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Completed

NCT Number: NCT00219700

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

Completed

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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

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

Secondary outcomes

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

Interested in participating?

Completed

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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.

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