HealthyPhase 4NCT00410995
Effects of Naproxen on Physical Performance
A Phase 4 study testing Naproxen in people with Healthy, run by University of Oklahoma at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- Naproxen
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- May 2004to Aug 2006
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
- Conditions
- Healthy
- Being tested
- Naproxen
- Keywords
- Physically fit volunteers
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaproxenDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Effects on physical performance in terms of maximum oxygen consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Dec 2006 (estimated)
- Study startMay 2004
- Study completionAug 2006
Why it stopped: Study never initiated.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by University of OklahomaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants
Sponsor and investigators
- Lead sponsor
- University of Oklahoma
- Sponsor type
- University, hospital or other
- Investigators
- LaMont Cavanagh, MD, Principal investigator, University of Oklahoma-Tulsa
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00410995
- Sponsor's protocol ID
- 11186
- Status last verified
- Oct 2007
- First submitted
- 12 Dec 2006
- Last updated
- 11 Oct 2007
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Naproxen on Physical Performance
- ClinicalTrials.gov ID
- NCT00410995
- Acronym / sponsor ID
- 11186
- Conditions
- Healthy
- Keywords
- Physically fit volunteers
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Study never initiated.
- Enrolment
- 40 participants
- Lead sponsor
- University of OklahomaUniversity, hospital or other
- Study start
- May 2004
- Study completion
- Aug 2006 (actual)
- First posted
- 13 Dec 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Naproxen | Drug | – |
Primary outcome
Effects on physical performance in terms of maximum oxygen consumption
Results and safety
The study was stopped early (reason given: Study never initiated.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2007.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LaMont Cavanagh, MD principal investigator
University of Oklahoma-Tulsa
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Naproxen in people with Healthy, run by University of Oklahoma at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 11 Oct 2007. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Study never initiated.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Effects on physical performance in terms of maximum oxygen consumption. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Oct 2007.