A Phase 3 interventional study of chondroitin sulfate and celecoxib in Knee Osteoarthritis, sponsored by IBSA Institut Biochimique SA. Completed at 16 sites in 5 countries. Open to participants aged 50 Years and older. Per ClinicalTrials.gov, last updated 2017-03-03.
Sponsored by IBSA Institut Biochimique SA · Phase 3, Interventional, and Treatment
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.
4,398 studies on the registry are indexed under Osteoarthritis; 582 are open to participants now.
This study's enrollment of 604 is above the median of 70 across 3,440 interventional studies indexed under Osteoarthritis.
Browse Osteoarthritis studies →IBSA Institut Biochimique SA is the lead sponsor of 33 studies on the registry; 1 is open to participants now.
Of its 5 completed or terminated interventional studies of FDA-regulated products, 3 (60%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
1 tablet of Condrosulf 800 mg and 1 capsule of placebo of Celebrex once a day for 182 days
Drug: chondroitin sulfate
1 tablet of PBO of Condrosulf and 1 capsule of PBO of Celebrex, once a day for 182 days
Drug: placebo
1 capsule of 200 mg of Celebrex and 1 tablet of 800 mg placebo of Condrosulf once a day for 182 days
Drug: celecoxib
Also known as: Condrosulf
Also known as: Celebrex
Also known as: placebo for chondroitin sulfate and placebo for celecoxib
Lequesne's Index
Decrease in the scores of the Lequesne's Index from Day 1 to Day 182.
Time frame: Day 1 and Day 182
Pain (VAS in mm)
Decrease in the VAS (pain in mm) from Day 1 to Day 182
Time frame: Day 1 and Day 182
Lequesne's Index
Evolution from Day 1 to Day 30, Day 90 and Day 182
Time frame: Day 1, 30, 90 and 182
Pain (VAS in mm)
Evolution of the pain on VAS (in mm) from Day 1 to Day 30, Day 91 and Day 182
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
Global efficacy assessed by the patient and the Investigator by means of a semi-quantitative verbal scale.
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
Treatment compliance
Time frame: Day 1, 30, 91 and 182
This study is completed, as verified in Mar 2017. You cannot join it, but the record below documents what was studied.
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IBSA Institut Biochimique SA