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

Primary Purpose

Osteoarthritis, Knee

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

ibuprofen

Placebo

About this trial

This is an interventional treatment trial for Osteoarthritis, Knee

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Arm Description

Ibuprofen

Placebo 1

Placebo 2

Outcomes

Primary Outcome Measures

Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT00565084

First Posted

November 28, 2007

Last Updated

March 23, 2015

Sponsor

Merck Sharp & Dohme LLC

1. Study Identification

Unique Protocol Identification Number

NCT00565084

Brief Title

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

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 Type

Interventional

2. Study Status

Record Verification Date

March 2015

Overall Recruitment Status

Completed

Study Start Date

March 2007 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Merck Sharp & Dohme LLC

4. Oversight

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Osteoarthritis, Knee

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

33 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Active Comparator

Arm Description

Ibuprofen

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo 1

Arm Title

Arm Type

Placebo Comparator

Arm Description

Placebo 2

Intervention Type

Drug

Intervention Name(s)

ibuprofen

Intervention Description

Patients will receive 800 mg ibuprofen in one of the three treatment periods.

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Patients will receive placebo to ibuprofen in two of the three treatment periods.

Primary Outcome Measure Information:

Title

Change in Average Pain Intensities Measured From the Pre-Treatment Walk (Baseline) at 3 Post-Treatment Walks

Description

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)

10. Eligibility

Sex

All

Minimum Age & Unit of Time

45 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Medical Monitor

Organizational Affiliation

Merck Sharp & Dohme LLC

Official's Role

Study Director

12. IPD Sharing Statement

Citations:

PubMed Identifier

20175977

Citation

Peeva E, Beals CR, Bolognese JA, Kivitz AJ, Taber L, Harman A, Smugar SS, Moskowitz RW. A walking model to assess the onset of analgesia in osteoarthritis knee pain. Osteoarthritis Cartilage. 2010 May;18(5):646-53. doi: 10.1016/j.joca.2009.12.008. Epub 2010 Feb 6.

Results Reference

result

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

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