Ibuprofen-PC Compared With Ibuprofen in a GI Safety Trial
This study has been completed.
First Posted: September 22, 2005
Last Update Posted: November 26, 2008
National Institutes of Health (NIH)
Texas Higher Education Coordinating Board
Information provided by:
To determine the safety and efficacy of 3 x 800 mg/day IBU-PC assessed by endoscopy and incidence of adverse events
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||Phase II, Randomized, Blinded Study of Ibuprofen-PC and Ibuprofen in Patients With Osteoarthritis to Investigate Efficacy and Gastrointestinal Toxicity|
Resource links provided by NLM:
U.S. FDA Resources
Further study details as provided by PLx Pharma:
Primary Outcome Measures:
- Lanza score assessed by endoscopy at baseline and after six weeks of treatment to measure GI safety.
Secondary Outcome Measures:
- WOMAC and VAS scores every two weeks until end of treatment to measure efficacy.
|Study Start Date:||January 2005|
|Study Completion Date:||November 2005|
|Primary Completion Date:||November 2005 (Final data collection date for primary outcome measure)|
Contacts and Locations
No Contacts or Locations Provided