Study of the Effect of Chondroitin Sulfate on Structural Changes in Knee Osteoarthritis Patients Assessed by MRI
Condition: Knee Osteoarthritis
MeSH terms: Osteoarthritis; Osteoarthritis, Knee
Intervention: Chondroitin sulfate; Celecoxib
Intervention description: Chondroitin sulphate 1200 mg/day, 24 months treatment period; Celecoxib 200 mg/day, 24 months treatment period
Intervention MeSH terms: Celecoxib
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 194.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      The main purpose of this study is to compare the cartilage volume loss 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.
    

Eligibility 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

          -  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