drugset / Trial / NCT00689273

Randomized, Double-Blind, Placebo-Controlled, Phase 2 Study In Subjects With Osteoarthritic Pain Of The Knee

NCT00689273 ↗

Phase 2 Completed 159 enrolled Pfizer
RandomizedParallel-groupTriple-blindTreatment

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.

Timeline

Start
2008-08-05
Primary completion
2008-11-27
Completion
2008-11-27

Outcome

Missed primary endpoint

registry analysis (superiority test); PF-04136309 vs Placebo; p = 0.39; Least Square (LS) Mean Difference -0.49 (80% CI -1.23 to 0.24); Mixed Models Analysis NCT00689273 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject PF-4136309 Small molecule 500 mg —

Indications