Overview

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