Ibuprofen-PC Compared With Ibuprofen in a GI Safety Trial

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

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Key information

Conditions

Osteoarthritis Arthritis Joint Diseases Musculoskeletal Diseases Rheumatic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ibuprofen-PC

Drug

Primary outcomes

Lanza score assessed by endoscopy at baseline and after six weeks of treatment to measure GI safety.

Secondary outcomes

WOMAC and VAS scores every two weeks until end of treatment to measure efficacy.

Sponsors and collaborators

Lead sponsor

PLx Pharma

Industry

Collaborators

National Institutes of Health (NIH)
Texas Higher Education Coordinating Board

Registry information

Official study title

Phase II, Randomized, Blinded Study of Ibuprofen-PC and Ibuprofen in Patients With Osteoarthritis to Investigate Efficacy and Gastrointestinal Toxicity

Important dates

Study start: 2005
Primary completion: 2005
Study completion: 2005
First posted: Sep 22, 2005
Registry last updated: Nov 26, 2008

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed