A Phase 3 interventional study of Chondroitin sulphate (Condrosan) and Placebo in Synovitis, Osteoarthritis and Joint Diseases, sponsored by Bioiberica. Completed at 4 sites in Canada. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2011-12-19.
Sponsored by Bioiberica · Phase 3, Interventional, and Treatment
The purpose of this study is to determine the effect of a chondroitin sulphate conventional treatment on the degree of severity of synovitis, as measured by magnetic resonance in patients with knee OA with clinical synovitis.
53 studies on the registry are indexed under Synovitis; 12 are open to participants now.
This study's planned enrollment of 70 is close to the median of 70 across 29 interventional studies indexed under Synovitis.
Browse Synovitis studies →Bioiberica is the lead sponsor of 16 studies on the registry; 2 are open to participants now.
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Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Chondroitin sulphate
Drug: Chondroitin sulphate (Condrosan)
Drug: Placebo
800 mg (two capsules of 400 mg each) taken once a day for one year
Two placebo capsules taken once a day for six months followed by an additional six month treatment of 800 mg (two capsules of 400 mg of Chondroitin sulphate each) taken once a day
Evaluation of the change in the severity of synovitis measured by MRI according to the modified methods of Loeuille et al. after chondroitin sulphate treatment in patients with knee OA and clinical signs of synovitis
Time frame: One year
Changes of cartilage volume and subchondral bone lesions
Time frame: One year
Pain measured by VAS
Time frame: One year
WOMAC index
Time frame: One year
SF-36 Health Questionaire
Time frame: One year
Assessment of joint swelling, effusion
Time frame: One year
Use of rescue medication
Time frame: One year
Tolerability
Time frame: One year
Adverse events
Time frame: One year
This study is completed, as verified in Dec 2011. You cannot join it, but the record below documents what was studied.
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