drugset / Trial / NCT00347724

A Study Comparing the Effectiveness and Safety of Extended-release Tramadol Versus Placebo in the Treatment of Chronic Low Back Pain

NCT00347724

Phase 3 Completed 600 enrolled Bausch Health Americas, Inc.
RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to compare the analgesic efficacy of oral, once-daily tramadol ER 300 mg and 200 mg to placebo in patients with moderate to severe chronic low back pain requiring daily analgesic treatment. The study hypothesis is that tramadol ER is effective in the treatment of moderate to severe chronic low back pain.

Timeline

Start
2000-11
Primary completion
Completion
2001-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Tramadol Other / unclassified 200 mg Oral
Subject Tramadol Other / unclassified 300 mg Oral

Indications