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

December 16, 2011 updated by: Bioiberica

Study of the 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

70

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montréal, Quebec, Canada, H2L 1S6
        • Inst. De Rhumatologie
      • Ste-Foy, Quebec, Canada, G1V 3M7
        • Groupe de Recherche en Rhumatologie et Maladies Osseuses
      • Ste-Foy, Quebec, Canada, G1W 4R4
        • Centre de Rhumatologie St-Louis
      • Trois-Rivieres, Quebec, Canada, G8A 1Y2
        • Centre De Recherche Musculo-Squelettique

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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
Experimental: 1
Chondroitin sulphate
Drug: Chondroitin sulphate (Condrosan)
800 mg (two capsules of 400 mg each) taken once a day for one year

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
One year

Secondary Outcome Measures

Outcome Measure
Time Frame
Adverse events
Time Frame: One year
One year
Changes of cartilage volume and subchondral bone lesions
Time Frame: One year
One year
Pain measured by VAS
Time Frame: One year
One year
WOMAC index
Time Frame: One year
One year
SF-36 Health Questionaire
Time Frame: One year
One year
Assessment of joint swelling, effusion
Time Frame: One year
One year
Use of rescue medication
Time Frame: One year
One year
Tolerability
Time Frame: One year
One year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bioiberica

Investigators

  • Principal Investigator: Jean-Pierre Pelletier, Prof., Dr., ArthroLab Inc.
  • Principal Investigator: Johanne Martel-Pelletier, Prof., Dr., ArthroLab Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2008

Primary Completion (Actual)

November 1, 2009

Study Completion

December 7, 2022

Study Registration Dates

First Submitted

January 17, 2008

First Submitted That Met QC Criteria

January 29, 2008

First Posted (Estimate)

January 30, 2008

Study Record Updates

Last Update Posted (Estimate)

December 19, 2011

Last Update Submitted That Met QC Criteria

December 16, 2011

Last Verified

December 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS/IV-SIN-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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