drugset / Trial / NCT00347685

A One-year, Open-label Study to Assess the Safety and Effectiveness of Extended Release Tramadol HCl in the Treatment of Chronic, Non-malignant Pain.

NCT00347685

Phase 3 Completed 650 enrolled Bausch Health Americas, Inc.
Non-randomizedSingle-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the safety of tramadol HCl ER following long-term treatment. The study hypothesis is that long-term treatment with tramadol HCl ER is safe and effective for the treatment of chronic, non-malignant pain.

Timeline

Start
2000-10
Primary completion
Completion
2003-02

Drugs

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

Indications