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Actual Use Trial of Naproxen Sodium (Kiefer AUT)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Bayer
ClinicalTrials.gov Identifier:
NCT01427803
First received: August 31, 2011
Last updated: April 9, 2013
Last verified: April 2013
History of Changes
  Purpose

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.


Condition Intervention Phase
Pain
 Drug: Naproxen Sodium ER (BAYH6689)
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: An Actual Use Trial In A Simulated OTC Environment of an Extended-Release Over-the-Counter NSAID

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Bayer:

Primary Outcome Measures:
  • Estimated Percentage of Misuse for Non-Therapeutic Reasons [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Non-therapeutic Reasons for Misuse [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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.

  • Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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."

  • Percentage of Participants Took >/= 2 Tablets/Use Day in Any 10 Use Days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Percentage of participants took >/= 2 tablets/use day in any 10 use days thus exceeding the label directions during a treatment course.

  • Percentage of Participants Who Took Product With Mean Daily Use >/= 2 Tablets /Use Day [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Percentage of participants who took product with mean daily use >/= 2 tablets /use day thus exceeding the label directions on any use day.

  • Percentage of Participants With at Least One Dosing Occasion Where More Than One Tablet Was Taken [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Percentage of participants with at least one dosing occasion where more than one tablet was taken thus exceeding the label directions.

  • Percentage of Dosing Occasions Where More Than One Tablet Was Taken [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    Percentage of dosing occasions where more than one tablet was taken thus exceeding the label directions.

  • Percentage of Participants Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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.

  • Percentage of Dosing Occasions Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose [ Time Frame: 28 days ] [ Designated as safety issue: No ]
    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


Enrollment: 778
Study Start Date: September 2011
Study Completion Date: December 2011
Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Arm 1 Drug: Naproxen Sodium ER (BAYH6689)
BAYH6689; oral tablet used as needed upon incidence of pain

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01427803

  Show 34 Study Locations
Sponsors and Collaborators
Bayer
Investigators
Study Director: Bayer Study Director Bayer
  More Information

Additional Information:
Click here and search for drug information provided by the FDA.  This link exits the ClinicalTrials.gov site
Click here and search for information on any recalls, market or product safety alerts by the FDA which might have occurred with this product.  This link exits the ClinicalTrials.gov site
Click here to find results for studies related to Bayer Healthcare products.  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Bayer
ClinicalTrials.gov Identifier: NCT01427803     History of Changes
Other Study ID Numbers: 15647
Study First Received: August 31, 2011
Results First Received: February 5, 2013
Last Updated: April 9, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Bayer:
Actual Use Trial

Additional relevant MeSH terms:
Naproxen
Anti-Inflammatory Agents, Non-Steroidal
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Pharmacologic Actions
 Anti-Inflammatory Agents
Therapeutic Uses
Antirheumatic Agents
Gout Suppressants
Cyclooxygenase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Central Nervous System Agents

ClinicalTrials.gov processed this record on May 19, 2013