Trial Condition(s):
Pain
Naproxen Sodium Extended-Release Actual Use Study
Bayer Identifier:
13129
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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
breastfeedingTrial Summary
Enrollment Goal
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Cub Pharmacy St. Louis Park, United States, 55426 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Goodrich Pharmacy Blaine, United States, 55443 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kerr Drug Raleigh, United States, 27606 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Medicine Shoppe Bountiful, United States, 84010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Apothecary Shoppe Salt Lake City, United States, 84102 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Coast Compounding Pharmacy Oceanside, United States, 92054 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kussler's Pharmacy Snohomish, United States, 98290 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Ostrom Drugs Kenmore, United States, 98028 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Manhattan Drug Store Seattle, United States, 98148 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Dryden Drug Company Belton, United States, 64012 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Countryside Pharmacy Savannah, United States, 64485 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Stevenson Family Pharmacy St. Joseph, United States, 64504 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Stark Pharmacy Overland Park, United States, 66209 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Medical Arts Rexall Pharmacy Anaheim, United States, 92801 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Via Verde Pharmacy San Dimas, United States, 91773 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Goodrich Pharmacy St. Francis, United States, 55070 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Goodrich Pharmacy Anoka, United States, 55303 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kemper Drug Elk River, United States, 55330 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kerr Drug Chapel Hill, United States, 27514 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kerr HealthCare Center Raleigh, United States, 27612 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Kroger Pharmacy Cary, United States, 27513 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Medicine Shoppe Ogden, United States, 84401 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Island View Pharmacy Syracuse, United States, 84075 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Family Plaza Pharmacy West Jordan, United States, 84088 | Contact Us: E-mail: [email protected] Phone: Not Available |
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:
1
Primary Outcome
- Use Days With One or More Misuse OccasionsTimeframe: 1 month
Secondary Outcome
- Dosing Occasions With One and More Than One Tablet TakenTimeframe: 1 month
- Use days with and without next dose less than 22 hours laterTimeframe: 1 month
- Number of subjects with and without more than one tablet taken per doseTimeframe: 1 month
- Number of subjects with and without next dose less than 22 hours laterTimeframe: 1 month
- Number of subjects with and without more than 660 mg at least onceTimeframe: 1 month
- Average Daily DoseTimeframe: 1 month
- Number of subjects that have taken study drug on more than 10 consecutive days and not on more than 10 consecutive daysTimeframe: 1 month
- Number of Total Dosing Occasions Per SubjectTimeframe: 1 month
- Number of Dosing Occasions Per Subject That Exceeded 660 mgTimeframe: 1 month
Additional Information
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