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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
Osteoarthritis Drug: Ibuprofen-PC Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single
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)
Sexes Eligible for Study:   All
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
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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

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 September 21, 2017