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

Primary Purpose

Synovitis, Osteoarthritis, Joint Diseases

Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
Chondroitin sulphate (Condrosan)
Placebo
Sponsored by
Bioiberica
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Synovitis focused on measuring Chondroitin sulphate, Synovitis, Knee osteoarthritis, Magnetic Resonance Imaging

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Inst. De Rhumatologie
  • Groupe de recherche en rhumatologie et maladies osseuses
  • Centre de rhumatologie St-Louis
  • Centre de recherche musculo-squelettique

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

1

2

Arm Description

Chondroitin sulphate

Outcomes

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

Secondary Outcome Measures

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

Full Information

First Posted
January 17, 2008
Last Updated
December 16, 2011
Sponsor
Bioiberica
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1. Study Identification

Unique Protocol Identification Number
NCT00604539
Brief Title
Effect of Chondroitin Sulphate on Synovial Inflammation in Patients With Osteoarthritis of the Knee
Official Title
Study of the Effect of Chondroitin Sulphate on Synovial Inflammation in Patients With Osteoarthritis of the Knee
Study Type
Interventional

2. Study Status

Record Verification Date
December 2011
Overall Recruitment Status
Completed
Study Start Date
February 2008 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Bioiberica

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Synovitis, Osteoarthritis, Joint Diseases, Muskuloskeletal Diseases
Keywords
Chondroitin sulphate, Synovitis, Knee osteoarthritis, Magnetic Resonance Imaging

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
70 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Chondroitin sulphate
Arm Title
2
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Chondroitin sulphate (Condrosan)
Intervention Description
800 mg (two capsules of 400 mg each) taken once a day for one year
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
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 Outcome Measure Information:
Title
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 Measure Information:
Title
Changes of cartilage volume and subchondral bone lesions
Time Frame
One year
Title
Pain measured by VAS
Time Frame
One year
Title
WOMAC index
Time Frame
One year
Title
SF-36 Health Questionaire
Time Frame
One year
Title
Assessment of joint swelling, effusion
Time Frame
One year
Title
Use of rescue medication
Time Frame
One year
Title
Tolerability
Time Frame
One year
Title
Adverse events
Time Frame
One year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean-Pierre Pelletier, Prof., Dr.
Organizational Affiliation
ArthroLab Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Johanne Martel-Pelletier, Prof., Dr.
Organizational Affiliation
ArthroLab Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Inst. De Rhumatologie
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H2L 1S6
Country
Canada
Facility Name
Groupe de recherche en rhumatologie et maladies osseuses
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1V 3M7
Country
Canada
Facility Name
Centre de rhumatologie St-Louis
City
Ste-Foy
State/Province
Quebec
ZIP/Postal Code
G1W 4R4
Country
Canada
Facility Name
Centre de recherche musculo-squelettique
City
Trois-Rivieres
State/Province
Quebec
ZIP/Postal Code
G8A 1Y2
Country
Canada

12. IPD Sharing Statement

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15374855
Citation
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Citation
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Results Reference
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Effect of Chondroitin Sulphate on Synovial Inflammation in Patients With Osteoarthritis of the Knee

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