Effects of Naproxen on Physical Performance

This study has been terminated.

( Study never initiated. )

First Received: December 12, 2006 Last Updated: October 10, 2007 History of Changes

Sponsor:	University of Oklahoma
Information provided by:	University of Oklahoma
ClinicalTrials.gov Identifier:	NCT00410995

Purpose

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.

Condition	Intervention	Phase
Healthy	Drug: Naproxen	Phase IV

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Efficacy Study
Official Title:	Effects of Naproxen on Physical Performance

Resource links provided by NLM:

Drug Information available for: Naproxen Naproxen sodium

U.S. FDA Resources

Further study details as provided by University of Oklahoma:

Primary Outcome Measures:

Effects on physical performance in terms of maximum oxygen consumption

Estimated Enrollment:	40
Study Start Date:	May 2004
Study Completion Date:	August 2006

Eligibility

Ages Eligible for Study:	18 Years to 30 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00410995

Locations

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

Sponsors and Collaborators

University of Oklahoma

Investigators

Principal Investigator:

LaMont Cavanagh, MD

University of Oklahoma-Tulsa

More Information

No publications provided

Study ID Numbers:	11186
Study First Received:	December 12, 2006
Last Updated:	October 10, 2007
ClinicalTrials.gov Identifier:	NCT00410995 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Oklahoma:

Physically fit volunteers

Additional relevant MeSH terms:

Anti-Inflammatory Agents
Naproxen
Molecular Mechanisms of Pharmacological Action
Physiological Effects of Drugs
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Gout Suppressants
Pharmacologic Actions

Analgesics, Non-Narcotic
Sensory System Agents
Therapeutic Uses
Anti-Inflammatory Agents, Non-Steroidal
Analgesics
Peripheral Nervous System Agents
Antirheumatic Agents
Central Nervous System Agents

ClinicalTrials.gov processed this record on February 08, 2010