ACTRN12616001435471
Recruiting
Not Applicable
A Phase 2 Study to Assess the Efficacy and Safety of CMX-020 in Treating Osteoarthritis.
Cytometix A0 sites90 target enrollmentOctober 14, 2016
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- Cytometix A
- Enrollment
- 90
- Status
- Recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •(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.
Exclusion Criteria
- •(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\.
Outcomes
Primary Outcomes
Not specified
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