Tolerability and Efficacy of Ibuprofen 800 mg in a Walking Model of Osteoarthritis Pain (0000-057)

Phase 1

Completed

• Conditions: Osteoarthritis, Knee
• Interventions: Drug: Placebo; Drug: ibuprofen

• Registration Number: NCT00565084
• Lead Sponsor: Merck Sharp & Dohme LLC

Brief Summary

The purpose of the study is to see if generic ibuprofen has an effect on osteoarthritis knee pain during a series of timed walks on a treadmill.

Detailed Description

Not available

Study Timeline

• Study Start: 2007-03
• Study First Submitted: 2007-11-28
• Study First Submitted QC: 2007-11-28
• Study First Posted: 2007-11-29
• Primary Completion: 2007-12
• Study Completion: 2007-12
• Results First Submitted: 2008-11-18
• Results First Submitted QC: 2009-05-21
• Results First Posted: 2009-07-07
• Status Verified: 2015-03
• Last Update Submitted: 2015-03-23
• Last Update Posted: 2015-04-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 33

Inclusion Criteria

• The primary source of pain is the study knee of one lower extremity
• Patient is willing to limit alcohol and caffeine intake
• Aside from osteoarthritis, patient is in generally good health
• Patient is capable of completing protocol specified walks
• Patient is able to understand and complete questionnaires in English
• Patient has previously benefited from the use of either NSAIDs, COX-2 inhibitors, or acetaminophen

Exclusion Criteria

• Patient has another condition which could interfere with evaluating pain in the knee being tested
• Patient is not able to take a non-steroidal anti-inflammatory drug (NSAID) such as ibuprofen
• Patient has a history or current evidence of stroke, transient ischemic attack, liver disease or cancer
• Patient has a history or current evidence of dizziness, unsteadiness, or falling
• Patient has congestive heart failure, unstable angina or uncontrolled high blood pressure
• Patient has a history of stomach, digestive track, or small intestine surgery
• Patient is unable to complete the study questionnaires in English

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
2	Placebo	Placebo 1
1	ibuprofen	Ibuprofen
3	Placebo	Placebo 2

Primary Outcome Measures

Name	Time	Method
Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks	All pain intensities measured from the pre-treatment walk and 3 post-treatment walks (within 3 and half hours post dose, 15 minutes each walk separated by a 45-minute rest interval)	Pain intensities(PIs) were measured at pre-dose and 3 post-dose walks (15 Minutes Each Separated by a 45-Minute Rest Interval) on an 11 point scale(0=no pain; 10=worst pain) and averaged for each walk.; Change from baseline was average of post-dose PIs minus average of pre-dose PI.