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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00604539
First Posted: January 30, 2008
Last Update Posted: December 19, 2011
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Bioiberica
  Purpose
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.

Condition Intervention Phase
Synovitis Osteoarthritis Joint Diseases Muskuloskeletal Diseases Drug: Chondroitin sulphate (Condrosan) Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Study of the Effect of Chondroitin Sulphate on Synovial Inflammation in Patients With Osteoarthritis of the Knee

Resource links provided by NLM:


Further study details as provided by Bioiberica:

Primary Outcome Measures:
  • 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 Outcome Measures:
  • 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 ]

Estimated Enrollment: 70
Study Start Date: February 2008
Primary Completion Date: November 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Chondroitin sulphate
Drug: Chondroitin sulphate (Condrosan)
800 mg (two capsules of 400 mg each) taken once a day for one year
Placebo Comparator: 2 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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00604539


Locations
Canada, Quebec
Inst. De Rhumatologie
Montréal, Quebec, Canada, H2L 1S6
Groupe de recherche en rhumatologie et maladies osseuses
Ste-Foy, Quebec, Canada, G1V 3M7
Centre de rhumatologie St-Louis
Ste-Foy, Quebec, Canada, G1W 4R4
Centre de recherche musculo-squelettique
Trois-Rivieres, Quebec, Canada, G8A 1Y2
Sponsors and Collaborators
Bioiberica
Investigators
Principal Investigator: Jean-Pierre Pelletier, Prof., Dr. ArthroLab Inc.
Principal Investigator: Johanne Martel-Pelletier, Prof., Dr. ArthroLab Inc.
  More Information

Publications:

Responsible Party: Dr. Josep Vergés, Scientific Medical Director, Bioibérica S.A.
ClinicalTrials.gov Identifier: NCT00604539     History of Changes
Other Study ID Numbers: CS/IV-SIN-01
First Submitted: January 17, 2008
First Posted: January 30, 2008
Last Update Posted: December 19, 2011
Last Verified: December 2011

Keywords provided by Bioiberica:
Chondroitin sulphate
Synovitis
Knee osteoarthritis
Magnetic Resonance Imaging

Additional relevant MeSH terms:
Osteoarthritis
Inflammation
Osteoarthritis, Knee
Joint Diseases
Synovitis
Arthritis
Musculoskeletal Diseases
Rheumatic Diseases
Pathologic Processes