An Effectiveness and Safety Study of Acetaminophen Extended Release Caplets in Treating Muscle Aches and Soreness That Occur After a Marathon Race

• Status: Completed
• Trial end date: 2004-02-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide
• Collaborator: McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
• Treatments: Acetaminophen

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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