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Pseudoephedrine

Phase 3

Common Cold | Small molecule | Infectious Disease |Bayer AG|Last Updated: Sep 1, 2017

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment1,016

FDA Designations

No designations recorded

Clinical trial landscape

Pseudoephedrine · 1 trial · 2 indications

Phase 3 1
NCT01062360Placebo and Active Controlled Study to Assess Efficacy and Tolerability of Aspirin Plus PseudoephedrineCommon Cold
COMPLETED1,016 Analytics
PHASE3COMPLETED
Placebo and Active Controlled Study to Assess Efficacy and Tolerability of Aspirin Plus Pseudoephedrine
Common ColdUnlock trial analytics

Study Endpoints

Primary Endpoints

The primary efficacy parameter for the nasal congestion was the AUC calculated for baseline adjusted NCS for the initial 2 hours post dosing
2 hours
The primary efficacy parameter for sore throat was SPID2 hours
2 hours

Secondary Endpoints

The Pain Intensity Difference at time point: 15, 30, 60, 90, 120, 240, and 360 minutes after the first dose
15, 30, 60, 90, 120, 240, and 360 minutes
The Nasal Congestion Score
15, 30, 60, 90, 120, 240, and 360 minutes
The Nasal Congestion Relief Score
15, 30, 60, 90, 120, 240, and 360 minutes
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Study Design & Arms

AllocationRANDOMIZED
MaskingQUADRUPLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2ACTIVE_COMPARATOR -
Arm 3ACTIVE_COMPARATOR -
Arm 4PLACEBO_COMPARATOR -

Interventions

NameTypeDescription
Acetylsalicylic Acid (Aspirin Complex, BAYE4465) + PseudoephedrineDRUGSingle oral dose of 1 to 2 Aspirin Complex sachets, each containing granules of 500 mg Acetylsalicylic Acid (ASA) and 30 mg Pseudoephedrine (PSE), to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
Acetylsalicylic Acid (Aspirin, BAYE4465)DRUGSingle oral dose of 1 to 2 sachets Acetylsalicylic Acid, each containing granules of 500 mg Acetylsalicylic Acid (ASA), to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
PseudoephedrineDRUGSingle oral dose of 1 to 2 sachets Pseudoephedrine, each containing granules 30 mg Pseudoephedrine, to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
PlaceboDRUGSingle oral dose of 1 to 2 sachets, each containing Placebo granules, to be taken orally after dissolving in a glass of water; to be repeated as needed every 6 hours for a period of not more than 3 days.
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites59

Inclusion Criteria:- Male and female subjects between 18 and 65 years of age.- Onset of cold symptoms within 96 hours (4 days) before study participation.- Current complaint of at least moderate sore throat at baseline- Current complaint of at least moderate NC at baseline- History of other symptoms...

Countries:United StatesItalyPolandSlovakia
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Frequently asked questions about Pseudoephedrine

What is Pseudoephedrine used for?

Pseudoephedrine is a small molecule drug being developed by Bayer AG for the treatment of the common cold. It is currently in Phase 3 clinical development, meaning it is investigational and not yet approved. The drug is being studied for its efficacy and tolerability in patients with common cold and pharyngitis.

What does Pseudoephedrine target?

Pseudoephedrine is a decongestant that works by narrowing the blood vessels in the nasal passages, reducing swelling and congestion. It is being studied in combination with aspirin for the treatment of common cold symptoms. The drug is in Phase 3 clinical trials to assess its efficacy and tolerability.

Who makes Pseudoephedrine?

Pseudoephedrine is being developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is listed on the stock exchange under the ticker BAYRY. The drug is currently in Phase 3 clinical development for the treatment of the common cold and pharyngitis.

What phase is Pseudoephedrine in?

Pseudoephedrine is in Phase 3 clinical development. It is an investigational drug and has not yet been approved by regulatory authorities. The Phase 3 trial, NCT01062360, has been completed and enrolled 1,016 participants to evaluate the efficacy and tolerability of aspirin plus pseudoephedrine for common cold and pharyngitis.

What clinical trials is Pseudoephedrine in?

Pseudoephedrine has one completed Phase 3 clinical trial, NCT01062360, titled 'Placebo and Active Controlled Study to Assess Efficacy and Tolerability of Aspirin Plus Pseudoephedrine.' This randomized, double-blind, placebo-controlled trial enrolled 1,016 participants with common cold and pharyngitis across the United States, Italy, Poland, and Slovakia.

Is Pseudoephedrine the same as other decongestants?

Pseudoephedrine is a specific decongestant drug being studied by Bayer AG for the common cold. It is being evaluated in combination with aspirin in a Phase 3 clinical trial. The drug is not approved and remains in clinical development, with its safety and efficacy still being assessed.