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PainPhase 3Kiefer AUTNCT01427803

Actual Use Trial of Naproxen Sodium

A Phase 3 study testing Naproxen Sodium ER (BAYH6689) in people with Pain, run by Bayer at 34 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

An actual use trial to demonstrate that consumers will not exceed the labeled daily dose of Aleve 24 Hour at an unacceptable rate. Two aspects of consumer use will be evaluated: 1) the frequency at which consumers exceed the label-defined daily dose, thus putting themselves at clinical risk, and 2) the reasons for… Read more about this study

Who is it for?
Ages 12 years and olderHealthy volunteers can take part
Conditions the study is for
Pain
What is being tested?
Naproxen Sodium ER (BAYH6689)
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
778 participants
Where
34 sitesUnited States
Study dates
Sep 2011to Dec 2011
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 12 years and older
  • All sexes
  • Healthy volunteers accepted
  • Child, Adult, Older adult

Who may be able to join

  • At least 12 years of age
  • Report taking OTC analgesics for pain on at least 5 days in the last month
  • Report having had pain at least once in the last 3 months lasting longer than 12 hours or that they believe would have lasted longer than 12 hours if they had not treated it
  • Able to read and understand English
  • Provide written informed consent (subjects 12-17 years of age provide written assent and/or parent or legal guardian provide written consent)
  • Provide contact information
  • Purchase the investigational product

Who cannot join

  • Have participated in a trial involving OTC analgesics in the last 6 months
  • They or someone else in the household work for a market research company, an advertising agency, a public relations firm, a pharmaceutical company, as a healthcare professional, or as part of a health care practice (eliminated for reasons of confidentiality or increased awareness of drugs and their labels)
  • Have a history of known allergies to NSAIDs (i.e., naproxen, ibuprofen, aspirin, etc.)
  • Have a history of heart surgery in the last 60 days or plans for heart surgery in the next 60 days
  • (Female subjects) are pregnant or breastfeeding

Trial locations and contacts

34 sites in 1 country.

34 sites in 1 country

United States34 sites

  • Study site

    Albuquerque, New Mexico, 87104

  • Study site

    Albuquerque, New Mexico, 87107

  • Study site

    Anaheim, California, 92801

  • Study site

    Andover, Minnesota, 55304

  • Study site

    Baltimore, Maryland, 21228

  • Study site

    Bellevue, Washington, 98007

  • Study site

    Bountiful, Utah, 84010

  • Study site

    Elk River, Minnesota, 55330

  • Study site

    Fridley, Minnesota, 55432

  • Study site

    Hoover, Alabama, 35226

  • Study site

    Hurricane, Utah, 84737

  • Study site

    Kansas City, Missouri, 64111

  • Study site

    Kenmore, Washington, 98028

  • Study site

    Layton, Utah, 84041

  • Study site

    McCalla, Alabama, 35111-3406

  • Study site

    Mesa, Arizona, 85202

  • Study site

    Montpelier, Virginia, 23192

  • Study site

    Northfield, Minnesota, 55057-2434

  • Study site

    Oceanside, California, 92054

  • Study site

    Ogden, Utah, 84401

  • Study site

    Overland Park, Kansas, 66209

  • Study site

    Pinson, Alabama, 35126

  • Study site

    Richmond, Virginia, 23221

  • Study site

    Rosemount, Minnesota, 55068

  • Study site

    Roseville, Minnesota, 55113

  • Study site

    Saint Joseph, Missouri, 64504

  • Study site

    Salt Lake City, Utah, 84102

  • Study site

    Salt Lake City, Utah, 84121

  • Study site

    Savannah, Missouri, 64485

  • Study site

    Snohomish, Washington, 98290

  • Study site

    Syracuse, Utah, 84075

  • Study site

    Taos, New Mexico, 87571

  • Study site

    West Jordan, Utah, 84088

  • Study site

    Yorba Linda, California, 92886

Other trials in United States

About this study

Official title: An Actual Use Trial In A Simulated OTC Environment of an Extended-Release Over-the-Counter NSAID

An actual use trial to demonstrate that consumers will not exceed the labeled daily dose of Aleve 24 Hour at an unacceptable rate. Two aspects of consumer use will be evaluated: 1) the frequency at which consumers exceed the label-defined daily dose, thus putting themselves at clinical risk, and 2) the reasons for exceeding the labeled daily dose.

Conditions
Pain
Being tested
Naproxen Sodium ER (BAYH6689)
Keywords
Actual Use Trial
Medical subject headings
Pain

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Naproxen Sodium ER (BAYH6689)Drug

    BAYH6689; oral tablet used as needed upon incidence of pain

Study groups in NCT01427803
Study groupRoleWhat they receive
Arm 1ExperimentalNot described
Receives: Drug: Naproxen Sodium ER (BAYH6689)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Estimated Percentage of Misuse for Non-Therapeutic Reasons

    The primary objective of this trial was to determine the percentage of non-therapeutic misuse. Two aspects of consumer use of Aleve 24 Hour were examined: the frequency at which consumers exceeded the label-defined daily dose modified by those who did so for non-therapeutic reasons.

    Measured: 28 days

Secondary outcomes (8)

  1. Non-therapeutic Reasons for Misuse

    Those subjects in the Reasons for Misuse Cohort who did not state misuse due to need for additional pain relief were categorized to Non-therapeutic misuse.

    Measured: 28 days

  2. Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course

    This endpoint was an assessment of whether the rate of non-therapeutic misuse exceeded the pre-defined acceptable threshold for non-therapeutic misuse. The difference lay in the estimation of misuse in the Patterns of Use Cohort by using 10-day treatment courses rather than by "use day". A treatment course for each subject began on the first day they recorded taking one or more tablets which was followed by nine consecutive "evaluable days."

    Measured: 28 days

  3. Percentage of Participants Took >/= 2 Tablets/Use Day in Any 10 Use Days

    Percentage of participants took >/= 2 tablets/use day in any 10 use days thus exceeding the label directions during a treatment course.

    Measured: 28 days

  4. Percentage of Participants Who Took Product With Mean Daily Use >/= 2 Tablets /Use Day

    Percentage of participants who took product with mean daily use >/= 2 tablets /use day thus exceeding the label directions on any use day.

    Measured: 28 days

  5. Percentage of Participants With at Least One Dosing Occasion Where More Than One Tablet Was Taken

    Percentage of participants with at least one dosing occasion where more than one tablet was taken thus exceeding the label directions.

    Measured: 28 days

  6. Percentage of Dosing Occasions Where More Than One Tablet Was Taken

    Percentage of dosing occasions where more than one tablet was taken thus exceeding the label directions.

    Measured: 28 days

  7. Percentage of Participants Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose

    Percentage of participants where a dose was taken less than 22 hours after the most recent previous dose thus exceeding the label directions. 22 hrs was chosen to allow for some imprecision in subjects' recollection.

    Measured: 28 days

  8. Percentage of Dosing Occasions Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose

    Percentage of dosing occasions where a dose was taken less than 22 hours after the most recent previous dose. 22 hrs was chosen to allow for some imprecision in subjects' recollection

    Measured: 28 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted2 Sep 2011 (estimated)
  2. Study startSep 2011
  3. Primary completionDec 2011
  4. Study completionDec 2011

Resources

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Single group
Masking
None (open label)
Enrolment
778 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01427803
Sponsor's protocol ID
15647
Acronym
Kiefer AUT
Status last verified
Apr 2014
First submitted
31 Aug 2011
Last updated
15 Oct 2015
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Naproxen Sodium ER (BAYH6689) in people with Pain, run by Bayer at 34 sites 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 15 Oct 2015. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 34 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 May 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Estimated Percentage of Misuse for Non-Therapeutic Reasons (time frame: 28 days). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01427803.

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 15 Oct 2015.

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