check_circleStudy Completed

Pain

Bayer Identifier:

15647

ClinicalTrials.gov Identifier:

NCT01427803

EudraCT Number:

Not Available

EU CT Number:

Not Available
Actual Use Trial of Naproxen Sodium

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.

Key Participants Requirements

Sex

Both

Age

12 - N/A
  • - 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
  • - 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
778
Trial Dates
September 2011 - December 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
Countryside PharmacySavannah, 64485, United States
Completed
Northfield PharmacyNorthfield, 55057-2434, United States
Completed
Ostrom DrugsKenmore, 98028, United States
Completed
The Medicine ShoppeBountiful, 84010, United States
Completed
Goodrich PharmacyFridley, 55432, United States
Completed
Pinson Discount DrugsPinson, 35126, United States
Completed
The Medicine ShoppeOgden, 84401, United States
Completed
Duran Central PharmacyAlbuquerque, 87104, United States
Terminated
Hurricane Family PharmacyHurricane, 84737, United States
Completed
Kussler's PharmacySnohomish, 98290, United States
Completed
Setzer PharmacyRoseville, 55113, United States
Completed
Family Plaza PharmacyWest Jordan, 84088, United States
Completed
Stevenson Family PharmacySt. Joseph, 64504, United States
Completed
Community Clinical PharmacyMesa, 85202, United States
Completed
Albers Medical PharmacyKansas City, 64111, United States
Completed
Catonsville PharmacyBaltimore, 21228, United States
Completed
Northview PharmacyLayton, 84041, United States
Completed
Lafayette PharmacyRichmond, 23221, United States
Completed
Pharmacy at the PigMcCalla, 35111-3406, United States
Completed
Robert's Discount PharmacyHoover, 35226, United States
Completed
Taos PharmacyTaos, 87571, United States
Completed
B & B PharmacyYorba Linda, 92886, United States
Completed
The Medicine CenterSalt Lake City, 84121, United States
Completed
The Apothecary ShoppeSalt Lake City, 84102, United States
Terminated
Rxtra Care U & IBellevue, 98007, United States
Completed
Island View PharmacySyracuse, 84075, United States
Completed
Pharmacy PlusAlbuquerque, 87107, United States
Completed
Stark PharmacyOverland Park, 66209, United States
Completed
Goodrich PharmacyAndover, 55304, United States
Completed
Kemper DrugElk River, 55330, United States
Completed
Coast Compounding PharmacyOceanside, 92054, United States
Completed
Montpelier PharmacyMontpelier, 23192, United States
Completed
Cub PharmacyRosemount, 55068, United States
Completed
Medical Arts Rexall PharmacyAnaheim, 92801, United States

Primary Outcome

  • Estimated Percentage of Misuse for Non-Therapeutic Reasons
    date_rangeTime Frame:
    28 days
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Non-therapeutic Reasons for Misuse
    date_rangeTime Frame:
    28 days
    enhanced_encryption
    Safety Issue:
    No
  • Estimated Percentage of Misuse for Non-Therapeutic Reasons Using the First 10-Day Treatment Course
    date_rangeTime Frame:
    28 days
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants took >/= 2 tablets/use day in any 10 use days
    date_rangeTime Frame:
    28 days
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants who took product with mean daily use >/= 2 tablets /use day
    date_rangeTime Frame:
    28 days
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants with at least one dosing occasion where more than one tablet was taken
    date_rangeTime Frame:
    28 days
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of dosing occasions where more than one tablet was taken
    date_rangeTime Frame:
    28 days
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of participants where a dose was taken less than 22 hours after the most recent previous dose
    date_rangeTime Frame:
    28 days
    enhanced_encryption
    Safety Issue:
    No
  • Percentage of dosing occasions where a dose was taken less than 22 hours after the most recent previous dose
    date_rangeTime Frame:
    28 days
    enhanced_encryption
    Safety Issue:
    No

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

Additional Information

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