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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Analgesics
Analgesics, Non-Narcotic
Anti-Inflammatory Agents
Anti-Inflammatory Agents, Non-Steroidal
Antirheumatic Agents
Central Nervous System Agents
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Peripheral Nervous System Agents
Pharmacologic Actions
Physiological Effects of Drugs
Sensory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on October 29, 2014