drugset / Trial / NCT00325858

A Study Comparing the Effectiveness and Safety of Varying Dose Strengths (100, 200, 300 and 400 mg) of Extended-release Tramadol HCl With Placebo for the Treatment of Osteoarthritis(OA) of the Knee and/or Hip

NCT00325858

Phase 3 Completed 1000 enrolled Bausch Health Americas, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to compare the effectiveness of multiple doses of once daily tramadol HCl ER (100, 200, 300 and 400 mg) to placebo in patients with moderate to severe pain due to OA. The study hypothesis is that tramadol HCl ER is safe and effective in the treatment of patients with moderate to severe pain due to OA.

Timeline

Start
2002-01
Primary completion
Completion
2003-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Tramadol Other / unclassified 100 mg
Subject Tramadol Other / unclassified 200 mg
Subject Tramadol Other / unclassified 300 mg
Subject Tramadol Other / unclassified 400 mg

Indications