NCT00950651

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

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.

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 431 (actual)
• Sponsor: Labopharm Inc. · Industry
• Sex: All
• Age: 40 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Osteoarthritis, Knee
• Pain

Interventions

Type	Name	Description
DRUG	Tramadol HCl Contramid® Once A Day	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.
DRUG	Tramadol HCl Twice a day	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.

Timeline

• Start date: 2002-03-01
• Primary completion: 2002-11-01
• Completion: 2002-11-01
• First posted: 2009-08-03
• Last updated: 2012-04-30
• Results posted: 2009-08-03