An Effectiveness and Safety Study Comparing Acetaminophen (3900 mg/Day) to Ibuprofen (1200 mg/Day) in the Treatment of Post-Race Muscle Soreness.
June 28, 2011 updated by: Johnson & Johnson Consumer and Personal Products Worldwide
A Randomized, Double-Blind Study Evaluating Acetaminophen Extended Release Caplets (3900 mg/Day) and Ibuprofen (1200 mg/Day) in the Treatment of Post-Race Muscle Soreness.
The purpose of this study is to compare the effectiveness and safety of acetaminophen extended release caplets and ibuprofen in relieving the muscle soreness that occurs after a marathon.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
The objective of this randomized, double-blind study is to compare the effectiveness and safety of acetaminophen extended release caplets and ibuprofen in relieving the muscle soreness that occurs in subjects who complete a marathon.
Subjects are randomized to receive acetaminophen extended release caplets, 3900 mg/day (two 650 mg caplets taken three times a day, for five days) or ibuprofen caplets, 1200 mg/day (two 200 mg caplets taken three times a day, for five days).
The primary measurement of efficacy is the average change in muscle soreness from baseline for both the morning and evening assessments.
Safety assessments consist of monitoring adverse events, and a physical examination including vital signs, weight, a review of concomitant medications, and a urine pregnancy test for female subjects.
Two hypotheses are examined in a step-down approach.
The first hypothesis is that acetaminophen extended release is not inferior to ibuprofen in relieving the muscle soreness that occurs after a marathon.
If acetaminophen extended release is not inferior to ibuprofen in relieving the muscle soreness that occurs after a marathon, the second hypothesis is that acetaminophen extended release (3900 mg/day) is superior to ibuprofen (1200 mg/day) in relieving the muscle soreness that occurs after a marathon.
Two acetaminophen 650 mg extended release caplets, taken by mouth, three times a day for five days or two ibuprofen 200 mg caplets, taken by mouth, three times a day for five days.
Study Type
Interventional
Enrollment (Actual)
483
Phase
- Phase 4
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Patients must complete the marathon
- be able to swallow the study medication
- comply with study requirements regarding the use of any other pain medications before, during or after the marathon
- rate their muscle soreness on the evening after the marathon as at least a 4, on a zero-to-ten point scale
- if female, must not be pregnant or breastfeeding, and must be using an acceptable form of contraception
Exclusion Criteria:
- Previous diagnosis of osteoarthritis requiring pain medication therapy
- currently have a major medical illness
- have a history of cardiovascular disease, heat injury (heat exhaustion or heat stroke) or collapse during a running or endurance event
- known hypersensitivity to acetaminophen or ibuprofen
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
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Average change in muscle soreness from baseline for both morning and evening assessments.
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Secondary Outcome Measures
Outcome Measure |
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Average change in muscle soreness from baseline for morning assessments; Average change in muscle soreness from baseline for evening assessments; Average ratings of interference with 1) sleep; 2) morning activity; 3) ability to go for a run
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Publications and helpful links
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Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
May 1, 2003
Study Completion (Actual)
June 1, 2003
Study Registration Dates
First Submitted
October 14, 2005
First Submitted That Met QC Criteria
October 14, 2005
First Posted (Estimate)
October 18, 2005
Study Record Updates
Last Update Posted (Estimate)
June 29, 2011
Last Update Submitted That Met QC Criteria
June 28, 2011
Last Verified
June 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- CR002866
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