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

Johnson & Johnson (J&J) logo

Johnson & Johnson (J&J)

Status and phase

Completed
Phase 4

Conditions

Pain

Treatments

Drug: acetaminophen extended release

Study type

Interventional

Funder types

Industry

Identifiers

NCT00240851
CR002881

Details and patient eligibility

About

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.

Full 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.

Enrollment

665 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

665 participants in 1 patient group

001
Experimental group
Description:
acetaminophen extended release
Treatment:
Drug: acetaminophen extended release

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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