This trial is active, not recruiting.

Condition knee osteoarthritis
Treatments chondroitin sulfate, celecoxib, placebo
Phase phase 3
Sponsor IBSA Institut Biochimique SA
Start date June 2014
End date November 2015
Trial size 600 participants
Trial identifier NCT02079727, 12EU/Ct06, 2013-001619-62


The purpose of this study is to confirm the efficacy and safety of 800 mg Chondroitin 4&6 sulfate (Condrosulf) vs placebo once a day for 6 months in the symptomatic treatment of knee osteoarthritis. A third group, Celecoxib 200 mg (Celebrex) once a day, will be used as active comparator.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
1 tablet of Condrosulf 800 mg and 1 capsule of placebo of Celebrex once a day for 182 days
chondroitin sulfate Condrosulf
(Placebo Comparator)
1 tablet of PBO of Condrosulf and 1 capsule of PBO of Celebrex, once a day for 182 days
placebo placebo for chondroitin sulfate and placebo for celecoxib
(Active Comparator)
1 capsule of 200 mg of Celebrex and 1 tablet of 800 mg placebo of Condrosulf once a day for 182 days
celecoxib Celebrex

Primary Outcomes

Lequesne's Index
time frame: Day 1 and Day 182
Pain (VAS in mm)
time frame: Day 1 and Day 182

Secondary Outcomes

Lequesne's Index
time frame: Day 1, 30, 90 and 182
Pain (VAS in mm)
time frame: Day 1, 30, 91 and 182
MCII (minimal clinically important improvement)
time frame: Day 1, 30, 91 and 182
PASS (patient acceptable symptom state)
time frame: Day 1, 30, 91 and 182
Consumption of Paracetamol
time frame: Day 1, 30, 91 and 182
Global efficacy assessment
time frame: At Day 30, 91 and 182
Number of adverse events related to the treatments
time frame: At Day 30, 91 and 182
Number of drop-outs due to AE (adverse event) related to the treatment
time frame: At Day 30, 91 and 182

Eligibility Criteria

Male or female participants at least 50 years old.

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 - Kellgren & Lawrence grade I-III - 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's index for the knee osteoarthritis - Assessing pain on Huskisson's VAS ≥ 50 mm - 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 - Women having negative pregnancy test - Patients able to understand and follow the study protocol - Patients who have signed the written informed consent for their participation in the clinical trial Exclusion Criteria: - With a history of heart attack, ischemic heart disease or cerebrovascular disease (including transient ischemic attacks) - Having or have had peripheral arterial disease or past surgery orf peripheral arteries - With a history or currently significat coagulation defect or/and blood dyscrasia - With high risk of cardiovascular events - With any acute or chronic infections requiring antimicrobial therapy or serious viral (e.g., hepatitis, HIV positivity) or fungal infections - With a history of recurrent gastrointestinal ulceration or active inflammatory bowel diseases (e.g., Crohn's disease or ulcerative colitis) - Having 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 - Having severe liver or kidney disease - With allergy to Celebrex or any of the other ingredients of Celebrex - Having had an allergic reaction to sulphonamides - Having had, as a result of intake of acetylsalicylic acid or other NSAIDs, asthma, nose polyps, severe nose congestion, or an allergic reaction such as itchy skin rash, swelling of the face, lips, tongue or throat, breathing difficulties or wheezing - Presenting lactose intolerance - Mild or not symptomatic knee osteoarthritis : < 7 of Lequesne's index, - Pain on Huskisson's VAS (Visual Analogic Scale) < 50 mm - Predominantly femoro-patellar osteoarthritis - Destructive osteoarthritis of the knee justifying a surgery in the following 6 months - Osteoarthritis with hydrarthrosis requiring a puncture or an infiltration - Important genu varum or valgus >8° (physiological angle including) - Kellgren & Lawrence grade IV - 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, symptomatic slow acting drugs for osteoarthrithis (chondroitin sulphates, glucosamine sulphates, diacerhein, hyaluronic acid and food supplement for joint care) in the last 3 months; treatment with corticoids, by any administration route during the last month; any medication having an influence on pain: - NSAIDs (nonsteroidal anti-inflammatory drugs) 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 psychiatric illness hindering the protocol complaince, alcoholism, ongoing or < 1 year drug dependency - Pregnant or likely to become it during clinical trial or lactating - Women having positive pregnancy test - Having participated in other clinical trials in the month preceding the clinical trial.

Additional Information

Official title A Multicentre, Comparative, Randomised, Double-blind, Double-dummy Clinical Trial on the Efficacy and Safety of Condrosulf Versus Celebrex and Versus a Placebo in the Treatment of Knee Osteoarthritis
Principal investigator Jean-Yves Reginster, Prof. MD PhD
Trial information was received from ClinicalTrials.gov and was last updated in February 2016.
Information provided to ClinicalTrials.gov by IBSA Institut Biochimique SA.