Trial Condition(s):
Pain
Actual Use Trial of Naproxen Sodium (Kiefer AUT)
Bayer Identifier:
15647
ClinicalTrials.gov Identifier:
EudraCT Number:
Not Available
EU CT Number:
Not Available
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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations Countryside Pharmacy Savannah, United States, 64485 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Northfield Pharmacy Northfield, United States, 55057-2434 | 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 The Medicine Shoppe Bountiful, United States, 84010 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Goodrich Pharmacy Fridley, United States, 55432 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pinson Discount Drugs Pinson, United States, 35126 | 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 Duran Central Pharmacy Albuquerque, United States, 87104 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Hurricane Family Pharmacy Hurricane, United States, 84737 | 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 Setzer Pharmacy Roseville, United States, 55113 | 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 |
Locations Stevenson Family Pharmacy St. Joseph, United States, 64504 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Community Clinical Pharmacy Mesa, United States, 85202 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Albers Medical Pharmacy Kansas City, United States, 64111 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Catonsville Pharmacy Baltimore, United States, 21228 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Northview Pharmacy Layton, United States, 84041 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Lafayette Pharmacy Richmond, United States, 23221 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Pharmacy at the Pig McCalla, United States, 35111-3406 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Robert's Discount Pharmacy Hoover, United States, 35226 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Taos Pharmacy Taos, United States, 87571 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations B & B Pharmacy Yorba Linda, United States, 92886 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations The Medicine Center Salt Lake City, United States, 84121 | 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 Rxtra Care U & I Bellevue, United States, 98007 | 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 Pharmacy Plus Albuquerque, United States, 87107 | 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 Goodrich Pharmacy Andover, United States, 55304 | 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 Coast Compounding Pharmacy Oceanside, United States, 92054 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Montpelier Pharmacy Montpelier, United States, 23192 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Cub Pharmacy Rosemount, United States, 55068 | 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 |
Trial Design
An Actual Use Trial In A Simulated OTC Environment of an Extended-Release Over-the-Counter NSAID
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Treatment
Allocation:
Randomized
Blinding:
Open Label
Assignment:
Single Group Assignment
Trial Arms:
1
Primary Outcome
- Estimated Percentage of Misuse for Non-Therapeutic ReasonsTimeframe: 28 days
Secondary Outcome
- Non-therapeutic Reasons for MisuseTimeframe: 28 days
- Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment CourseTimeframe: 28 days
- Percentage of participants took >/= 2 tablets/use day in any 10 use daysTimeframe: 28 days
- Percentage of participants who took product with mean daily use >/= 2 tablets /use dayTimeframe: 28 days
- Percentage of participants with at least one dosing occasion where more than one tablet was takenTimeframe: 28 days
- Percentage of dosing occasions where more than one tablet was takenTimeframe: 28 days
- Percentage of participants where a dose was taken less than 22 hours after the most recent previous doseTimeframe: 28 days
- Percentage of dosing occasions where a dose was taken less than 22 hours after the most recent previous doseTimeframe: 28 days
Additional Information
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