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

Phase 3

Completed

• Conditions: Synovitis; Osteoarthritis; Joint Diseases; Muskuloskeletal Diseases
• Interventions: Drug: Chondroitin sulphate (Condrosan); Drug: Placebo

• Registration Number: NCT00604539
• Lead Sponsor: Bioiberica

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-01-17
• Study First Submitted QC: 2008-01-29
• Study First Posted: 2008-01-30
• Study Start: 2008-02
• Primary Completion: 2009-11
• Status Verified: 2011-12
• Last Update Submitted: 2011-12-16
• Last Update Posted: 2011-12-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Chondroitin sulphate (Condrosan)	Chondroitin sulphate
2	Placebo	-

Primary Outcome Measures

Name	Time	Method
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	One year

Secondary Outcome Measures

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

Trial Locations

Locations (4)

Centre de recherche musculo-squelettique; 🇨🇦 Trois-Rivieres, Quebec, Canada

Centre de rhumatologie St-Louis; 🇨🇦 Ste-Foy, Quebec, Canada

Groupe de recherche en rhumatologie et maladies osseuses; 🇨🇦 Ste-Foy, Quebec, Canada

Inst. De Rhumatologie; 🇨🇦 Montréal, Quebec, Canada