Ibuprofen-PC Compared With Ibuprofen in a GI Safety Trial
November 25, 2008 updated by: PLx Pharma
Phase II, Randomized, Blinded Study of Ibuprofen-PC and Ibuprofen in Patients With Osteoarthritis to Investigate Efficacy and Gastrointestinal Toxicity
To determine the safety and efficacy of 3 x 800 mg/day IBU-PC assessed by endoscopy and incidence of adverse events
Study Overview
Study Type
Interventional
Enrollment
125
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Lanza score assessed by endoscopy at baseline and after six weeks of treatment to measure GI safety.
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Secondary Outcome Measures
Outcome Measure |
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WOMAC and VAS scores every two weeks until end of treatment to measure efficacy.
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Helpful Links
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
January 1, 2005
Primary Completion (Actual)
November 1, 2005
Study Completion (Actual)
November 1, 2005
Study Registration Dates
First Submitted
September 20, 2005
First Submitted That Met QC Criteria
September 20, 2005
First Posted (Estimate)
September 22, 2005
Study Record Updates
Last Update Posted (Estimate)
November 26, 2008
Last Update Submitted That Met QC Criteria
November 25, 2008
Last Verified
November 1, 2008
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Joint Diseases
- Musculoskeletal Diseases
- Rheumatic Diseases
- Arthritis
- Osteoarthritis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Peripheral Nervous System Agents
- Enzyme Inhibitors
- Analgesics
- Sensory System Agents
- Anti-Inflammatory Agents, Non-Steroidal
- Analgesics, Non-Narcotic
- Anti-Inflammatory Agents
- Antirheumatic Agents
- Cyclooxygenase Inhibitors
- Ibuprofen
Other Study ID Numbers
- PL-IB-002
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.