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

Tracking Information

• First Submitted Date: August 31, 2011
• First Posted Date: September 2, 2011
• Results First Submitted Date: February 5, 2013
• Results First Posted Date: May 20, 2013
• Last Update Posted Date: October 15, 2015
• Study Start Date: September 2011
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 9, 2013)

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.

• Original Primary Outcome Measures (submitted: September 1, 2011): Comparing the rate of non-therapeutic misuse to the pre-defined acceptable threshold for non-therapeutic misuse. [ Time Frame: After 28 days ]

Current Secondary Outcome Measures (submitted: April 9, 2013)

• 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.
• 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."
• 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.
• 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.
• 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.
• 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.
• 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.
• 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

Original Secondary Outcome Measures (submitted: September 1, 2011)

• The proportion of subjects and dosing occasions with greater than one tablet taken per dose [ Time Frame: After 28 days ]
• The proportion of subjects and dosing occasions with a dose taken less than 22 hours after the most recent previous dose. [ Time Frame: After 28 days ]
• The proportion of subjects taking ≥ 2 tablets per day in any 10-days (prescription level dose). [ Time Frame: After 28 days ]
• Incidence of Adverse Events (AEs) in the Safety Population. [ Time Frame: After 28 days ]

• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Actual Use Trial of Naproxen Sodium
• Official Title: An Actual Use Trial In A Simulated OTC Environment of an Extended-Release Over-the-Counter NSAID
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 3
• Study Design: Allocation: Randomized; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment
• Condition: Pain

Intervention

Drug: Naproxen Sodium ER (BAYH6689)

BAYH6689; oral tablet used as needed upon incidence of pain

Study Arms

Experimental: Arm 1

Intervention: Drug: Naproxen Sodium ER (BAYH6689)

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: April 9, 2013): 778
• Original Estimated Enrollment (submitted: September 1, 2011): 1400
• Actual Study Completion Date: December 2011
• Actual Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 12 Years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT01427803
• Other Study ID Numbers: 15647
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: Bayer
• Original Responsible Party: Head Clinical and Medical Affairs, Bayer Consumer Care Inc.
• Current Study Sponsor: Bayer
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Study Director: Bayer Study Director; Bayer

• PRS Account: Bayer
• Verification Date: April 2014