Ibuprofen-PC Compared With Ibuprofen in a GI Safety Trial - Tabular View

Tracking Information
First Received Date ^ICMJE	September 20, 2005
Last Updated Date	November 25, 2008
Start Date ^ICMJE	January 2005
Primary Completion Date	November 2005 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: September 20, 2005)	Lanza score assessed by endoscopy at baseline and after six weeks of treatment to measure GI safety.
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT00219700 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: September 20, 2005)	WOMAC and VAS scores every two weeks until end of treatment to measure efficacy.
Original Secondary Outcome Measures ^ICMJE	Same as current

Descriptive Information
Brief Title ^ICMJE	Ibuprofen-PC Compared With Ibuprofen in a GI Safety Trial
Official Title ^ICMJE	Phase II, Randomized, Blinded Study of Ibuprofen-PC and Ibuprofen in Patients With Osteoarthritis to Investigate Efficacy and Gastrointestinal Toxicity
Brief Summary	To determine the safety and efficacy of 3 x 800 mg/day IBU-PC assessed by endoscopy and incidence of adverse events
Detailed Description
Study Phase	Phase II
Study Type ^ICMJE	Interventional
Study Design ^ICMJE	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Condition ^ICMJE	Osteoarthritis
Intervention ^ICMJE	Drug: Ibuprofen-PC
Study Arms / Comparison Groups
Publications *
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Completed
Enrollment ^ICMJE	125
Completion Date	November 2005
Primary Completion Date	November 2005 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	Inclusion Criteria: moderate osteoarthritis in the hip and/or knee requiring chronic pain medication others per protocol Exclusion Criteria: sensitivity to NSAIDs and lecithin hypertension history of GI and other specific problems use of medications and other criteria per the protocol
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE

Administrative Information
NCT ID ^ICMJE	NCT00219700
Responsible Party	Ron Zimmerman/President, PLx Pharma
Study ID Numbers ^ICMJE	PL-IB-002
Study Sponsor ^ICMJE	PLx Pharma
Collaborators ^ICMJE	National Institutes of Health (NIH) Texas Higher Education Coordinating Board
Investigators ^ICMJE
Information Provided By	PLx Pharma
Verification Date	November 2008
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP