Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study In Subjects With Osteoarthritic Pain … (NCT00689273) | Clinical Trial Compass
CompletedPhase 2
Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study In Subjects With Osteoarthritic Pain Of The Knee
United States159 participantsStarted 2008-08-05
Plain-language summary
To evaluate the efficacy, safety, tolerability, pharmacodynamics, and pharmacokinetics in patients with osteoarthritic pain of the knee. The most painful knee joint will be identified as the index joint at screening, and this joint will be used for all pain assessments throughout the study.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion Criteria:
* Male or female of any race, between the ages of 18 and 75 years inclusive
* Female subjects must be of non-childbearing potential and have a negative pregnancy test at Screening.
* Osteoarthritis of the knee of at least 6 months duration and meeting the American College of Rheumatology Criteria. For radiographic criteria the Xray must have been taken within the last 5 years. If none is available, one should be taken and the diagnostic criteria confirmed prior to randomization.
* Willing and able to discontinue all current analgesic therapy, including OTC pain medications and topical analgesics for OA pain, for period beginning with washout phase (lasting 2 days or 5 half-lives of patient's current analgesic medication prior to Day -6) and continuing for the entire duration of study. As an exception, acetaminophen may be used for non-joint related pain at doses ≤1 g/day at the discretion of a qualified member of the study team.
* If a subject has evidence or a history of clinically significant endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, renal, psychiatric, or neurological disease, the investigator must confirm that the disease is stable (at least 4 weeks) and under control.
* QTc interval ≤450 msec and a PR interval ≤210 msec on Screening ECG.
Exclusion Criteria:
* Pregnant or lactating females, and females of childbearing potential.
* Arthroscopy performed on index knee within 1 year of screening.
* Active depression as defined by…
What they're measuring
1
Change From Baseline in Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) Pain Domain Score at Week 2