
Having consumed:
basic treatment of arthritis with SYSADOA (chondroitin sulphates, glucosamine sulphates, diacerrhein, hyaluronic acid) in the last 3 months
treatment with corticoids, by any administration route during the last month
any medication having an influence on pain:
NSAIDs in the 5 days preceding the inclusion (wash out period considering 5 half-lives of the drug)
hypnotics, muscle relaxants, anxiolytics, if the intake has started less than 8 days before inclusion
paracetamol in the 10 hours preceding the inclusion
Foreseen physiotherapy, re-education, alternative medicine (mesotherapy, acupuncture) in the next six months (study period)
Presenting:
serious organic diseases as renal or hepatic insufficiency or blood dyscrasia
psychiatric illness hindering the protocol compliance, alcoholism, ongoing or < 1 year drug dependency
Patients with a history of heart attack or stroke, or who have experienced chest pain related to heart disease, or who have had serious disease of the heart
Patients with high risk of CV events
Patients with any acute or chronic infections requiring antimicrobial therapy or serious viral (e.g., hepatitis, HIV positivity) or fungal infections
Patients with a history of recurrent GI ulceration or active inflammatory bowel diseases (e.g., Crohn’s disease or ulcerative colitis), or a significant coagulation defect
Patients who have been diagnosed as having or have been treated for oesophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication.
Patients presenting lactose intolerance
Pregnant or likely to become it during clinical trial or lactating
Having participated in other clinical trials in the month preceding the clinical trial

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: assess the superiority of Condrosulf 800 mg once daily versus placebo for 182 days. Celebrex will be used as active control. The primary endpoints will be a change in the Lequesne algo-functional index and a change in the VAS from day 1 to day 182;Secondary Objective: evolution of the Lequesne algo-functional index from day 1 to day 30, 91 and 182. Evolution of the pain on VAS from day 1 to day 30, 91 and 182. Assessment of the MCII and of the PAS. Consumption of paracetamol. Global efficacy assessment. Number of adverse events related to the treatment. Number of drop-outs for intolerance. Treatment compliance. Biochemical markers assessment.;Primary end point(s): assess the superiority of Condrosulf 800 mg once daily versus placebo for 182 days. Celebrex will be used as active control. The primary endpoints will be a change in the Lequesne algo-functional index and a change in the VAS from day 1 to day 182;Timepoint(s) of evaluation of this end point: day 1 and day 182

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): evolution of the Lequesne algo-functional index from day 1 to day 30, 91 and 182. Evolution of the pain on VAS from day 1 to day 30, 91 and 182. Assessment of the MCII and of the PAS. Consumption of paracetamol. Global efficacy assessment. Number of adverse events related to the treatment. Number of drop-outs for intolerance. Treatment compliance. Biochemical markers assessment.;Timepoint(s) of evaluation of this end point: day 1, day 30, day 91, day 182

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