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Ibuprofen-PC Compared With Ibuprofen in a GI Safety Trial

This study has been completed.
National Institutes of Health (NIH)
Texas Higher Education Coordinating Board
Information provided by:
PLx Pharma Identifier:
First received: September 20, 2005
Last updated: November 25, 2008
Last verified: November 2008
To determine the safety and efficacy of 3 x 800 mg/day IBU-PC assessed by endoscopy and incidence of adverse events

Condition Intervention Phase
Drug: Ibuprofen-PC
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind
Primary Purpose: Treatment
Official Title: Phase II, Randomized, Blinded Study of Ibuprofen-PC and Ibuprofen in Patients With Osteoarthritis to Investigate Efficacy and Gastrointestinal Toxicity

Resource links provided by NLM:

Further study details as provided by PLx Pharma:

Primary Outcome Measures:
  • Lanza score assessed by endoscopy at baseline and after six weeks of treatment to measure GI safety.

Secondary Outcome Measures:
  • WOMAC and VAS scores every two weeks until end of treatment to measure efficacy.

Estimated Enrollment: 125
Study Start Date: January 2005
Study Completion Date: November 2005
Primary Completion Date: November 2005 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

Additional Information:
Responsible Party: Ron Zimmerman/President, PLx Pharma Identifier: NCT00219700     History of Changes
Other Study ID Numbers: PL-IB-002 
Study First Received: September 20, 2005
Last Updated: November 25, 2008
Health Authority: United States: Food and Drug Administration

Keywords provided by PLx Pharma:

Additional relevant MeSH terms:
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on October 27, 2016