Walking Model for Osteoarthritis - Full Text View

Sponsored by:	Merck
Information provided by:	Merck
ClinicalTrials.gov Identifier:	NCT00565084

Purpose

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.

Condition	Intervention	Phase
Osteoarthritis, Knee	Drug: Comparator: ibuprofen	Phase 0

MedlinePlus related topics: Osteoarthritis

Drug Information available for: Ibuprofen Dexibuprofen

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Pharmacodynamics Study
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

Further study details as provided by Merck:

Primary Outcome Measures:

Patient reported pain intensity at the following timepoints: 2, 4, 6, 8, 10, 12, and 15 minutes [ Time Frame: Over 15 Minutes ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Time to moderate pain during all post-dose walks; Patient Global Response to Therapy and WOMAC VA 3.0 following the last post-dose walk [ Time Frame: Variable ] [ Designated as safety issue: No ]

Study Start Date:	March 2007
Study Completion Date:	December 2007
Primary Completion Date:	November 2007 (Final data collection date for primary outcome measure)

Intervention Details:

Duration of Treatment: 3 doses at 3 separate visits

Eligibility

Ages Eligible for Study:	45 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00565084

Sponsors and Collaborators

Merck

Investigators

Study Director:

Medical Monitor

Merck

More Information

Responsible Party:	Merck & Co., Inc. ( Dr. Barry Gertz, Executive Vice President, Clinical and Quantitative Sciences )
Study ID Numbers:	2007_649
Study First Received:	November 28, 2007
Last Updated:	September 26, 2008
ClinicalTrials.gov Identifier:	NCT00565084
Health Authority:	United States: Institutional Review Board

Study placed in the following topic categories:

Osteoarthritis, Knee
Ibuprofen
Musculoskeletal Diseases
Osteoarthritis

Joint Diseases
Arthritis
Pain
Rheumatic Diseases

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Pharmacologic Actions
Analgesics, Non-Narcotic

Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on January 15, 2009