A Study to Evaluate the Effect of Analgesics on a Walking Model of Knee Pain (0000-105)(COMPLETED)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis
Intervention: Naproxen (Drug); Placebo (Drug); Ultracet (Drug)
Phase: Phase 1
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp. Official(s) and/or principal investigator(s): Medical Monitor, Study Director, Affiliation: Merck Sharp & Dohme Corp.
Summary
This study will evaluate a walking model of osteoarthritis for use in testing of new
therapeutic agents. The primary hypothesis is that participants treated with Naproxen or
Ultracet will have lower Pain Intensity (PI) than those treated with Placebo during
self-paced walks on Day 3 of treatment.
Clinical Details
Official title: A Double-Blind, Placebo-Controlled, 3-Period Crossover Study to Evaluate the Analgesic Effects of Naproxen and Ultracet in a Walking Model of Osteoarthritis Knee Pain
Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Diagnostic
Primary outcome: Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to Self-paced Walks on Day 3
Secondary outcome: Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to Self-paced Walks on Day 1Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to High-paced Walks on Day 1 Change From Baseline in Time Weighted Average (TWA) Pain Intensity (PI) on a Numeric Rating Scale (NRS) Due to High-paced Walks on Day 3
Eligibility
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Has osteoarthritis of the knee and primary source of pain is knee
- Females must not be pregnant or nursing and must agree to use birth control
throughout the study
- Is willing to limit alcohol and caffeine intake
- Is willing to abstain from smoking during study visits
- Must be able to walk on a treadmill at a pace of at least 1 mile/hour
Exclusion Criteria:
- Has a medical/arthritic disease that would interfere with evaluation
- Is unable to take naproxen or Ultracet
- Has congestive heart failure or angina
- Has a history of stroke
- Has a history of uncontrolled high blood pressure
- Has a history of cancer
- Regularly uses a walker or cane
Locations and Contacts
Additional Information
Starting date: June 2008
Last updated: October 16, 2014
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