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

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ClinicalTrials.gov Identifier: NCT00565084
Recruitment Status : Completed
First Posted : November 29, 2007
Results First Posted : July 7, 2009
Last Update Posted : April 10, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Osteoarthritis, Knee Drug: ibuprofen Drug: Placebo Phase 1

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 33 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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
Study Start Date : March 2007
Primary Completion Date : December 2007
Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Osteoarthritis
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
Active Comparator: 1
Ibuprofen
Drug: ibuprofen
Patients will receive 800 mg ibuprofen in one of the three treatment periods.
Placebo Comparator: 2
Placebo 1
Drug: Placebo
Patients will receive placebo to ibuprofen in two of the three treatment periods.
Placebo Comparator: 3
Placebo 2
Drug: Placebo
Patients will receive placebo to ibuprofen in two of the three treatment periods.


Outcome Measures

Primary Outcome Measures :
  1. Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks [ Time Frame: 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) ]

    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.



Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00565084


Sponsors and Collaborators
Merck Sharp & Dohme Corp.
Investigators
Study Director: Medical Monitor Merck Sharp & Dohme Corp.
More Information

Publications:
Responsible Party: Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier: NCT00565084     History of Changes
Other Study ID Numbers: 0000-057
057
2007_649
First Posted: November 29, 2007    Key Record Dates
Results First Posted: July 7, 2009
Last Update Posted: April 10, 2015
Last Verified: March 2015

Additional relevant MeSH terms:
Osteoarthritis
Osteoarthritis, Knee
Arthritis
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Ibuprofen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Inflammatory Agents
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action