Trial Condition(s):

Pain

Actual Use Trial of Naproxen Sodium (Kiefer AUT)

Bayer Identifier:

15647

ClinicalTrials.gov Identifier:

NCT01427803

EudraCT Number:

Not Available

Study Completed

Trial Purpose

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.

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

Trial Summary

Enrollment Goal
778
Trial Dates
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Phase
3
Could I receive a placebo?
No
Products
Aleve (Naproxen Sodium ER, BAY117031)
Accepts Healthy Volunteers
Yes

Where to Participate

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Locations
Status
LocationsStatus
Locations

Countryside Pharmacy

Savannah, United States, 64485

Status
Completed
 
Locations

Northfield Pharmacy

Northfield, United States, 55057-2434

Status
Completed
 
Locations

Ostrom Drugs

Kenmore, United States, 98028

Status
Completed
 
Locations

The Medicine Shoppe

Bountiful, United States, 84010

Status
Completed
 
Locations

Goodrich Pharmacy

Fridley, United States, 55432

Status
Completed
 
Locations

Pinson Discount Drugs

Pinson, United States, 35126

Status
Completed
 
Locations

The Medicine Shoppe

Ogden, United States, 84401

Status
Completed
 
Locations

Duran Central Pharmacy

Albuquerque, United States, 87104

Status
Completed
 
Locations

Hurricane Family Pharmacy

Hurricane, United States, 84737

Status
Terminated
 
Locations

Kussler's Pharmacy

Snohomish, United States, 98290

Status
Completed
 
Locations

Setzer Pharmacy

Roseville, United States, 55113

Status
Completed
 
Locations

Family Plaza Pharmacy

West Jordan, United States, 84088

Status
Completed
 
Locations

Stevenson Family Pharmacy

St. Joseph, United States, 64504

Status
Completed
 
Locations

Community Clinical Pharmacy

Mesa, United States, 85202

Status
Completed
 
Locations

Albers Medical Pharmacy

Kansas City, United States, 64111

Status
Completed
 
Locations

Catonsville Pharmacy

Baltimore, United States, 21228

Status
Completed
 
Locations

Northview Pharmacy

Layton, United States, 84041

Status
Completed
 
Locations

Lafayette Pharmacy

Richmond, United States, 23221

Status
Completed
 
Locations

Pharmacy at the Pig

McCalla, United States, 35111-3406

Status
Completed
 
Locations

Robert's Discount Pharmacy

Hoover, United States, 35226

Status
Completed
 
Locations

Taos Pharmacy

Taos, United States, 87571

Status
Completed
 
Locations

B & B Pharmacy

Yorba Linda, United States, 92886

Status
Completed
 
Locations

The Medicine Center

Salt Lake City, United States, 84121

Status
Completed
 
Locations

The Apothecary Shoppe

Salt Lake City, United States, 84102

Status
Completed
 
Locations

Rxtra Care U & I

Bellevue, United States, 98007

Status
Terminated
 
Locations

Island View Pharmacy

Syracuse, United States, 84075

Status
Completed
 
Locations

Pharmacy Plus

Albuquerque, United States, 87107

Status
Completed
 
Locations

Stark Pharmacy

Overland Park, United States, 66209

Status
Completed
 
Locations

Goodrich Pharmacy

Andover, United States, 55304

Status
Completed
 
Locations

Kemper Drug

Elk River, United States, 55330

Status
Completed
 
Locations

Coast Compounding Pharmacy

Oceanside, United States, 92054

Status
Completed
 
Locations

Montpelier Pharmacy

Montpelier, United States, 23192

Status
Completed
 
Locations

Cub Pharmacy

Rosemount, United States, 55068

Status
Completed
 
Locations

Medical Arts Rexall Pharmacy

Anaheim, United States, 92801

Status
Completed
 

Trial Design