Study Completed

Pain

Bayer Identifier:

13129

ClinicalTrials.gov Identifier:

NCT00751400

EudraCT Number:

2014-005268-13

EU CT Number:

Not Available

Naproxen Sodium Extended-Release Actual Use Study

Trial purpose

The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment.

Key Participants Requirements

Sex

Both

Age

12 Years

Inclusion Criteria
- Self report use of Over The Counter (OTC) analgesics
- Able to read and understand English
- Provide written informed consent (subjects 12-
17 years of age provide written as sent and/ or
parent or legal guardian provide written
consent)
- Purchase the investigational product
Exclusion Criteria
- Have participated in a study involving OTC
analgesics in the last 12 months
- They or someone else in the household work
for a market research company, an advertising
agency, a public relations firm, pharmaceutical
company, as a healthcare professional, or as
part of a health care practice
- Have a history of known allergies to nonsteroidal anti-inflammatory drugs (NSAIDs)
(i.e., Naproxen, Ibuprofen, etc) or Aspirin
- 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

Trial summary

Enrollment Goal

497

Trial Dates

July 2008 - November 2008

Phase

Phase 3

Could I Receive a placebo

Products

Aleve (Naproxen Sodium ER, BAY117031)

Accepts Healthy Volunteer

Where to participate

Status	Institution	Location
Completed	Cub Pharmacy	St. Louis Park, 55426, United States
Completed	Goodrich Pharmacy	Blaine, 55443, United States
Completed	Kerr Drug	Raleigh, 27606, United States
Completed	The Medicine Shoppe	Bountiful, 84010, United States
Completed	The Apothecary Shoppe	Salt Lake City, 84102, United States
Completed	Coast Compounding Pharmacy	Oceanside, 92054, United States
Completed	Kussler's Pharmacy	Snohomish, 98290, United States
Completed	Ostrom Drugs	Kenmore, 98028, United States
Completed	Manhattan Drug Store	Seattle, 98148, United States
Completed	Dryden Drug Company	Belton, 64012, United States
Completed	Countryside Pharmacy	Savannah, 64485, United States
Completed	Stevenson Family Pharmacy	St. Joseph, 64504, United States
Completed	Stark Pharmacy	Overland Park, 66209, United States
Completed	Medical Arts Rexall Pharmacy	Anaheim, 92801, United States
Completed	Via Verde Pharmacy	San Dimas, 91773, United States
Completed	Goodrich Pharmacy	St. Francis, 55070, United States
Completed	Goodrich Pharmacy	Anoka, 55303, United States
Completed	Kemper Drug	Elk River, 55330, United States
Completed	Kerr Drug	Chapel Hill, 27514, United States
Completed	Kerr HealthCare Center	Raleigh, 27612, United States
Completed	Kroger Pharmacy	Cary, 27513, United States
Completed	The Medicine Shoppe	Ogden, 84401, United States
Completed	Island View Pharmacy	Syracuse, 84075, United States
Completed	Family Plaza Pharmacy	West Jordan, 84088, United States

Primary Outcome

Use Days With One or More Misuse Occasions
Time Frame:
1 month
Safety Issue:
No

Secondary Outcome

Dosing Occasions With One and More Than One Tablet Taken
Time Frame:
1 month
Safety Issue:
No
Use days with and without next dose less than 22 hours later
Time Frame:
1 month
Safety Issue:
No
Number of subjects with and without more than one tablet taken per dose
Time Frame:
1 month
Safety Issue:
No
Number of subjects with and without next dose less than 22 hours later
Time Frame:
1 month
Safety Issue:
No
Number of subjects with and without more than 660 mg at least once
Time Frame:
1 month
Safety Issue:
No
Average Daily Dose
Time Frame:
1 month
Safety Issue:
No
Number of subjects that have taken study drug on more than 10 consecutive days and not on more than 10 consecutive days
Time Frame:
1 month
Safety Issue:
No
Number of Total Dosing Occasions Per Subject
Time Frame:
1 month
Safety Issue:
No
Number of Dosing Occasions Per Subject That Exceeded 660 mg
Time Frame:
1 month
Safety Issue:
No

Trial design

An Open Label, Actual Use Study in Consumers Taking an Extended-Release Over the Counter NSAID in a Naturalistic Setting

Trial Type

Interventional

Intervention Type

Drug

Trial Purpose

Other

Allocation

Non-randomized

Blinding

Open Label

Assignment

Single Group Assignment

Trial Arms

Additional Information

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