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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT00565084
First received: November 28, 2007
Last updated: February 19, 2014
Last verified: February 2014
  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: ibuprofen
Drug: Placebo
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Pharmacodynamics Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Merck Sharp & Dohme Corp.:

Primary Outcome Measures:
  • 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) ] [ Designated as safety issue: No ]

    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.



Enrollment: 33
Study Start Date: March 2007
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: 1
Ibuprofen
Drug: ibuprofen
Patients will receive 800 mg ibuprofen in one of the three treatment periods.
Other Name: ibuprofen
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.

  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 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
Study First Received: November 28, 2007
Results First Received: November 18, 2008
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

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
Pharmacologic Actions
Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on April 17, 2014