An Effectiveness and Safety Study Comparing Acetaminophen (3900 mg/Day) to Ibuprofen (1200 mg/Day) in the Treatment of Post-Race Muscle Soreness.

• Status: Completed
• Trial end date: 2003-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Treatments: Acetaminophen; Ibuprofen

Criteria

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