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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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00240851
First Posted: October 18, 2005
Last Update Posted: June 19, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Information provided by (Responsible Party):
Johnson & Johnson Consumer and Personal Products Worldwide
  Purpose
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.

Condition Intervention Phase
Pain Drug: acetaminophen extended release Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Johnson & Johnson Consumer and Personal Products Worldwide:

Primary Outcome Measures:
  • The average change from baseline in muscle soreness on Day 1

Secondary Outcome Measures:
  • Average change from baseline in muscle soreness for both morning and evening assessments, combined and separately; Average ratings of interference with 1) sleep, 2) daily activity, and 3) ability to go for a run

Enrollment: 665
Study Completion Date: February 2004
Arms Assigned Interventions
Experimental: 001
acetaminophen extended release
Drug: acetaminophen extended release

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.
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00240851


Sponsors and Collaborators
Johnson & Johnson Consumer and Personal Products Worldwide
McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
Investigators
Study Director: McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.
  More Information

Responsible Party: Johnson & Johnson Consumer and Personal Products Worldwide
ClinicalTrials.gov Identifier: NCT00240851     History of Changes
Other Study ID Numbers: CR002881
First Submitted: October 14, 2005
First Posted: October 18, 2005
Last Update Posted: June 19, 2015
Last Verified: June 2015

Keywords provided by Johnson & Johnson Consumer and Personal Products Worldwide:
muscle ache
pain
soreness
acetaminophen

Additional relevant MeSH terms:
Acetaminophen
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Antipyretics