NCT00240851

Brief 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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
665

participants targeted

Target at P75+ for phase_4 pain

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Completion

Last participant's last visit for all outcomes

February 1, 2004

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

October 14, 2005

Completed
4 days until next milestone

First Posted

Study publicly available on registry

October 18, 2005

Completed
Last Updated

June 19, 2015

Status Verified

June 1, 2015

First QC Date

October 14, 2005

Last Update Submit

June 18, 2015

Conditions

Pain

Keywords

muscle achepainsorenessacetaminophen

Outcome Measures

Primary Outcomes (1)

  • The average change from baseline in muscle soreness on Day 1

Secondary Outcomes (1)

  • 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

Study Arms (1)

001

EXPERIMENTAL

acetaminophen extended release

Drug: acetaminophen extended release

Interventions

acetaminophen extended releaseDRUG
001

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

PainMyalgia

Condition Hierarchy (Ancestors)

Neurologic ManifestationsSigns and SymptomsPathological Conditions, Signs and SymptomsMuscular DiseasesMusculoskeletal DiseasesNeuromuscular DiseasesNervous System DiseasesMusculoskeletal Pain

Study Officials

  • McNeil Consumer & Specialty Pharmaceuticals, a Division of Mc Neil-PPC, Inc. Clinical Trial

    McNeil Consumer & Specialty Pharmaceuticals, a Division of McNeil-PPC, Inc.

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 14, 2005

First Posted

October 18, 2005

Study Completion

February 1, 2004

Last Updated

June 19, 2015

Record last verified: 2015-06