check_circleStudy Completed
Pain
Bayer Identifier:
13129
ClinicalTrials.gov Identifier:
EudraCT Number:
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
BothAge
12 YearsTrial summary
Enrollment Goal
497Trial Dates
July 2008 - November 2008Phase
Phase 3Could I Receive a placebo
NoProducts
Aleve (Naproxen Sodium ER, BAY117031)Accepts Healthy Volunteer
NoWhere to participate
Status | Institution | Location |
---|---|---|
Completed | Cub Pharmacy | St. Louis Park, 55426, United States |
Completed | Goodrich Pharmacy | Blaine, 55443, United States |
Completed | Kerr Drug | Raleigh, 27606, United States |
Completed | The Medicine Shoppe | Bountiful, 84010, United States |
Completed | The Apothecary Shoppe | Salt Lake City, 84102, United States |
Completed | Coast Compounding Pharmacy | Oceanside, 92054, United States |
Completed | Kussler's Pharmacy | Snohomish, 98290, United States |
Completed | Ostrom Drugs | Kenmore, 98028, United States |
Completed | Manhattan Drug Store | Seattle, 98148, United States |
Completed | Dryden Drug Company | Belton, 64012, United States |
Completed | Countryside Pharmacy | Savannah, 64485, United States |
Completed | Stevenson Family Pharmacy | St. Joseph, 64504, United States |
Completed | Stark Pharmacy | Overland Park, 66209, United States |
Completed | Medical Arts Rexall Pharmacy | Anaheim, 92801, United States |
Completed | Via Verde Pharmacy | San Dimas, 91773, United States |
Completed | Goodrich Pharmacy | St. Francis, 55070, United States |
Completed | Goodrich Pharmacy | Anoka, 55303, United States |
Completed | Kemper Drug | Elk River, 55330, United States |
Completed | Kerr Drug | Chapel Hill, 27514, United States |
Completed | Kerr HealthCare Center | Raleigh, 27612, United States |
Completed | Kroger Pharmacy | Cary, 27513, United States |
Completed | The Medicine Shoppe | Ogden, 84401, United States |
Completed | Island View Pharmacy | Syracuse, 84075, United States |
Completed | Family Plaza Pharmacy | West Jordan, 84088, United States |
Primary Outcome
- Use Days With One or More Misuse Occasionsdate_rangeTime Frame:1 monthenhanced_encryptionNoSafety Issue:
Secondary Outcome
- Dosing Occasions With One and More Than One Tablet Takendate_rangeTime Frame:1 monthenhanced_encryptionNoSafety Issue:
- Use days with and without next dose less than 22 hours laterdate_rangeTime Frame:1 monthenhanced_encryptionNoSafety Issue:
- Number of subjects with and without more than one tablet taken per dosedate_rangeTime Frame:1 monthenhanced_encryptionNoSafety Issue:
- Number of subjects with and without next dose less than 22 hours laterdate_rangeTime Frame:1 monthenhanced_encryptionNoSafety Issue:
- Number of subjects with and without more than 660 mg at least oncedate_rangeTime Frame:1 monthenhanced_encryptionNoSafety Issue:
- Average Daily Dosedate_rangeTime Frame:1 monthenhanced_encryptionNoSafety Issue:
- Number of subjects that have taken study drug on more than 10 consecutive days and not on more than 10 consecutive daysdate_rangeTime Frame:1 monthenhanced_encryptionNoSafety Issue:
- Number of Total Dosing Occasions Per Subjectdate_rangeTime Frame:1 monthenhanced_encryptionNoSafety Issue:
- Number of Dosing Occasions Per Subject That Exceeded 660 mgdate_rangeTime Frame:1 monthenhanced_encryptionNoSafety Issue:
Trial design
Trial Type
InterventionalIntervention Type
DrugTrial Purpose
OtherAllocation
Non-randomizedBlinding
Open LabelAssignment
Single Group AssignmentTrial Arms
1Additional Information
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