check_circleStudy Completed

Pain

Bayer Identifier:

15833

ClinicalTrials.gov Identifier:

NCT01383486

EudraCT Number:

2014-005305-20

EU CT Number:

Not Available
Self Selection Trial of Naproxen Sodium

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.

Key Participants Requirements

Sex

Both

Age

12 - N/A
  • - 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
  • - 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
July 2011 - August 2011
Phase
Phase 3
Could I Receive a placebo
No
Products
Aleve (Naproxen Sodium ER, BAY117031)
Accepts Healthy Volunteer
Yes

Where to participate

StatusInstitutionLocation
Completed
B & B PharmacyYorba Linda, 92886, United States
Completed
Medical Arts Rexall PharmacyAnaheim, 92801, United States
Completed
Pill Box PharmacyPembroke Pines, 33026, United States
Completed
Wynn's PharmacyGriffin, 30224, United States
Completed
Setzer PharmacyRoseville, 55113, United States
Completed
Goodrich PharmacyAndover, 55304, United States
Completed
The Medicine ShoppeBountiful, 84010, United States
Completed
Family Plaza PharmacyWest Jordan, 84088, United States
Completed
Rxtra Care U & IBellevue, 98007, United States
Completed
Kelley-Ross PharmacySeattle, 98122, United States

Primary Outcome

  • The percentage of participants who selected Naproxen Sodium ER and expected their pain to last more than 12 hours
    date_rangeTime Frame:
    Up to 14 days
    enhanced_encryption
    Safety Issue:
    No

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 hours
    date_rangeTime Frame:
    Within 24 hours of their selection decision taken up to 14 days
    enhanced_encryption
    Safety Issue:
    No
  • The percentage of low literacy participants who selected Naproxen Sodium ER and expected their pain to last more than 12 hours
    date_rangeTime Frame:
    Up to 14 days
    enhanced_encryption
    Safety Issue:
    No

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

Additional Information

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