Actual Use Trial of Naproxen Sodium (Kiefer AUT)

• ClinicalTrials.gov Identifier: NCT01427803
• Recruitment Status: Completed
• First Posted: September 2, 2011
• Results First Posted: May 20, 2013
• Last Update Posted: October 15, 2015
• Sponsor: Bayer
• Information provided by (Responsible Party): Bayer

Study Description

Brief 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 exceeding the labeled daily dose.

Condition or disease	Intervention/treatment	Phase
Pain	Drug: Naproxen Sodium ER (BAYH6689)	Phase 3

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 778 participants
• Allocation: Randomized
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: An Actual Use Trial In A Simulated OTC Environment of an Extended-Release Over-the-Counter NSAID
• Study Start Date: September 2011
• Actual Primary Completion Date: December 2011
• Actual Study Completion Date: December 2011

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures :

1. Estimated Percentage of Misuse for Non-Therapeutic Reasons [ Time Frame: 28 days ]
   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 :

1. Non-therapeutic Reasons for Misuse [ Time Frame: 28 days ]
   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.
2. Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course [ Time Frame: 28 days ]
   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."
3. Percentage of Participants Took >/= 2 Tablets/Use Day in Any 10 Use Days [ Time Frame: 28 days ]
   Percentage of participants took >/= 2 tablets/use day in any 10 use days thus exceeding the label directions during a treatment course.
4. Percentage of Participants Who Took Product With Mean Daily Use >/= 2 Tablets /Use Day [ Time Frame: 28 days ]
   Percentage of participants who took product with mean daily use >/= 2 tablets /use day thus exceeding the label directions on any use day.
5. Percentage of Participants With at Least One Dosing Occasion Where More Than One Tablet Was Taken [ Time Frame: 28 days ]
   Percentage of participants with at least one dosing occasion where more than one tablet was taken thus exceeding the label directions.
6. Percentage of Dosing Occasions Where More Than One Tablet Was Taken [ Time Frame: 28 days ]
   Percentage of dosing occasions where more than one tablet was taken thus exceeding the label directions.
7. Percentage of Participants Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose [ Time Frame: 28 days ]
   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.
8. Percentage of Dosing Occasions Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose [ Time Frame: 28 days ]
   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

Eligibility Criteria

• Ages Eligible for Study: 12 Years and older (Child, Adult, Older Adult)
• Sexes Eligible for Study: All
• 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

Locations

United States, Alabama

Hoover, Alabama, United States, 35226

McCalla, Alabama, United States, 35111-3406

Pinson, Alabama, United States, 35126

United States, Arizona

Mesa, Arizona, United States, 85202

United States, California

Anaheim, California, United States, 92801

Oceanside, California, United States, 92054

Yorba Linda, California, United States, 92886

United States, Kansas

Overland Park, Kansas, United States, 66209

United States, Maryland

Baltimore, Maryland, United States, 21228

United States, 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

United States, Missouri

Kansas City, Missouri, United States, 64111

Savannah, Missouri, United States, 64485

St. Joseph, Missouri, United States, 64504

United States, New Mexico

Albuquerque, New Mexico, United States, 87104

Albuquerque, New Mexico, United States, 87107

Taos, New Mexico, United States, 87571

United States, 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, 84102

Salt Lake City, Utah, United States, 84121

Syracuse, Utah, United States, 84075

West Jordan, Utah, United States, 84088

United States, Virginia

Montpelier, Virginia, United States, 23192

Richmond, Virginia, United States, 23221

United States, Washington

Bellevue, Washington, United States, 98007

Kenmore, Washington, United States, 98028

Snohomish, Washington, United States, 98290

Sponsors and Collaborators

Bayer

Investigators

• Study Director: Bayer Study Director; Bayer

More Information

• Responsible Party: Bayer
• ClinicalTrials.gov Identifier: NCT01427803
• Other Study ID Numbers: 15647
• First Posted: September 2, 2011
• Results First Posted: May 20, 2013
• Last Update Posted: October 15, 2015
• Last Verified: April 2014

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; Anti-Inflammatory Agents; Antirheumatic Agents; Gout Suppressants; Cyclooxygenase Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action