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Ibuprofen-PC Compared With Ibuprofen in a GI Safety Trial

This study has been completed.
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Texas Higher Education Coordinating Board
Information provided by:
PLx Pharma
ClinicalTrials.gov Identifier:
NCT00219700
First received: September 20, 2005
Last updated: November 25, 2008
Last verified: November 2008
History of Changes
  Purpose

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
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:

U.S. FDA Resources

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)
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
No Contacts or Locations Provided
  More Information

Additional Information:
Related Info  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Ron Zimmerman/President, PLx Pharma
ClinicalTrials.gov 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:
NSAID-PC
IBU-PC

Additional relevant MeSH terms:
Osteoarthritis
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 16, 2013