Self Selection Trial of Naproxen Sodium (KEIFER SST)

Bayer

Status and phase: Completed; Phase 3

Conditions: Pain

Treatments: Drug: Naproxen sodium ER (BAYH6689); Drug: Advil

Study type: Interventional

Funder types: Industry

Identifiers

NCT01383486

15833

2014-005305-20 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 253 patients

Sex: All

Ages: 12+ years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

253 participants in 1 patient group

Naproxen Sodium ER (BAYH6689) or Advil IR

Experimental group

Description:

Eligible subjects were provided with 24 Advil immediate-release (IR) caplets containing 200 mg Ibuprofen and Naproxen Sodium extended release (ER) tablets containing 660 mg Naproxen Sodium. Upon a single incidence of pain, subjects were instructed to review both packages and choose one product to use. Subject were not offered any additional instructions for use beyond what is on the packages.

Treatment:

Drug: Advil

Drug: Naproxen sodium ER (BAYH6689)