Phase 1 N=33 Randomized Double-blind Treatment

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

Osteoarthritis, Knee

Bottom Line

View on ClinicalTrials.gov: NCT00565084 ↗

Enrolled (actual)

Serious AEs

3.0%

Results posted

Jul 2009

Primary outcome: Primary: Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks — 0.24; 0.18; 0.18 Units on a Scale — p=0.743

Study Design & Population

Study type: Interventional
Phase: Phase 1
Interventions: ibuprofen (Drug); Placebo (Drug)
Age: Adult, Older Adult · 45+ yrs
Sex: All
Sponsor: Merck Sharp & Dohme LLC
Primary completion: Dec 2007

Outcome Measures

Outcome	Result	p-value
PRIMARY Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks	0.24; 0.18; 0.18	0.743

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.

Eligibility Criteria

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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00565084). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.