check_circleStudy Completed

Pain

Bayer Identifier:

13129

ClinicalTrials.gov Identifier:

NCT00751400

EudraCT Number:

2014-005268-13

EU CT Number:

Not Available
Naproxen Sodium Extended-Release Actual Use Study

Trial purpose

The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment.

Key Participants Requirements

Sex

Both

Age

12 Years
  • - 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
  • - 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
    breastfeeding

Trial summary

Enrollment Goal
497
Trial Dates
July 2008 - November 2008
Phase
Phase 3
Could I Receive a placebo
No
Products
Aleve (Naproxen Sodium ER, BAY117031)
Accepts Healthy Volunteer
No

Where to participate

StatusInstitutionLocation
Completed
Cub PharmacySt. Louis Park, 55426, United States
Completed
Goodrich PharmacyBlaine, 55443, United States
Completed
Kerr DrugRaleigh, 27606, United States
Completed
The Medicine ShoppeBountiful, 84010, United States
Completed
The Apothecary ShoppeSalt Lake City, 84102, United States
Completed
Coast Compounding PharmacyOceanside, 92054, United States
Completed
Kussler's PharmacySnohomish, 98290, United States
Completed
Ostrom DrugsKenmore, 98028, United States
Completed
Manhattan Drug StoreSeattle, 98148, United States
Completed
Dryden Drug CompanyBelton, 64012, United States
Completed
Countryside PharmacySavannah, 64485, United States
Completed
Stevenson Family PharmacySt. Joseph, 64504, United States
Completed
Stark PharmacyOverland Park, 66209, United States
Completed
Medical Arts Rexall PharmacyAnaheim, 92801, United States
Completed
Via Verde PharmacySan Dimas, 91773, United States
Completed
Goodrich PharmacySt. Francis, 55070, United States
Completed
Goodrich PharmacyAnoka, 55303, United States
Completed
Kemper DrugElk River, 55330, United States
Completed
Kerr DrugChapel Hill, 27514, United States
Completed
Kerr HealthCare CenterRaleigh, 27612, United States
Completed
Kroger PharmacyCary, 27513, United States
Completed
The Medicine ShoppeOgden, 84401, United States
Completed
Island View PharmacySyracuse, 84075, United States
Completed
Family Plaza PharmacyWest Jordan, 84088, United States

Primary Outcome

  • Use Days With One or More Misuse Occasions
    date_rangeTime Frame:
    1 month
    enhanced_encryption
    Safety Issue:
    No

Secondary Outcome

  • Dosing Occasions With One and More Than One Tablet Taken
    date_rangeTime Frame:
    1 month
    enhanced_encryption
    Safety Issue:
    No
  • Use days with and without next dose less than 22 hours later
    date_rangeTime Frame:
    1 month
    enhanced_encryption
    Safety Issue:
    No
  • Number of subjects with and without more than one tablet taken per dose
    date_rangeTime Frame:
    1 month
    enhanced_encryption
    Safety Issue:
    No
  • Number of subjects with and without next dose less than 22 hours later
    date_rangeTime Frame:
    1 month
    enhanced_encryption
    Safety Issue:
    No
  • Number of subjects with and without more than 660 mg at least once
    date_rangeTime Frame:
    1 month
    enhanced_encryption
    Safety Issue:
    No
  • Average Daily Dose
    date_rangeTime Frame:
    1 month
    enhanced_encryption
    Safety Issue:
    No
  • Number of subjects that have taken study drug on more than 10 consecutive days and not on more than 10 consecutive days
    date_rangeTime Frame:
    1 month
    enhanced_encryption
    Safety Issue:
    No
  • Number of Total Dosing Occasions Per Subject
    date_rangeTime Frame:
    1 month
    enhanced_encryption
    Safety Issue:
    No
  • Number of Dosing Occasions Per Subject That Exceeded 660 mg
    date_rangeTime Frame:
    1 month
    enhanced_encryption
    Safety Issue:
    No

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

Additional Information

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