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

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.

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Key information

Conditions

Osteoarthritis, Knee Arthritis Joint Diseases Musculoskeletal Diseases Osteoarthritis Rheumatic Diseases

Age range

45 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Who can participate

Healthy volunteers accepted: No

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

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

Treatment and study plan

Ibuprofen

Drug

Patients will receive 800 mg ibuprofen in one of the three treatment periods.

Placebo

Drug

Patients will receive placebo to ibuprofen in two of the three treatment periods.

Primary outcomes

Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks

Time frame: 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.

Sponsors and collaborators

Lead sponsor

Merck Sharp & Dohme LLC

Industry

Registry information

Official study title

A Randomized, Placebo-Controlled Single-Dose 3-Period Crossover Study to Assess the Tolerability and Efficacy of Ibuprofen 800 mg in a Walking Model of Osteoarthritis Pain

Important dates

Study start: 2007
Primary completion: 2007
Study completion: 2007
First posted: Nov 29, 2007
Registry last updated: Apr 10, 2015

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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Completed