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

March 23, 2015 updated by: Merck Sharp & Dohme LLC

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

33

Phase

  • Phase 1

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Merck Sharp & Dohme LLC

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2007

Primary Completion (Actual)

December 1, 2007

Study Completion (Actual)

December 1, 2007

Study Registration Dates

First Submitted

November 28, 2007

First Submitted That Met QC Criteria

November 28, 2007

First Posted (Estimate)

November 29, 2007

Study Record Updates

Last Update Posted (Estimate)

April 10, 2015

Last Update Submitted That Met QC Criteria

March 23, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0000-057
  • 057
  • 2007_649

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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