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

NCT00565084 | Completed Phase 1 Results

• 3 other identifiers: 0000-0570572007_649
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Osteoarthritis, Knee

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (3)

1

ACTIVE COMPARATOR

Ibuprofen

Drug: ibuprofen

2

PLACEBO COMPARATOR

Placebo 1

Drug: Placebo

3

PLACEBO COMPARATOR

Placebo 2

Drug: Placebo

Interventions

ibuprofen DRUG

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

1

Placebo DRUG

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

2; 3

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

Related 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 2010 Feb 6.

  PMID: 20175977 RESULT

MeSH Terms

Conditions

Osteoarthritis, Knee

Interventions

Ibuprofen

Condition Hierarchy (Ancestors)

Osteoarthritis; Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Intervention Hierarchy (Ancestors)

Phenylpropionates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

1-800-672-6372

Study Officials

• Medical Monitor

  Merck Sharp & Dohme LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 28, 2007
• First Posted: November 29, 2007
• Study Start: March 1, 2007
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: April 10, 2015
• Results First Posted: July 7, 2009

Record last verified: 2015-03