Trial | NCT00604539  Report issue

Title

Effect of Chondroitin Sulphate on Synovial Inflammation in Patients With Osteoarthritis of the Knee
Study of the Effect of Chondroitin Sulphate on Synovial Inflammation in Patients With Osteoarthritis of the Knee

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    chondroitin ...

  • Study Participants

    70
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.
Study Started
Feb 29
2008
Primary Completion
Nov 30
2009
Last Update
Dec 19
2011
Estimate

Drug Chondroitin sulphate (Condrosan)

800 mg (two capsules of 400 mg each) taken once a day for one year

Drug Placebo

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

1 Experimental

Chondroitin sulphate

2 Placebo Comparator

Criteria 

Inclusion Criteria:

Primary OA of the knee according to ACR with synovitis criteria (warmth, swelling or effusion);
OA of radiological stages 2 and 3 according to Kellgren-Lawrence;
Minimum joint space width ≥2 mm in the medial femorotibial compartment on standing knee X-ray;
VAS of pain while walking ≥40 mm.

Exclusion Criteria:

Known allergy to chondroitin sulphate;
Progressive or serious pathologies (cancer, AIDS,...);
Other bone and articular diseases (antecedents and/or current signs) such as chondrocalcinosis, Paget's disease, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, hemochromatosis, Wilson's disease, osteochondromatosis;
Corticosteroids (oral, injectable), indomethacin, therapeutic dose of glucosamine or chondroitin sulphate during the 12 weeks preceding inclusion;
Hyaluronic Acid (intra-articular pathway) during the 26 weeks preceding inclusion;
Radioactive synovectomy during the 12 weeks preceding inclusion;
If the patient is receiving NSAID at baseline (D0), it should be maintained at a stable dosage as much as possible from D0 to D180. In the open phase of the study (D180 to D360), NSAID will also be allowed as rescue medication along with acetaminophen.
No Results Posted