Who is sponsoring NCT00348452?

NCT00348452 is sponsored by Bausch Health Americas, Inc..

What condition does NCT00348452 study?

NCT00348452 studies Chronic Pain.

What drugs are being tested in NCT00348452?

Interventions: tramadol HCl ER; celecoxib.

What is the status of NCT00348452?

NCT00348452 is currently COMPLETED.

Last reviewed 2012-06-20 · How we verify

Double-blind, Randomized, Dose-ranging, Parallel-group Comparison of the Efficacy and Safety of Extended Release Tramadol Hydrochloride (Tramadol HCl ER) 100 mg, 200 mg, 300 mg, Celecoxib 200 mg and Placebo in the Treatment of Osteoarthritis of the Knee and/or Hip.

NCT00348452 Phase 3 COMPLETED

The purpose of this study is to compare the analgesic efficacy and safety of tramadol HCl ER 100 mg, 200 mg and 300 mg once a day (QD), with placebo in patients with moderate to severe pain due to OA. For the purposes of this study, celecoxib will serve as a positive control to validate the sensitivity of the model. The study hypothesis is that tramadol HCl ER is safe and effective in the treatment of moderate to severe pain due to OA.

Details

Lead sponsor	Bausch Health Americas, Inc.
Phase	Phase 3
Status	COMPLETED
Enrolment	1000
Start date	2002-09
Completion	2003-08

Conditions

Chronic Pain

Interventions

tramadol HCl ER; celecoxib

Primary outcomes

The primary outcome is the change from baseline to week 12 in the WOMAC OA Index pain and physical function subscale scores and the patient global assessment of disease activity.