Status:
COMPLETED
Ibuprofen-PC Compared With Ibuprofen in a GI Safety Trial
Lead Sponsor:
PLx Pharma
Collaborating Sponsors:
National Institutes of Health (NIH)
Texas Higher Education Coordinating Board
Conditions:
Osteoarthritis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
To determine the safety and efficacy of 3 x 800 mg/day IBU-PC assessed by endoscopy and incidence of adverse events
Eligibility Criteria
Inclusion
- moderate osteoarthritis in the hip and/or knee requiring chronic pain medication
- others per protocol
Exclusion
- sensitivity to NSAIDs and lecithin
- hypertension
- history of GI and other specific problems
- use of medications and other criteria per the protocol
Key Trial Info
Start Date :
January 1 2005
Trial Type :
INTERVENTIONAL
End Date :
November 1 2005
Estimated Enrollment :
125 Patients enrolled
Trial Details
Trial ID
NCT00219700
Start Date
January 1 2005
End Date
November 1 2005
Last Update
November 26 2008
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