Actual Use Trial of Naproxen Sodium

Pain Clinical Trial

— Kiefer AUT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01427803
• Other study ID #: 15647
• Status: Completed
• Phase: Phase 3
• First received: August 31, 2011
• Last updated: September 24, 2015
• Start date: September 2011
• Est. completion date: December 2011

Study information

• Verified date: April 2014
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical 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 exceeding the labeled daily dose.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 778
• Est. completion date: December 2011
• Est. primary completion date: December 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years and older

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Naproxen Sodium ER (BAYH6689)
BAYH6689; oral tablet used as needed upon incidence of pain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No
Secondary	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	No

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