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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

33 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-03-31

Study Completion Date

2007-12-31

Brief Summary

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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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Detailed Description

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Conditions

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Osteoarthritis, Knee

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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1

Ibuprofen

Group Type ACTIVE_COMPARATOR

ibuprofen

Intervention Type DRUG

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

2

Placebo 1

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

3

Placebo 2

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

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

Interventions

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ibuprofen

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

Intervention Type DRUG

Placebo

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

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No