ClinicalTrials.gov
ClinicalTrials.gov Menu

Ibuprofen-PC Compared With Ibuprofen in a GI Safety Trial

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.
ClinicalTrials.gov Identifier: NCT00219700
Recruitment Status : Completed
First Posted : September 22, 2005
Last Update Posted : November 26, 2008
Sponsor:
Collaborators:
National Institutes of Health (NIH)
Texas Higher Education Coordinating Board
Information provided by:
PLx Pharma

Brief Summary:
To determine the safety and efficacy of 3 x 800 mg/day IBU-PC assessed by endoscopy and incidence of adverse events

Condition or disease Intervention/treatment Phase
Osteoarthritis Drug: Ibuprofen-PC Phase 2

Study Type : Interventional  (Clinical Trial)
Enrollment : 125 participants
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
Study Start Date : January 2005
Actual Primary Completion Date : November 2005
Actual Study Completion Date : November 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources




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

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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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

Additional Information:
Responsible Party: Ron Zimmerman/President, PLx Pharma
ClinicalTrials.gov Identifier: NCT00219700     History of Changes
Other Study ID Numbers: PL-IB-002
First Posted: September 22, 2005    Key Record Dates
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