Actual Use Trial of Naproxen Sodium (Kiefer AUT)

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.

Study Overview

• Status: Completed
• Conditions: Pain
• Intervention / Treatment: Drug: Naproxen Sodium ER (BAYH6689)

• Study Type: Interventional
• Enrollment (Actual): 778
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Hoover, Alabama, United States, 35226
    • McCalla, Alabama, United States, 35111-3406
    • Pinson, Alabama, United States, 35126
  • Arizona
    • Mesa, Arizona, United States, 85202
  • California
    • Anaheim, California, United States, 92801
    • Oceanside, California, United States, 92054
    • Yorba Linda, California, United States, 92886
  • Kansas
    • Overland Park, Kansas, United States, 66209
  • Maryland
    • Baltimore, Maryland, United States, 21228
  • Minnesota
    • Andover, Minnesota, United States, 55304
    • Elk River, Minnesota, United States, 55330
    • Fridley, Minnesota, United States, 55432
    • Northfield, Minnesota, United States, 55057-2434
    • Rosemount, Minnesota, United States, 55068
    • Roseville, Minnesota, United States, 55113
  • Missouri
    • Kansas City, Missouri, United States, 64111
    • Savannah, Missouri, United States, 64485
    • St. Joseph, Missouri, United States, 64504
  • New Mexico
    • Albuquerque, New Mexico, United States, 87104
    • Albuquerque, New Mexico, United States, 87107
    • Taos, New Mexico, United States, 87571
  • Utah
    • Bountiful, Utah, United States, 84010
    • Hurricane, Utah, United States, 84737
    • Layton, Utah, United States, 84041
    • Ogden, Utah, United States, 84401
    • Salt Lake City, Utah, United States, 84121
    • Salt Lake City, Utah, United States, 84102
    • Syracuse, Utah, United States, 84075
    • West Jordan, Utah, United States, 84088
  • Virginia
    • Montpelier, Virginia, United States, 23192
    • Richmond, Virginia, United States, 23221
  • Washington
    • Bellevue, Washington, United States, 98007
    • Kenmore, Washington, United States, 98028
    • Snohomish, Washington, United States, 98290

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 12 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Arm 1	Drug: Naproxen Sodium ER (BAYH6689); BAYH6689; oral tablet used as needed upon incidence of pain

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	28 days
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."	28 days
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.	28 days
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.	28 days
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.	28 days
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.	28 days
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.	28 days
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	28 days

Collaborators and Investigators

• Sponsor: Bayer

Study record dates

Study Major Dates

• Study Start: September 1, 2011
• Primary Completion (Actual): December 1, 2011
• Study Completion (Actual): December 1, 2011

Study Registration Dates

• First Submitted: August 31, 2011
• First Submitted That Met QC Criteria: September 1, 2011
• First Posted (Estimate): September 2, 2011

Study Record Updates

• Last Update Posted (Estimate): October 15, 2015
• Last Update Submitted That Met QC Criteria: September 24, 2015
• Last Verified: April 1, 2014

More Information

Terms related to this study

• Keywords: Actual Use Trial
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Peripheral Nervous System Agents; Enzyme Inhibitors; Analgesics; Sensory System Agents; Anti-Inflammatory Agents, Non-Steroidal; Analgesics, Non-Narcotic; Anti-Inflammatory Agents; Antirheumatic Agents; Cyclooxygenase Inhibitors; Gout Suppressants; Naproxen
• Other Study ID Numbers: 15647