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

Merck Sharp & Dohme (MSD)

Status and phase: Completed; Phase 1

Conditions: Osteoarthritis, Knee

Treatments: Drug: ibuprofen; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT00565084

057

2007_649

0000-057

Details and patient eligibility

About

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.

Enrollment: 33 patients

Sex: All

Ages: 45+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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33 participants in 3 patient groups, including a placebo group

1

Active Comparator group

Description:

Ibuprofen

Treatment:

Drug: ibuprofen

2

Placebo Comparator group

Description:

Placebo 1

Treatment:

Drug: Placebo

3

Placebo Comparator group

Description:

Placebo 2

Treatment:

Drug: Placebo