Ibuprofen-PC Compared With Ibuprofen in a GI Safety Trial

Phase 2

Completed

• Conditions: Osteoarthritis

• Registration Number: NCT00219700
• Lead Sponsor: PLx Pharma

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

Not available

Study Timeline

• Study Start: 2005-01
• Study First Submitted: 2005-09-20
• Study First Submitted QC: 2005-09-20
• Study First Posted: 2005-09-22
• Primary Completion: 2005-11
• Study Completion: 2005-11
• Status Verified: 2008-11
• Last Update Submitted: 2008-11-25
• Last Update Posted: 2008-11-26

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 125

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Lanza score assessed by endoscopy at baseline and after six weeks of treatment to measure GI safety.

Secondary Outcome Measures

Name	Time	Method
WOMAC and VAS scores every two weeks until end of treatment to measure efficacy.