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Acetylsalicyclic acid

Phase 3

Drugs, Investigational | Small molecule | Other |Bayer AG|Trials Updated: Dec 19, 2018

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment500

FDA Designations

No designations recorded

Acetylsalicyclic acid clinical trials

Acetylsalicyclic acid · 1 trial · 1 indication

Phase 3 1
NCT01122602Evaluate Analgesic Efficacy of Fast Release AspirinDrugs, Investigational
COMPLETED500 Analytics
PHASE3COMPLETED
Evaluate Analgesic Efficacy of Fast Release Aspirin
Drugs, InvestigationalUnlock trial analytics

Study Endpoints

Primary Endpoints

Time to First Perceptible Pain Relief (PR)
0 to 6 hours
Time to First Perceptible Pain Relief Confirmed
0 to 6 hours

Secondary Endpoints

Time to meaningful pain relief
0 to 6 hours
Pain Intensity at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing
10, 20, 30, 40, and 50 minutes and at 1, 2, 3, 4, 5, and 6 hours post-dose
Pain Intensity Difference (PID) at 10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours After Dosing
10, 20, 30, 40, 50, and 60 minutes and at 2, 3, 4, 5, and 6 hours post-dose
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2ACTIVE_COMPARATOR -
Arm 3PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Acetylsalicyclic acid (Fast acting Aspirin, BAY1019036)DRUGSingle dose of fast acting aspirin 2 x 325 mg = 650 mg total
Acetylsalicyclic acid (Aspirin, BAYE4465)DRUGSingle dose of regular aspirin 2 x 325 mg = 650 mg total
PlaceboDRUGTwo placebo tablets
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Eligibility Criteria

Age Range16 Years to 45 Years
SexALL
Healthy VolunteersYes
Study Sites2

Inclusion Criteria: * Healthy, ambulatory, male and female volunteers between 16 to 45 years of age * Scheduled to undergo surgical removal of either two partial bony impactions or one full bony alone or in combination with a partial bony impaction, soft tissue impaction or erupted third molar. Max...

Countries:United States
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Frequently asked questions about Acetylsalicyclic acid

What is acetylsalicyclic acid?

Acetylsalicyclic acid is a small molecule drug being developed by Bayer AG under the code BAY1019036. It is a fast release aspirin formulation studied as an investigational analgesic. The program has completed a Phase 3 trial evaluating its pain relief effects in 500 participants in the United States.

What is acetylsalicyclic acid used for?

Acetylsalicyclic acid is being studied for analgesic use, meaning pain relief, in an investigational setting. The completed Phase 3 trial evaluated its analgesic efficacy as a fast release aspirin formulation. It is not described as an approved product for these investigational uses in the available program information.

Who makes acetylsalicyclic acid?

Bayer AG develops acetylsalicyclic acid, which carries the company code BAY1019036. Bayer trades on the OTC market under the ticker BAYRY. The fast release aspirin program is listed as a Bayer investigational asset in the analgesic space.

What phase is acetylsalicyclic acid in?

Acetylsalicyclic acid is in Phase 3 development. One Phase 3 trial has been completed, and no trials are currently active. The completed study, NCT01122602, was randomized, double blind, and placebo controlled, enrolling 500 participants in the United States.

What clinical trials is acetylsalicyclic acid in?

Acetylsalicyclic acid has been studied in one completed Phase 3 trial, NCT01122602, titled Evaluate Analgesic Efficacy of Fast Release Aspirin. That randomized, double blind, placebo controlled study enrolled 500 participants in the United States, including healthy volunteers, with a minimum age of 16 years and both sexes eligible.

Is acetylsalicyclic acid the same as fast release aspirin?

Yes. Acetylsalicyclic acid is also known as fast release aspirin and fast acting aspirin, both associated with the code BAY1019036. These names refer to the same Bayer investigational program, so searches for fast release aspirin or fast acting aspirin point to this same asset.