Phase 1
Completed N=33
Tolerability and Efficacy of Ibuprofen 800 mg in a Walking Model of Osteoarthritis Pain (0000-057)
Osteoarthritis, Knee
Source: ClinicalTrials.gov NCT00565084 ↗
Enrolled (actual)
33
Serious AEs
3.0%
Results posted
Jul 2009
Primary outcomePrimary: 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
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.
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 |
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
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. Informational only — not medical advice.