Status:
COMPLETED
Naproxen Sodium Extended-Release Actual Use Study
Lead Sponsor:
Bayer
Collaborating Sponsors:
Pegus Research, Inc.
Conditions:
Pain
Eligibility:
All Genders
12+ years
Phase:
PHASE3
Brief Summary
The purpose of this Study is to assess how subjects will use the investigational product in an uncontrolled, naturalistic environment.
Detailed Description
Issues on adverse event data are addressed in the Adverse Event section. The following acronyms and abbreviations were used in the results section. \- General Educational Development (GED)
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 1 2008
Estimated Enrollment :
497 Patients enrolled
Trial Details
Trial ID
NCT00751400
Start Date
July 1 2008
End Date
November 1 2008
Last Update
August 25 2015
Active Locations (24)
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1
Anaheim, California, United States, 92801
2
Oceanside, California, United States, 92054
3
San Dimas, California, United States, 91773
4
Overland Park, Kansas, United States, 66209