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

Osteoarthritis, Knee Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00565084
• Other study ID #: 0000-057
• Secondary ID: 0572007_649
• Status: Completed
• Phase: Phase 1
• First received: November 28, 2007
• Last updated: March 23, 2015
• Start date: March 2007
• Est. completion date: December 2007

Study information

• Verified date: March 2015
• Source: Merck Sharp & Dohme Corp.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 33
• Est. completion date: December 2007
• Est. primary completion date: December 2007
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Osteoarthritis
• Osteoarthritis, Knee

Intervention

Drug:
• ibuprofen
Patients will receive 800 mg ibuprofen in one of the three treatment periods.
• Placebo
Patients will receive placebo to ibuprofen in two of the three treatment periods.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Merck Sharp & Dohme Corp.

References & Publications (1)

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 20 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	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)	No