At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 431 enrolled

Drug / intervention

Tramadol HCl Contramid® Once A Day +1 moredrug

Likely dose

Tramadol HCl Contramid® Once A Day 400 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/NCT00950651

NCT00950651Phase 3Completed

Compare CT.gov

A Comparison of the Analgesic Efficacy and Safety of Once Daily Tramadol HCl / Contramid® Tablets to Twice Daily Tramadol HCl (SR) for the Treatment of Osteoarthritis of the Knee.

Labopharm Inc.·interventional·Posted Aug 3, 2009·Updated Apr 30, 2012

In Brief

A Phase 3 clinical trial evaluating Tramadol HCl Contramid® Once A Day and Tramadol HCl Twice a day for Osteoarthritis, Knee and Pain. Completed, enrolled 431 participants.

Detailed Summary

A randomised, multi-centre, double-blind, double dummy, two arm parallel design study to compare the efficacy, safety, and clinical benefit of the test and reference product after treatment for 84 days in patients with osteoarthritis of the knee.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsOsteoarthritis, Knee, Pain

Countries--

Collaborators--

Timeline

Phase 3CompletedFinished

20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartMar 2002

Primary CompletionNov 2002

First PostedAug 2009

TodayJul 2026

First PostedAug 3, 2009

Enrollment StartMar 1, 2002

Primary CompletionNov 1, 2002

TodayJul 2, 2026

Enrollment to primary: 8 monthsPosted 16.9 years ago

Interventions

Tramadol HCl Contramid® Once A Daydrug

The patients orally self-administered the study medication: either 100, 200, 300 or 400 mg Tramadol HCl Contramid® Once A Day. Each patient was titrated to his or her optimum dose (up to a maximum of 400 mg) during the Titration Phase, which lasted between 4 and 12 days. The optimum dose was taken throughout the study.

Tramadol HCl Twice a daydrug

The patients orally self-administered the study medication: either 200, 300 or 400 mg Tramadol HCl Twice a day. Each patient was titrated to his or her optimum dose (up to a maximum of 400 mg) during the Titration Phase, which lasted between 4 and 12 days. The optimum dose was taken throughout the study.