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Study of the Effect of Chondroitin Sulfate(CONDROSAN) on Structural Changes in Knee Osteoarthritis Patients Assessed by MRI

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Bioiberica
ClinicalTrials.gov Identifier:
NCT01354145
First received: May 13, 2011
Last updated: December 19, 2012
Last verified: December 2012
  Purpose

The main purpose of this study is to compare the cartilage volume loss of the lateral compartment (femoral condyle and tibial plateau) at the Baseline visit and after 24 months of treatment in patients treated with CHONDROITIN SULPHATE (CONDROSAN) 1200 mg daily vs. patients treated with CELECOXIB 200 mg daily.


Condition Intervention Phase
Knee Osteoarthritis
Drug: Chondroitin sulfate
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by Bioiberica:

Primary Outcome Measures:
  • To compare the cartilage volume loss of the lateral compartment (femoral condyle and tibial plateau) at the Baseline visit and after 24 months of treatment either with CHONDROITIN SULPHATE (CONDROSAN) 1200 mg daily or with CELECOXIB 200 mg daily [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • To compare the cartilage volume loss of the global knee and its sub regions including the medial compartment (femoral condyle and tibial plateau) at the Baseline visit and after 24 months. [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To compare the severity of synovitis, at the baseline visit and the follow-up visits in subjects treated either with CHONDROITIN SULPHATE (CONDROSAN) or CELECOXIB [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • To compare the bone marrow lesions in the global knee and the different sub regions at the baseline visit and the follow-up visits in subjects treated either with CHONDROITIN SULPHATE (CONDROSAN) or CELECOXIB [ Time Frame: 24 moths ] [ Designated as safety issue: No ]
  • Assessment by the subject of the pain experienced upon walking, measured by a horizontal Visual Analog Scale (VAS) of 100 mm [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Assessment of the WOMAC index, total WOMAC score as well as the subsets scores (pain, function and stiffness) [ Time Frame: 24 moths ] [ Designated as safety issue: No ]
  • Short Form (SF-36) Health Survey [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Assessment of the presence or absence of joint swelling and/or effusion [ Time Frame: 24 months ] [ Designated as safety issue: No ]
  • Use of acetaminophen [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 150
Study Start Date: June 2011
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Chondroitin sulfate (Condrosan) Drug: Chondroitin sulfate
Chondroitin sulphate 1200 mg/day vs Celecoxib 200 mg/day, 24 months treatment period
Active Comparator: Celecoxib Drug: Chondroitin sulfate
Chondroitin sulphate 1200 mg/day vs Celecoxib 200 mg/day, 24 months treatment period

  Eligibility

Ages Eligible for Study:   40 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Individuals of either sex, aged 40 years and more;
  • Subjects presenting primary OA of the knee according to ACR criteria with signs of synovitis (warmth, swelling or effusion;
  • Subjects with an OA of radiological stages 2 and 3 according to Kellgren-Lawrence;
  • Subjects with a Minimum joint space width ≥2 mm in the medial femorotibial compartment on standing knee X-ray;
  • Subjects with a VAS of pain while walking ≥ 40 mm.

Exclusion Criteria:

  • Subjects with known allergy to CHONDROITIN SULPHATE, hypersensitivity to CELECOXIB, demonstrated allergic-type reactions to sulphonamides, experienced asthma, urticaria or allergic-type reactions after taking sulphonamides, aspirin (acetyl salicylic acid [ASA]), lactose or NSAIDs;
  • Subjects with active malignancy of any type or history of a malignancy within the last five years other than basal cell carcinoma;
  • Subjects at increased risk for prostate cancer, with prostate cancer, or with a history of prostate cancer within the last five years;
  • Subjects with other bone and articular diseases (antecedents and/or current signs) such as chondrocalcinosis, Paget's disease of the ipsilateral limb to the target knee, rheumatoid arthritis, aseptic osteonecrosis, gout, septic arthritis, ochronosis, acromegaly, haemochromatosis, Wilson's disease, osteochondromatosis seronegative spondylo-arthropathy, mixed connective tissue disease, collagen vascular disease, psoriasis, inflammatory bowel disease;
  • Subjects with isolated knee lateral compartment OA defined by joint space loss in the lateral compartment only;
  • Subjects with Class IV functional capacity using the American Rheumatism Association criteria;
  • Subjects who have had surgery in any lower limb or arthroscopy, aspiration or lavage in any lower limb joint within 180 days of the Baseline Visit;
  • Subjects with a history of heart attack or stroke, or experienced serious chest pain related to heart disease, or who have had serious diseases of the heart such as congestive heart failure;
  • Subjects with high risk of CV events, according to the AHA assessment of CV risk tables;
  • Subjects with a history of recurrent UGI ulceration or active inflammatory bowel disease (e.g., Crohn's disease or ulcerative colitis), a significant coagulation defect, or any other condition, which in the investigator's opinion might preclude the chronic use of CELECOXIB. Subjects may, at the Investigator's discretion, take a PPI or antacids daily as required;
  • Subjects who have been diagnosed as having or have been treated for oesophageal, gastric, pyloric channel, or duodenal ulceration within 30 days prior to receiving the first dose of study medication;
  • Subjects using corticosteroids (oral, injectable; exception of intraarticular/soft tissue injection at the exclusion of the target knee), indomethacin, tramadol, codeine, empracet, therapeutic dose of glucosamine or CHONDROITIN SULPHATE during the 12 weeks preceding inclusion;
  • Subjects using hyaluronic acid (intra-articular target knee) during the 26 weeks preceding inclusion;
  • Subjects using Natural Health Products (e.g. capsaicin, boswellia, willow bark), and creams and analgesic gels (e.g. camphor and alcohol based gels) during one week preceding baseline;
  • Subjects using Natural Health Products susceptible to increase the risk of bleeding (e.g. garlic, dong quai, etc.) during one week preceding baseline;
  • Subjects receiving radioactive synovectomy (target knee) during the 12 weeks preceding inclusion;
  • Subjects who are receiving NSAID and do not want to stop during the study;
  • If treatment of osteoporosis (biphosphonates, SERMS, THS) is necessary, it will have to be continued, unmodified, for the entire duration of the study;
  • Subjects who have used medications with MMP-inhibitory properties (e.g. tetracycline or structurally related compounds) within 28 days prior to the Baseline Visit;
  • Subjects who are taking lithium carbonate, phenytoin or anticoagulants (with the exception of ASA up to a maximum daily dose of 325 mg);
  • Subjects who have received chondrocyte transplants in any lower extremity joint;
  • Subjects who use oral or topical COXIBs;
  • Subjects who use calcitonin;
  • Subjects who use immunosuppressive drugs.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01354145

Locations
Canada, Quebec
CRC
Montreal, Quebec, Canada, J1H-5N4
Institut de Rhumatologie de Montréal
Montréal, Quebec, Canada, H2L-1S6
Groupe de Recherche en rhumatologie et maladies osseoues
Québec, Quebec, Canada, G1V-3M7
Centre de Rhumatologie St. Louis
Sante Foi, Quebec, Canada, G1W-4R4
Centre de Recherche musculo-squellettique
Trois-Rivières, Quebec, Canada, G8A-1Y2
Sponsors and Collaborators
Bioiberica
  More Information

No publications provided

Responsible Party: Bioiberica
ClinicalTrials.gov Identifier: NCT01354145     History of Changes
Other Study ID Numbers: CS/III-DMOAD-02
Study First Received: May 13, 2011
Last Updated: December 19, 2012
Health Authority: Canada: Health Canada

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases

ClinicalTrials.gov processed this record on November 24, 2014