NCT00240838

Brief Summary

The purpose of this study is to compare the effectiveness and safety of acetaminophen extended release caplets and ibuprofen in relieving the muscle 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
483

participants targeted

Target at P75+ for phase_4 pain

Timeline
Completed

Started May 2003

Shorter than P25 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 Start

First participant enrolled

May 1, 2003

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2003

Completed
2.4 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 29, 2011

Status Verified

June 1, 2011

First QC Date

October 14, 2005

Last Update Submit

June 28, 2011

Conditions

Pain

Keywords

muscle sorenesspain, acetaminophenibuprofen

Outcome Measures

Primary Outcomes (1)

  • Average change in muscle soreness from baseline for both morning and evening assessments.

Secondary Outcomes (1)

  • Average change in muscle soreness from baseline for morning assessments; Average change in muscle soreness from baseline for evening assessments; Average ratings of interference with 1) sleep; 2) morning activity; 3) ability to go for a run

Interventions

acetaminophen extended release capletsDRUG

Eligibility Criteria

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

You may qualify if:

  • Patients must complete the marathon
  • be able to swallow the study medication
  • comply with study requirements regarding the use of any other pain medications before, during or after the marathon
  • rate their muscle soreness on the evening after the marathon as at least a 4, on a zero-to-ten point scale
  • if female, must not be pregnant or breastfeeding, and must be using an acceptable form of contraception

You may not qualify if:

  • Previous diagnosis of osteoarthritis requiring pain medication therapy
  • currently have a major medical illness
  • have a history of cardiovascular disease, heat injury (heat exhaustion or heat stroke) or collapse during a running or endurance event
  • known hypersensitivity to acetaminophen or ibuprofen

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

Study Record Dates

First Submitted

October 14, 2005

First Posted

October 18, 2005

Study Start

May 1, 2003

Study Completion

June 1, 2003

Last Updated

June 29, 2011

Record last verified: 2011-06