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Advil

Phase 3

Pain | Small molecule | Pain |Bayer AG|Last Updated: Oct 15, 2015

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLED
Total Trials1
Total Enrollment253

FDA Designations

No designations recorded

Clinical trial landscape

Advil · 1 trial · 1 indication

Phase 3 1
NCT01383486Self Selection Trial of Naproxen SodiumPain
COMPLETED253 Analytics
PHASE3COMPLETED
Self Selection Trial of Naproxen Sodium
PainUnlock trial analytics

Study Endpoints

Primary Endpoints

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

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).

Secondary Endpoints

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
The Percentage of Low Literacy Participants Who Selected Naproxen Sodium ER and Expected Their Pain to Last More Than 12 Hours
Up to 14 days
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL

Treatment Arms

ArmTypeDescription
Naproxen Sodium ER (BAYH6689) or Advil IREXPERIMENTALEligible 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.

Interventions

NameTypeDescription
Naproxen sodium ER (BAYH6689)DRUGNaproxen Sodium ER (BAYH6689): oral tablet upon incidence of pain
AdvilDRUGCommercially available Advil; oral caplet upon incidence of pain
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Eligibility Criteria

Age Range12 Years to N/A
SexALL
Healthy VolunteersYes
Study Sites10

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 guardia...

Countries:United States
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Frequently asked questions about Advil

What is Advil used for?

Advil is used for the treatment of pain. It is a small molecule drug being developed by Bayer AG. The drug is currently in Phase 3 clinical development, and it is intended to provide relief from pain symptoms.

Who makes Advil?

Advil is developed by Bayer AG, a company traded under the ticker symbol BAYRY. The drug is currently in Phase 3 clinical trials for the treatment of pain, and it is a small molecule medication.

What phase is Advil in?

Advil is in Phase 3 clinical development. It is an investigational drug for the treatment of pain, and it has completed one Phase 3 trial. The drug is not yet approved and is still undergoing clinical evaluation.

What clinical trials is Advil in?

Advil has been studied in one clinical trial with the identifier NCT01383486. This trial, titled 'Self Selection Trial of Naproxen Sodium', was a Phase 3 study that has been completed. The trial enrolled 253 participants in the United States and involved healthy volunteers.

Is Advil the same as naproxen sodium?

Advil is the brand name for the drug, and the clinical trial NCT01383486 studied naproxen sodium, which is the active ingredient. The trial was a self-selection study of naproxen sodium, indicating that Advil contains this active ingredient for pain relief.