Actual Use Trial of Naproxen Sodium (Kiefer AUT)

Bayer

Status and phase

Completed

Phase 3

Conditions

Pain

Treatments

Drug: Naproxen Sodium ER (BAYH6689)

Study type

Interventional

Funder types

Industry

Identifiers

NCT01427803

15647

Details and patient eligibility

About

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 which consumers exceed the label-defined daily dose, thus putting themselves at clinical risk, and 2) the reasons for exceeding the labeled daily dose.

Enrollment

778 patients

Sex

All

Ages

12+ years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

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 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, 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