Status:
COMPLETED
Actual Use Trial of Naproxen Sodium
Lead Sponsor:
Bayer
Conditions:
Pain
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
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 wh...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
September 1 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2011
Estimated Enrollment :
778 Patients enrolled
Trial Details
Trial ID
NCT01427803
Start Date
September 1 2011
End Date
December 1 2011
Last Update
October 15 2015
Active Locations (34)
Enter a location and click search to find clinical trials sorted by distance.
1
Hoover, Alabama, United States, 35226
2
McCalla, Alabama, United States, 35111-3406
3
Pinson, Alabama, United States, 35126
4
Mesa, Arizona, United States, 85202