Ibuprofen-PC Compared With Ibuprofen in a GI Safety Trial
Information source: PLx Pharma
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis
Intervention: Ibuprofen-PC (Drug)
Phase: Phase 2
Status: Active, not recruiting
Sponsored by: PLx Pharma
Summary
To determine the safety and efficacy of 3 x 800 mg/day IBU-PC assessed by endoscopy and
incidence of adverse events
Clinical Details
Official title: Phase II, Randomized, Blinded Study of Ibuprofen-PC and Ibuprofen in Patients With Osteoarthritis to Investigate Efficacy and Gastrointestinal Toxicity
Study design: Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: Lanza score assessed by endoscopy at baseline and after six weeks of treatment to measure GI safety.
Secondary outcome: WOMAC and VAS scores every two weeks until end of treatment to measure efficacy.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: January 2005
Ending date: November 2005
Last updated: December 21, 2005
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