Trials / Terminated
TerminatedNCT00396955
A Study Comparing 4 Dose Regimens of PLA-695, Naproxen, and Placebo In Subjects With Osteoarthritis Of The Knee
A Multicenter, Randomized, Double-Blind Comparison of 4 Dose Regimens of Pla-695, Naproxen, and Placebo Administered Daily for 6 Weeks in Subjects With Active Osteoarthritis of the Knee
- Status
- Terminated
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 560 (planned)
- Sponsor
- Wyeth is now a wholly owned subsidiary of Pfizer · Industry
- Sex
- All
- Age
- 50 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
Objectives: Primary:To assess the efficacy and safety of PLA-695 in subjects with active osteoarthritis (OA) of the knee. Secondary:To determine the pharmacokinetics (PK) and pharmacodynamics (PD) of PLA-695 among dose levels. To assess health outcome measures. To assess the effect of PLA-695 on biomarkers related to clinical responses. To assess PLA-695 exposure-response relationship on PD, efficacy, and safety measures. To assess pharmacogenomics (PGX) analysis in OA.
Detailed description
This is a multi-center, randomized, double-blind, double-dummy, parallel, placebo- and positive-control (naproxen), dose-ranging study to assess the efficacy and safety of 3 oral doses of PLA-695 administered QD and 1 dose of PLA-695 administered BID for 6 weeks. Subjects will be randomized to 1 of 6 treatment groups: PLA-695 50 mg, 200 mg, or 400 mg QD, PLA-695 200 mg BID, placebo, or naproxen 500 mg BID. Subjects will undergo a washout period of 2 to 14 days. The number of days for washout will be determined by the pre-study NSAID of each subject. Subjects who washout from previous therapy with an increase in signs and symptoms of OA will be randomly assigned to receive PLA-695.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | PLA-695 |
Timeline
- Start date
- 2006-11-01
- Primary completion
- 2007-11-01
- Completion
- 2007-11-01
- First posted
- 2006-11-08
- Last updated
- 2007-12-28
Locations
83 sites across 10 countries: United States, Argentina, Brazil, Canada, Hong Kong, Hungary, Mexico, Netherlands, Poland, Spain
Source: ClinicalTrials.gov record NCT00396955. Inclusion in this directory is not an endorsement.