NCT00410995

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

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

Enrollment
40

participants targeted

Target at P50-P75 for phase_4 healthy

Timeline
Completed

Started May 2004

Typical duration for phase_4 healthy

Geographic Reach
1 country

1 active site

Status
terminated

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, 2004

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2006

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

December 12, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

December 13, 2006

Completed
Last Updated

October 11, 2007

Status Verified

October 1, 2007

First QC Date

December 12, 2006

Last Update Submit

October 10, 2007

Conditions

Healthy

Keywords

Physically fit volunteers

Outcome Measures

Primary Outcomes (1)

  • Effects on physical performance in terms of maximum oxygen consumption

Interventions

NaproxenDRUG

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Family Practice - CMT

Tulsa, Oklahoma, 74104, United States

Location

MeSH Terms

Interventions

Naproxen

Intervention Hierarchy (Ancestors)

Naphthaleneacetic AcidsNaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Officials

  • LaMont Cavanagh, MD

    University of Oklahoma-Tulsa

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 12, 2006

First Posted

December 13, 2006

Study Start

May 1, 2004

Study Completion

August 1, 2006

Last Updated

October 11, 2007

Record last verified: 2007-10

Locations

US(1)