Trial Condition(s):
Pain
Self Selection Trial of Naproxen Sodium (KEIFER SST)
Bayer Identifier:
15833
ClinicalTrials.gov Identifier:
EudraCT Number:
EU CT Number:
Not Available
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 informationExclusion 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
Trial Dates
Phase
Could I receive a placebo?
Products
Accepts Healthy Volunteers
Where to Participate
| Locations | |
|---|---|
Locations B & B Pharmacy Yorba Linda, United States, 92886 | 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 Pill Box Pharmacy Pembroke Pines, United States, 33026 | Contact Us: E-mail: [email protected] Phone: Not Available |
Locations Wynn's Pharmacy Griffin, United States, 30224 | 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 Goodrich Pharmacy Andover, United States, 55304 | 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 Family Plaza Pharmacy West Jordan, United States, 84088 | 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 Kelley-Ross Pharmacy Seattle, United States, 98122 | Contact Us: E-mail: [email protected] Phone: Not Available |
Trial Design
A Pilot Self Selection Trial of an Extended-Release Over-the-Counter Analgesic
Trial Type:
Interventional
Intervention Type:
Drug
Trial Purpose:
Other
Allocation:
Non-randomized
Blinding:
Open Label
Assignment:
Parallel Assignment
Trial Arms:
1
Primary Outcome
- The percentage of participants who selected Naproxen Sodium ER and expected their pain to last more than 12 hoursTimeframe: Up to 14 days
Secondary Outcome
- The percentage of participants who selected Naproxen Sodium ER , expected their pain to last more than 12 hours and reported their selection decision within first 24 hoursTimeframe: Within 24 hours of their selection decision taken up to 14 days
- The percentage of low literacy participants who selected Naproxen Sodium ER and expected their pain to last more than 12 hoursTimeframe: Up to 14 days
Additional Information
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