Who is sponsoring NCT00950651?

NCT00950651 is sponsored by Labopharm Inc..

What condition does NCT00950651 study?

NCT00950651 studies Osteoarthritis, Knee, Pain.

What drugs are being tested in NCT00950651?

Interventions: Tramadol HCl Contramid® Once A Day, Tramadol HCl Twice a day.

What is the status of NCT00950651?

NCT00950651 is currently COMPLETED.

Last reviewed 2012-04-25 · How we verify

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.

NCT00950651 Phase 3 COMPLETED Results posted

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.

Details

Lead sponsor	Labopharm Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	431
Start date	2002-03
Completion	2002-11

Conditions

Osteoarthritis, Knee
Pain

Interventions

Tramadol HCl Contramid® Once A Day
Tramadol HCl Twice a day

Primary outcomes

Percentage of Change From Baseline in WOMAC Pain Subscale Score at Week 12 — Baseline to week 12
The WOMAC is a statistically validated, 24-item questionnaire assessing current OA symptoms and functional limitations. The Pain subscale score consists of 5 items each rated on a 100mm VAS scale (0mm=no pain to 100mm=extreme pain). In case of premature discontinuation, the last assessment was used to calculate the percentage of change.