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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

665 participants

Study Classification

INTERVENTIONAL

Study Completion Date

2004-02-29

Brief Summary

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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.

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Detailed Description

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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

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Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Study Groups

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001

acetaminophen extended release

Group Type EXPERIMENTAL

acetaminophen extended release

Intervention Type DRUG

Interventions

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acetaminophen extended release

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No