Ibuprofen-PC Compared With Ibuprofen in a GI Safety Trial

This study has been completed.

Sponsors and Collaborators:	PLx Pharma 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

MedlinePlus related topics: Endoscopy Osteoarthritis

Drug Information available for: Ibuprofen Dexibuprofen

U.S. FDA Resources

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

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

Related Info This link exits the ClinicalTrials.gov site

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
Health Authority:	United States: Food and Drug Administration

Keywords provided by PLx Pharma:

NSAID-PC
IBU-PC

Study placed in the following topic categories:

Ibuprofen
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Rheumatic Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

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

ClinicalTrials.gov processed this record on January 15, 2009