Ibuprofen-PC Compared With Ibuprofen in a GI Safety Trial

• Status: Completed
• Trial end date: 2005-11-01
• Target enrollment: 0
• Participant gender: All

Summary

To determine the safety and efficacy of 3 x 800 mg/day IBU-PC assessed by endoscopy and incidence of adverse events

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: PLx Pharma
• Collaborators: National Institutes of Health (NIH); Texas Higher Education Coordinating Board
• Treatments: Ibuprofen

Criteria

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