CI

At a glance

ClinicalIndex Comparison Record
Phase 3Completed· 248 enrolled
Drug / intervention
Tramadol HCl/acetaminophen Extended Release +3 moredrug
Likely dose
Tramadol HCl/acetaminophen Extended Release 75 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01112267
NCT01112267Phase 3Completed
CompareCT.gov

A Randomized, Placebo-Controlled, Parallel Group, Double-Blind Clinical Study to Evaluate the Efficacy and Safety of Tramadol HCl/Acetaminophen Extended Release Tablet in Subjects With Chronic Low Back Pain

Janssen Korea, Ltd., Korea·interventional·Posted Apr 28, 2010·Updated Jul 24, 2013

In Brief

A Phase 3 clinical trial evaluating Tramadol HCl/acetaminophen Extended Release and Placebo for Low Back Pain. Completed, enrolled 248 participants.

Detailed Summary

The purpose of this study is to evaluate the efficacy and safety of extended release (ER) tramadol hydrochloride (HCl)/acetaminophen compared with placebo in participants with chronic (lasting a long time) low-back pain.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsLow Back Pain
Countries--
Collaborators--

Timeline

Phase 3CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedApr 28, 2010
Enrollment StartMay 1, 2009
Primary CompletionOct 1, 2009
TodayJul 2, 2026
Enrollment to primary: 5 monthsPosted 16.2 years ago

Interventions

Tramadol HCl/acetaminophen Extended Releasedrug

Participants will receive 1 tablet containing 75 mg of tramadol HCl and 650 mg of acetaminophen, once daily on Days 1to 3, then 1 tablet twice daily on Days 4 to 7

Placebodrug

Participants will receive 1 matching placebo tablet once daily on Days 1 to 3, then 1 tablet twice daily on Days 4 to 7

Tramadol HCl/acetaminophen Extended Releasedrug

Participants will receive 1 or 2 tablets containing 75 mg of tramadol HCl and 650 mg of acetaminophen, twice daily on Days 8 to 28

Placebodrug

Prticipants will receive 1 or 2 matching placebo tablet once daily on Days 1 to 3, then 1 tablet twice daily on Days 8 to 28