Clinical trial NCT01427803: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Pain
Keywords: Actual Use Trial
Lead sponsor: Bayer
Sponsor class: INDUSTRY
First posted: 2011-09-02
Enrollment: 778
Sex: ALL
Minimum age (years): 12
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Estimated Percentage of Misuse for Non-Therapeutic Reasons
timeFrame: 28 days
Secondary outcomes:
measure: Non-therapeutic Reasons for Misuse
timeFrame: 28 days
measure: Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course
timeFrame: 28 days
measure: Percentage of Participants Took >/= 2 Tablets/Use Day in Any 10 Use Days
timeFrame: 28 days
measure: Percentage of Participants Who Took Product With Mean Daily Use >/= 2 Tablets /Use Day
timeFrame: 28 days
measure: Percentage of Participants With at Least One Dosing Occasion Where More Than One Tablet Was Taken
timeFrame: 28 days
measure: Percentage of Dosing Occasions Where More Than One Tablet Was Taken
timeFrame: 28 days
measure: Percentage of Participants Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose
timeFrame: 28 days
measure: Percentage of Dosing Occasions Where a Dose Was Taken Less Than 22 Hours After the Most Recent Previous Dose
timeFrame: 28 days
Other outcomes:
Locations:
city: Hoover
country: United States
state: Alabama
city: McCalla
country: United States
state: Alabama
city: Pinson
country: United States
state: Alabama
city: Mesa
country: United States
state: Arizona
city: Anaheim
country: United States
state: California
city: Oceanside
country: United States
state: California
city: Yorba Linda
country: United States
state: California
city: Overland Park
country: United States
state: Kansas
city: Baltimore
country: United States
state: Maryland
city: Andover
country: United States
state: Minnesota
city: Elk River
country: United States
state: Minnesota
city: Fridley
country: United States
state: Minnesota
city: Northfield
country: United States
state: Minnesota
city: Rosemount
country: United States
state: Minnesota
city: Roseville
country: United States
state: Minnesota
city: Kansas City
country: United States
state: Missouri
city: Savannah
country: United States
state: Missouri
city: St. Joseph
country: United States
state: Missouri
city: Albuquerque
country: United States
state: New Mexico
city: Albuquerque
country: United States
state: New Mexico
city: Taos
country: United States
state: New Mexico
city: Bountiful
country: United States
state: Utah
city: Hurricane
country: United States
state: Utah
city: Layton
country: United States
state: Utah
city: Ogden
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Salt Lake City
country: United States
state: Utah
city: Syracuse
country: United States
state: Utah
city: West Jordan
country: United States
state: Utah
city: Montpelier
country: United States
state: Virginia
city: Richmond
country: United States
state: Virginia
city: Bellevue
country: United States
state: Washington
city: Kenmore
country: United States
state: Washington
city: Snohomish
country: United States
state: Washington
Study officials:
affiliation: Bayer
name: Bayer Study Director
role: STUDY_DIRECTOR
References: