Effects of Naproxen on Physical Performance

Healthy Clinical Trial

Official title:

Effects of Naproxen on Physical Performance

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT00410995
• Other study ID #: 11186
• Status: Terminated
• Phase: Phase 4
• First received: December 12, 2006
• Last updated: October 10, 2007
• Start date: May 2004
• Est. completion date: August 2006

Study information

• Verified date: October 2007
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 40
• Est. completion date: August 2006
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 30 Years

Eligibility

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 Design

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Healthy

Intervention

Drug:
• Naproxen

Locations

Country	Name	City	State
United States	Family Practice - CMT	Tulsa	Oklahoma

Sponsors (1)

Lead Sponsor	Collaborator
University of Oklahoma

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Effects on physical performance in terms of maximum oxygen consumption