Ibuprofen-PC Compared With Ibuprofen in a GI Safety Trial

This study has been completed.

First Received: September 20, 2005 Last Updated: November 25, 2008 History of Changes

Sponsor:	PLx Pharma
Collaborators:	National Institutes of Health (NIH) Texas Higher Education Coordinating Board
Information provided by:	PLx Pharma
ClinicalTrials.gov Identifier:	NCT00219700

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 II

Study Type:	Interventional
Study Design:	Treatment, Randomized, Single Blind, Active Control, Parallel Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Endoscopy Osteoarthritis

Drug Information available for: Ibuprofen Dexibuprofen

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:	PLx Pharma ( Ron Zimmerman/President )
Study ID Numbers:	PL-IB-002
Study First Received:	September 20, 2005
Last Updated:	November 25, 2008
ClinicalTrials.gov Identifier:	NCT00219700 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by PLx Pharma:

NSAID-PC
IBU-PC

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Ibuprofen
Molecular Mechanisms of Pharmacological Action
Osteoarthritis
Joint Diseases
Cyclooxygenase Inhibitors
Physiological Effects of Drugs
Enzyme Inhibitors
Rheumatic Diseases
Pharmacologic Actions

Musculoskeletal Diseases
Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Arthritis
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on November 09, 2009