Trial Condition(s):

Pain

Naproxen Sodium Extended-Release Actual Use Study

Bayer Identifier:

13129

ClinicalTrials.gov Identifier:

NCT00751400

EudraCT Number:

2014-005268-13

Study Completed

Trial Purpose

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

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
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Phase
3
Could I receive a placebo?
No
Products
Aleve (Naproxen Sodium ER, BAY117031)
Accepts Healthy Volunteers
No

Where to Participate

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Locations
Status
LocationsStatus
Locations

Cub Pharmacy

St. Louis Park, United States, 55426

Status
Completed
 
Locations

Goodrich Pharmacy

Blaine, United States, 55443

Status
Completed
 
Locations

Kerr Drug

Raleigh, United States, 27606

Status
Completed
 
Locations

The Medicine Shoppe

Bountiful, United States, 84010

Status
Completed
 
Locations

The Apothecary Shoppe

Salt Lake City, United States, 84102

Status
Completed
 
Locations

Coast Compounding Pharmacy

Oceanside, United States, 92054

Status
Completed
 
Locations

Kussler's Pharmacy

Snohomish, United States, 98290

Status
Completed
 
Locations

Ostrom Drugs

Kenmore, United States, 98028

Status
Completed
 
Locations

Manhattan Drug Store

Seattle, United States, 98148

Status
Completed
 
Locations

Dryden Drug Company

Belton, United States, 64012

Status
Completed
 
Locations

Countryside Pharmacy

Savannah, United States, 64485

Status
Completed
 
Locations

Stevenson Family Pharmacy

St. Joseph, United States, 64504

Status
Completed
 
Locations

Stark Pharmacy

Overland Park, United States, 66209

Status
Completed
 
Locations

Medical Arts Rexall Pharmacy

Anaheim, United States, 92801

Status
Completed
 
Locations

Via Verde Pharmacy

San Dimas, United States, 91773

Status
Completed
 
Locations

Goodrich Pharmacy

St. Francis, United States, 55070

Status
Completed
 
Locations

Goodrich Pharmacy

Anoka, United States, 55303

Status
Completed
 
Locations

Kemper Drug

Elk River, United States, 55330

Status
Completed
 
Locations

Kerr Drug

Chapel Hill, United States, 27514

Status
Completed
 
Locations

Kerr HealthCare Center

Raleigh, United States, 27612

Status
Completed
 
Locations

Kroger Pharmacy

Cary, United States, 27513

Status
Completed
 
Locations

The Medicine Shoppe

Ogden, United States, 84401

Status
Completed
 
Locations

Island View Pharmacy

Syracuse, United States, 84075

Status
Completed
 
Locations

Family Plaza Pharmacy

West Jordan, United States, 84088

Status
Completed
 

Trial Design