Trial Condition(s):

Pain

Self Selection Trial of Naproxen Sodium (KEIFER SST)

Bayer Identifier:

15833

ClinicalTrials.gov Identifier:

NCT01383486

EudraCT Number:

2014-005305-20

Study Completed

Trial Purpose

A pilot trial to demonstrate that consumers can appropriately select Aleve 24 Hour for their own use based on expected duration of pain greater than 12 hours.

Inclusion Criteria
- At least 12 years of age
        - Report taking at least one dose of Over-the-counter (OTC) analgesic for pain in the past month
        - 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
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 Nonsteroidal Antiinflammatory Drugs (NSAIDs) (i.e., naproxen, ibuprofen, acetaminophen, 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 who have a positive urine pregnancy test or who are breastfeeding.

Trial Summary

Enrollment Goal
253
Trial Dates
black-arrow
Phase
3
Could I receive a placebo?
No
Products
Aleve (Naproxen Sodium ER, BAY117031)
Accepts Healthy Volunteers
Yes

Where to Participate

Loading...
Locations
Status
LocationsStatus
Locations

B & B Pharmacy

Yorba Linda, United States, 92886

Status
Completed
 
Locations

Medical Arts Rexall Pharmacy

Anaheim, United States, 92801

Status
Completed
 
Locations

Pill Box Pharmacy

Pembroke Pines, United States, 33026

Status
Completed
 
Locations

Wynn's Pharmacy

Griffin, United States, 30224

Status
Completed
 
Locations

Setzer Pharmacy

Roseville, United States, 55113

Status
Completed
 
Locations

Goodrich Pharmacy

Andover, United States, 55304

Status
Completed
 
Locations

The Medicine Shoppe

Bountiful, United States, 84010

Status
Completed
 
Locations

Family Plaza Pharmacy

West Jordan, United States, 84088

Status
Completed
 
Locations

Rxtra Care U & I

Bellevue, United States, 98007

Status
Completed
 
Locations

Kelley-Ross Pharmacy

Seattle, United States, 98122

Status
Completed
 

Trial Design