A Phase 2 Study to Assess the Efficacy and Safety of CMX-020 in Treating Osteoarthritis.
- Conditions
- osteoarthritisMusculoskeletal - Osteoarthritis
- Registration Number
- ACTRN12616001435471
- Lead Sponsor
- Cytometix A
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 90
(1) Has satisfied the criteria of the American College of Rheumatology for a diagnosis of primary OA of the knee;
(2) Has a Functional Class of I, II, or III;
(3) Has satisfied the criteria of an OA flare;
(4) Has satisfied the criteria for a placebo non-responder”;
(5) If female is of non-childbearing potential, or is either practicing abstinence or using a medically acceptable form of contraception or double-barrier, is not lactating and has had a negative urine pregnancy test at Visit 1 and Visit 3;
(6) If male must agree to use a condom if engaging in sexual intercourse at any time during the duration of the study.
(1) Has received oral, intramuscular, intra-articular or soft tissue injection of a corticosteroid within four weeks prior to enrollment into the study;
(2) NSAID or analgesic use within 5 days prior to Visit 3 (Baseline) assessment;
(3) Has a diagnosis of any inflammatory arthritis, gout, or acute trauma of the knee;
(4) Has an active GI tract, renal, hepatic, or a coagulation disorder;
(5) Has known hypersensitivity to analgesics, NSAIDs, celecoxib, COX-2 inhibitors, sulphonamides, acetaminophen (paracematol), or CMX-020.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The primary measure of efficacy is the change between Day 10 and Baseline of the Treatment Period in the VAS measure of pain.[The self reported assessment will be performed by the subject at Screening (Visit 1), immediately prior to commencement of Treatment Period 1 (Visit 2), 7 days post commencement of Treatment Period 1 (Visit 3) and 10 days post commencement of Treatment Period 2 (Visit 4).]
- Secondary Outcome Measures
Name Time Method