Effects of Naproxen on Physical Performance

October 10, 2007 updated by: University of Oklahoma
The purpose of this study is to determine the effect of daily use of Naproxen (a commonly used over-the-counter NSAID) on the physical performance of athletes, as measured by maximum oxygen consumption.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Oklahoma
      • Tulsa, Oklahoma, United States, 74104
        • Family Practice - CMT

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 30 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Age equal to or greater than18 years of age
  2. No history of allergy or adverse reaction to any NSAID
  3. No use of any NSAID in past 2 weeks
  4. No history of peptic ulcer disease (PUD), gastroesophageal disease (GERD), or gastritis
  5. No major medical history including but not limited to diabetes, hypertension, asthma, kidney disease and coronary artery disease
  6. Currently not taking any medication including oral contraceptives

Exclusion Criteria:

  1. Age < 18 years of age
  2. History of allergy or adverse reaction to any NSAID
  3. Use of any NSAID in past 2 weeks
  4. History of a bleeding disorder
  5. History of PUD, GERD, or gastritis
  6. Pregnant
  7. A medical history of diabetes, hypertension, asthma, kidney disease or coronary artery disease
  8. Taking any medication including oral contraceptives

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Effects on physical performance in terms of maximum oxygen consumption

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oklahoma

Investigators

  • Principal Investigator: LaMont Cavanagh, MD, University Of Oklahoma-Tulsa

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2004

Study Completion (Actual)

August 1, 2006

Study Registration Dates

First Submitted

December 12, 2006

First Submitted That Met QC Criteria

December 12, 2006

First Posted (Estimate)

December 13, 2006

Study Record Updates

Last Update Posted (Estimate)

October 11, 2007

Last Update Submitted That Met QC Criteria

October 10, 2007

Last Verified

October 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 11186 (DAIDS ES Registry Number)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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