Self Selection Trial of Naproxen Sodium

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

253 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-07-31

Study Completion Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Pain

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Naproxen Sodium ER (BAYH6689) or Advil IR

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.

Group Type EXPERIMENTAL

Naproxen sodium ER (BAYH6689)

Intervention Type DRUG

Naproxen Sodium ER (BAYH6689): oral tablet upon incidence of pain

Advil

Intervention Type DRUG

Commercially available Advil; oral caplet upon incidence of pain

Interventions

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Naproxen sodium ER (BAYH6689)

Naproxen Sodium ER (BAYH6689): oral tablet upon incidence of pain

Intervention Type DRUG

Advil

Commercially available Advil; oral caplet upon incidence of pain

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes