Self Selection Trial of Naproxen Sodium

Pain Clinical Trial

— KEIFER SST  

Official title:

A Pilot Self Selection Trial of an Extended-Release Over-the-Counter Analgesic

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01383486
• Other study ID #: 15833
• Secondary ID: 2014-005305-20
• Status: Completed
• Phase: Phase 3
• First received: June 27, 2011
• Last updated: September 24, 2015
• Start date: July 2011
• Est. completion date: August 2011

Study information

• Verified date: June 2015
• Source: Bayer
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

A pilot trial to demonstrate that consumers can appropriately select Aleve 24 Hour for their own use based on expected duration of pain greater than 12 hours.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 253
• Est. completion date: August 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 12 Years and older

Eligibility

Inclusion Criteria:

• At least 12 years of age

• Report taking at least one dose of Over-the-counter (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 Nonsteroidal Antiinflammatory Drugs (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.

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label

Related Conditions & MeSH terms

• Pain

Intervention

Drug:
• Naproxen sodium ER (BAYH6689)
Naproxen Sodium ER (BAYH6689): oral tablet upon incidence of pain
• Advil
Commercially available Advil; oral caplet upon incidence of pain

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Bayer

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Percentage of Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours	Participants were instructed to select a product for use upon their pain episode and then call a toll-free number for an interview within 30 minutes of the selection decision. Participants who did not call were interviewed after 14 days for data collection. The primary endpoint was derived from 2 variables: 1) number of participants who selected Naproxen Sodium ER and reported expected duration of pain less than or equal to 12 hrs (A); 2) number of participants who selected Naproxen Sodium ER and report expected duration of pain greater than 12 hrs (B). The results was calculated as B/(A+B).	up to 14 days	No
Secondary	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		Within 24 hours of their selection decision taken up to 14 days	No
Secondary	The Percentage of Low Literacy Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours	In addition to the primary outcome measure evaluated for all selection evaluable participants, this secondary outcome was evaluated separately for low literacy participants. Low Literacy Participants are defined as those who had REALM (Rapid Estimate of Adult Literacy in Medicine) score	Up to 14 days	No

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