Status:
COMPLETED
An Effectiveness and Safety Study of Acetaminophen Extended Release Caplets in Treating Muscle Aches and Soreness That Occur After a Marathon Race
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Collaborating Sponsors:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Conditions:
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
The purpose of this study is to compare the effectiveness of acetaminophen extended release caplets to placebo in treating the muscle aching and pain (soreness) that occurs after a marathon.
Detailed Description
This is a randomized, double-blind, placebo-controlled study to compare the effectiveness and safety of acetaminophen and placebo in treating muscle aching and pain (soreness) that occurs in subjects ...
Eligibility Criteria
Inclusion
- Patients must be able to comply with the study schedule
- be able to swallow the study medication
- complete the marathon
- not take any analgesics after completing the marathon and before their eligibility to participate in the study has been determined
- rate their muscle soreness at least a 4, on a 0 - 10 point scale
Exclusion
- Previous diagnosis of osteoarthritis
- currently have or have had a medical condition that may be relevant in one's eligibility to participate in the study
- known hypersensitivity to acetaminophen
- unable to understand or follow the instructions for the study
- taken any investigational medication within 30 days of the marathon
Key Trial Info
Start Date :
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2004
Estimated Enrollment :
665 Patients enrolled
Trial Details
Trial ID
NCT00240851
End Date
February 1 2004
Last Update
June 19 2015
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