A Study to Evaluate the Effect of Analgesics on a Walking Model of Knee Pain
Information source: Merck
Information obtained from ClinicalTrials.gov on November 03, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Osteoarthritis
Intervention: non-product or non-Merck product (Drug); Comparator: Placebo (Drug); Comparator: Ultracet (tramadol/acetaminophen) (Drug)
Phase: Phase 1
Status: Recruiting
Sponsored by: Merck Official(s) and/or principal investigator(s):
Medical Monitor, Study Director, Affiliation: Merck
Overall contact:
Toll Free Number, Phone: 1-888-577-8839
Summary
This study will evaluate a walking model of osteoarthritis for use in testing of new
therapeutic agents.
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: Diagnostic, Randomized, Double Blind (Subject, Investigator), Placebo Control, Crossover Assignment, Efficacy Study
Primary outcome: Comparison of the effects of naproxen and Ultracet to placebo using on average pain intensity during self-paced walks
Secondary outcome: Comparison of the effects of naproxen and Ultracet to placebo on average pain intensity during high pace walks, for each individual walk, at each time point, and the time to moderate or severe pain
Eligibility
Minimum age: 45 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Patient has osteoarthritis of the knee and primary source of pain is knee
- Female patients must not be pregnant or nursing and must agree to use birth control
throughout the study
- Patient is willing to limit alcohol and caffeine intake
- Patient is willing to abstain from smoking during study visits
- Patient must be able to walk on a treadmill at a pace of at least 1 mile/hour
Exclusion Criteria:
- Patient has a medical/arthritic disease that would interfere with evaluation
- Patient is unable to take naproxen or Ultracet
- Patient has congestive heart failure or angina
- Patient has a history of stroke
- Patient has a history of uncontrolled high blood pressure
- Patient has a history of cancer
- Patient regularly uses a walker or cane
Locations and Contacts
Toll Free Number, Phone: 1-888-577-8839
Call for Information, Peoria, Arizona 85381-0000, United States; Recruiting
Additional Information
Starting date: June 2008
Ending date: December 2008
Last updated: October 13, 2008
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