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phenylephrine

Phase 3

Rhinitis, Allergic, Seasonal | Small molecule | Respiratory |Organon & Co.|Last Updated: Feb 9, 2022

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment39

FDA Designations

No designations recorded

Clinical trial landscape

phenylephrine · 1 trial · 1 indication

Phase 3 1
NCT00276016The Effects of Phenylephrine Compared With Those of Placebo and Pseudoephedrine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis (SAR)(P04579)Rhinitis, Allergic, Seasonal
COMPLETED39 Analytics
PHASE3COMPLETED
The Effects of Phenylephrine Compared With Those of Placebo and Pseudoephedrine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis (SAR)(P04579)
Rhinitis, Allergic, Seasonal
NCT0027601639
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Study Endpoints

Primary Endpoints

The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Phenylephrine Compared With Placebo
Baseline to endpoint (6 hour period)

To evaluate the effect of phenylephrine 12-mg immediate-release capsule on nasal congestion in subjects with seasonal allergic rhinitis (SAR) who have been exposed to pollen for 6 hours in the Vienna Challenge Chamber (VCC). The average change from the Baseline was evaluated immediately before treatment start, over the first 6 hour post-dosing. The values for the scale are 0,1,2,3 for measure of symptoms, defined as 0-none, 1-mild, 2-moderate, 3-severe. They are subject-evaluated results.

Secondary Endpoints

The Average Change From Baseline to Endpoint (6 Hours Post-dosing) in Nasal Congestion for Pseudoephedrine and Placebo.
Baseline to endpoint (6 hour period)
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelCROSSOVER
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Phenylephrine, Pseudoephedrine, PlaceboEXPERIMENTALPhenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules.
Pseudoephedrine, Placebo, PhenylephrineEXPERIMENTALPseudoephedrine: 60 mg immediate-release tablets for oral administration. Placebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration.
Placebo, Phenylephrine, PseudoephedrineEXPERIMENTALPlacebo: Placebo capsules. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
Phenylephrine, Placebo, PseudoephedrineEXPERIMENTALPhenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration.
Pseudoephedrine, Phenylephrine, PlaceboEXPERIMENTALPseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration. Placebo: Placebo capsules.
Placebo, Pseudoephedrine, PhenylephrineEXPERIMENTALPlacebo: Placebo capsules. Pseudoephedrine: 60 mg immediate-release tablets for oral administration. Phenylephrine: Immediate-release 12 mg capsules for oral administration.

Interventions

NameTypeDescription
phenylephrineDRUGimmediate-release 12 mg capsules for oral administration
pseudoephedrineDRUG60 mg immediate-release tablets for oral administration
placeboDRUGplacebo capsules
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Eligibility Criteria

Age Range18 Years to 55 Years
SexALL
Healthy VolunteersNo

Inclusion Criteria: * Skin test positive for the grass pollen allergen used in the chamber at Screening or within the prior 12 months. * A negative urine pregnancy test at Screening and at monthly intervals for female subjects of childbearing potential. * The following minimum scores at an evaluati...

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Frequently asked questions about phenylephrine

What is phenylephrine used for in seasonal allergic rhinitis?

Phenylephrine is an investigational small molecule being studied for the treatment of nasal congestion in subjects with seasonal allergic rhinitis (SAR). It is being developed by Organon & Co. (NYSE: OGN) and has completed a Phase 3 clinical trial evaluating its effects compared with placebo and pseudoephedrine.

How does phenylephrine work?

Phenylephrine is a decongestant that works by constricting blood vessels in the nasal passages, which reduces swelling and congestion. It is being studied specifically for its effects on nasal congestion in subjects with seasonal allergic rhinitis, as part of a Phase 3 clinical trial.

Who makes phenylephrine?

Phenylephrine is being developed by Organon & Co., a pharmaceutical company traded on the New York Stock Exchange under the ticker symbol OGN. The company is conducting clinical research to evaluate the drug's safety and efficacy for treating nasal congestion in seasonal allergic rhinitis.

What phase is phenylephrine in?

Phenylephrine is in Phase 3 clinical development for seasonal allergic rhinitis. A Phase 3 trial has been completed, and the drug remains investigational, meaning it has not yet been approved by regulatory authorities. The completed trial enrolled 39 participants.

What clinical trials is phenylephrine in?

Phenylephrine has one completed Phase 3 clinical trial registered as NCT00276016, titled "The Effects of Phenylephrine Compared With Those of Placebo and Pseudoephedrine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis (SAR)(P04579)." The trial enrolled 39 adults and was a controlled, randomized study.

Is phenylephrine the same as pseudoephedrine?

No, phenylephrine is not the same as pseudoephedrine. In the Phase 3 clinical trial NCT00276016, phenylephrine was compared directly with pseudoephedrine and placebo to evaluate its effects on nasal congestion in subjects with seasonal allergic rhinitis, indicating they are distinct treatments being studied.