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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bioiberica
ClinicalTrials.gov Identifier:
NCT01354145
First received: May 13, 2011
Last updated: July 20, 2015
Last verified: July 2015

May 13, 2011
July 20, 2015
June 2011
September 2014   (final data collection date for primary outcome measure)
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 ]
Same as current
Complete list of historical versions of study NCT01354145 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Study of the Effect of Chondroitin Sulfate on Structural Changes in Knee Osteoarthritis Patients Assessed by MRI
Twenty-four Month Exploratory Study of the Effect of Chondroitin Sulphate on Structural Changes in Knee Osteoarthritis Patients as Assessed by MRI

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.

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 1200 mg daily vs. patients treated with CELECOXIB 200 mg daily.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Knee Osteoarthritis
  • Drug: Chondroitin sulfate
    Chondroitin sulphate 1200 mg/day, 24 months treatment period
    Other Name: Condrosan
  • Drug: Celecoxib
    Celecoxib 200 mg/day, 24 months treatment period
    Other Name: Celecoxib
  • Experimental: Chondroitin sulfate (Condrosan)
    CHONDROITIN SULPHATE Group: 1200 mg (three capsules of 400 mg each) taken once a day in the morning
    Intervention: Drug: Chondroitin sulfate
  • Active Comparator: Celecoxib
    CELECOXIB Group: 200 mg (one capsule of 200 mg CELECOXIB + two placebo capsules) taken in the morning
    Intervention: Drug: Celecoxib
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
196
October 2014
September 2014   (final data collection date for primary outcome measure)

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
  • 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, 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
  • Active malignancy of any type or history of a malignancy within the last five years other than basal cell carcinoma
  • 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
  • Isolated knee lateral compartment OA defined by joint space loss in the lateral compartment only
  • Class IV functional capacity using the American Rheumatism Association criteria
  • Have had surgery in any lower limb or arthroscopy, aspiration or lavage in any lower limb joint within 180 days of the Baseline Visit
  • 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
  • High risk of CV events, according to the AHA assessment of CV risk tables
  • 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
  • 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
  • Using hyaluronic acid (intra-articular target knee) during the 26 weeks preceding inclusion
  • 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;
  • Using Natural Health Products susceptible to increase the risk of bleeding (e.g. garlic, dong quai, etc.) during one week preceding baseline;
  • 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
  • Have used medications with MMP-inhibitory properties (e.g. tetracycline or structurally related compounds) within 28 days prior to the Baseline Visit
  • Are taking lithium carbonate, phenytoin or anticoagulants (with the exception of ASA up to a maximum daily dose of 325 mg)
  • Have received chondrocyte transplants in any lower extremity joint
  • Use oral or topical COXIBs, calcitonin or immunosuppressive drugs
Both
40 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT01354145
CS/III-DMOAD-02
Yes
Bioiberica
Bioiberica
Not Provided
Study Chair: Jean-Pierre Pelletier, MD Principal Author
Bioiberica
July 2015

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP