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

This study has been completed.
Sponsor:
Information provided by:
Bioiberica
ClinicalTrials.gov Identifier:
NCT00604539
First received: January 17, 2008
Last updated: December 16, 2011
Last verified: December 2011
History of Changes
  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 Blind (Subject, 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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Changes of cartilage volume and subchondral bone lesions [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Pain measured by VAS [ Time Frame: One year ] [ Designated as safety issue: No ]
  • WOMAC index [ Time Frame: One year ] [ Designated as safety issue: No ]
  • SF-36 Health Questionaire [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Assessment of joint swelling, effusion [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Use of rescue medication [ Time Frame: One year ] [ Designated as safety issue: No ]
  • Tolerability [ Time Frame: One year ] [ Designated as safety issue: Yes ]
  • Adverse events [ Time Frame: One year ] [ Designated as safety issue: Yes ]

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

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00604539

Locations
Canada, Quebec
Inst. De Rhumatologie
Montréal, Quebec, Canada, H2L 1S6
Centre de rhumatologie St-Louis
Ste-Foy, Quebec, Canada, G1W 4R4
Groupe de recherche en rhumatologie et maladies osseuses
Ste-Foy, Quebec, Canada, G1V 3M7
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, CS/IV-SIN-01
Study First Received: January 17, 2008
Last Updated: December 16, 2011
Health Authority: Canada: Health Canada

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

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

ClinicalTrials.gov processed this record on June 18, 2013