Trial | NCT00219700  Report issue

Title

Ibuprofen-PC Compared With Ibuprofen in a GI Safety Trial
Phase II, Randomized, Blinded Study of Ibuprofen-PC and Ibuprofen in Patients With Osteoarthritis to Investigate Efficacy and Gastrointestinal Toxicity

  • Phase

    Phase 2

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    ibuprofen ...

  • Study Participants

    125
To determine the safety and efficacy of 3 x 800 mg/day IBU-PC assessed by endoscopy and incidence of adverse events
Study Started
Jan 31
2005
Primary Completion
Nov 30
2005
Study Completion
Nov 30
2005
Last Update
Nov 26
2008
Estimate

Drug Ibuprofen-PC

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
No Results Posted