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Ibuprofen-PC Compared With Ibuprofen in a GI Safety Trial

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00219700
First Posted: September 22, 2005
Last Update Posted: November 26, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborators:
National Institutes of Health (NIH)
Texas Higher Education Coordinating Board
Information provided by:
PLx Pharma
  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
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)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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:
Responsible Party: Ron Zimmerman/President, PLx Pharma
ClinicalTrials.gov Identifier: NCT00219700     History of Changes
Other Study ID Numbers: PL-IB-002
First Submitted: September 20, 2005
First Posted: September 22, 2005
Last Update Posted: November 26, 2008
Last Verified: November 2008

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
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action