NCT00240851

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

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating Acetaminophen Extended Release Caplets (3900 mg/Day) in the Treatment of Post-Race Muscle Aching and Pain (Soreness)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 665 (actual)
• Sponsor: Johnson & Johnson Consumer and Personal Products Worldwide · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 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 four days) or placebo (two placebo caplets taken three times a day, for four days). The primary measurement of efficacy is the average change from baseline in muscle soreness, on Day 1, the day of the marathon. Safety assessments consist of monitoring adverse events, and a physical examination at the screening visit, including vital signs, weight, a medical history review, and a urine pregnancy test for females of childbearing potential. The hypothesis of the study is that acetaminophen is more effective than placebo in the relief of post-race muscle aching and pain (soreness) score on the evening of the race. Two acetaminophen 650 mg extended release caplets, taken by mouth, three times a day over a four day period or two placebo caplets, taken by mouth, three times a day over a four day period.

Conditions

• Pain

Interventions

Type	Name	Description
DRUG	acetaminophen extended release

Timeline

• Completion: 2004-02-01
• First posted: 2005-10-18
• Last updated: 2015-06-19