Self Selection Trial of Naproxen Sodium

• Register: ClinicalTrials.gov
• Last refreshed on: 3 December 2012
• Main ID: NCT01383486
• Date of registration: 27/06/2011
• Primary sponsor: Bayer
• Public title: Self Selection Trial of Naproxen Sodium KEIFER SST
• Scientific title: A Pilot Self Selection Trial of an Extended-Release Over-the-Counter Analgesic
• Date of first enrolment: July 2011
• Target sample size: 253
• Recruitment status: Completed
• URL: http://clinicaltrials.gov/show/NCT01383486
• Study type: Interventional
• Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Countries of recruitment

United States

Contacts

• Name: Bayer Study Director
• Affiliation: Bayer

Key inclusion & exclusion criteria

Inclusion Criteria:

- At least 12 years of age

- Report taking at least one dose of OTC analgesic for pain in the past month

- 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

Exclusion Criteria:

- 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,
acetaminophen, 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 who have a positive urine pregnancy test or who are breastfeeding.



Age minimum: 12 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Pain

Intervention(s)

Drug: Advil

Drug: Naproxen sodium ER (BAYH6689)

Primary Outcome(s)

The Percentage of Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours [Time Frame: up to 14 days]

Secondary Outcome(s)

The Percentage of Low Literacy Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours [Time Frame: Up to 14 days]

The Percentage of Participants Who Selected Naproxen Sodium ER , Expected Their Pain to Last More Than 12 Hours and Reported Their Selection Decision Within First 24 Hours [Time Frame: Within 24 hours of their selection decision taken up to 14 days]

Secondary ID(s)

15833

Source(s) of Monetary Support

Please refer to primary and secondary sponsors