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

Study Overview
=================
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.

Official 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

Conditions
-----------------
Osteoarthritis, Knee

Intervention / Treatment
-----------------
* Drug: ibuprofen
* Drug: Placebo


Participation Criteria
=================
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

Ages Eligible for Study
-----------------
Minimum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: 1<br>Ibuprofen | Drug: ibuprofen<br>* Patients will receive 800 mg ibuprofen in one of the three treatment periods.<br>|
| Placebo Comparator: 2<br>Placebo 1 | Drug: Placebo<br>* Patients will receive placebo to ibuprofen in two of the three treatment periods.<br>|
| Placebo Comparator: 3<br>Placebo 2 | Drug: Placebo<br>* Patients will receive placebo to ibuprofen in two of the three treatment periods.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks | 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. | 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) |