Status:
COMPLETED
An Effectiveness and Safety Study Comparing Acetaminophen (3900 mg/Day) to Ibuprofen (1200 mg/Day) in the Treatment of Post-Race Muscle Soreness.
Lead Sponsor:
Johnson & Johnson Consumer and Personal Products Worldwide
Conditions:
Pain
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
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.
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 ...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2003
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2003
Estimated Enrollment :
483 Patients enrolled
Trial Details
Trial ID
NCT00240838
Start Date
May 1 2003
End Date
June 1 2003
Last Update
June 29 2011
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