drugset / Trial / NCT00396955
A Study Comparing 4 Dose Regimens of PLA-695, Naproxen, and Placebo In Subjects With Osteoarthritis Of The Knee
RandomizedParallel-groupDouble-blindTreatment
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.
Timeline
- Start
- 2006-11
- Primary completion
- 2007-11
- Completion
- 2007-11
Outcome
Outcome not reported
Stopped: “imbalance of gastrointestinal and the lipase events”
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | GIRIPLADIB | Small molecule | 50 mg | Oral |
| Subject | GIRIPLADIB | Small molecule | 200 mg | Oral |
| Subject | GIRIPLADIB | Small molecule | 400 mg | Oral |