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OpenTrials
Completed

NCT Number: NCT00604539

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

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.

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Key information

Age range

40 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Inst. De Rhumatologie, Montreal, Quebec, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Chondroitin sulphate (Condrosan)

Drug

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

Placebo

Drug

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

Primary outcomes

  1. 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

Secondary outcomes

  1. Changes of cartilage volume and subchondral bone lesions

    Time frame: One year

  2. Pain measured by VAS

    Time frame: One year

  3. WOMAC index

    Time frame: One year

  4. SF-36 Health Questionaire

    Time frame: One year

  5. Assessment of joint swelling, effusion

    Time frame: One year

  6. Use of rescue medication

    Time frame: One year

  7. Tolerability

    Time frame: One year

  8. Adverse events

    Time frame: One year

Sponsors and collaborators

Lead sponsor

Bioiberica

Industry

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
First posted
Jan 30, 2008
Registry last updated
Dec 19, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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