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The Effects of Phenylephrine Compared With Those of Placebo and Pseudoephedrine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis (SAR)(P04579) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

The Effects of Phenylephrine Compared With Those of Placebo and Pseudoephedrine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis (SAR)(P04579)

Crossover Study of the Decongestant Effect of Phenylephrine Compared With Placebo and Pseudoephedrine as Active Control in SAR Subjects Exposed to Pollen in the Vienna Challenge Chamber

NCT00276016•Organon and Co

View on ClinicalTrials.gov

Summary

This is a Phase 3, single-dose, investigator-blind, randomized, placebo-controlled, crossover study, conducted at a single site in Austria, outside of the normal grass pollen season. An allergic reaction will be induced by exposing subjects to grass pollen in the Vienna Challenge Chamber (VCC). Subjects will receive a single dose of each of the following treatments according to a randomization sequence: Phenylephrine 12 mg immediate-release capsule, pseudoephedrine 60 mg immediate-release tablet, and placebo capsule. There will be a minimum of a 5-day washout period between each treatment. Subjects will complete symptom evaluations throughout the study. The nasal decongestant effects of phenylephrine will be compared to those of placebo using the subjective symptom evaluations. The safety profile (adverse events and vital signs) of the treatments will also be evaluated.

Eligibility

Age

18 - 55 years

Sex

ALL

Healthy Volunteers

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 evaluation time point during each of the 120-minute screening period challenge sessions:
•1. Nasal Congestion Score of at least 2 (moderate);
•2. Total Nasal Symptoms Score of at least 6;
•3. Total Non-nasal Symptoms Score of at least 2.
•Freedom from any clinically significant disease, other than SAR, that would interfere with the study evaluations.

Exclusion Criteria

•An upper or lower respiratory tract infection within 4 weeks before Screening.
•Dependence upon nasal, oral, or ocular decongestants, nasal topical antihistamines, or nasal steroids, in the opinion of the investigator.
•A known potential for hypersensitivity, allergy, or idiosyncratic reaction to the study drug or excipients.

Key Dates

Start Date

January 1, 2006

Primary Completion Date

February 1, 2006

Completion Date

February 1, 2006

Last Updated

February 9, 2022

Enrollment

ACTUAL participants

Conditions

Rhinitis, Allergic, Seasonal

Interventions

phenylephrine

DRUG

pseudoephedrine

DRUG

placebo

DRUG

An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)

NCT00127647

Rhinitis, Allergic, Seasonal

View study

COMPLETEDPHASE3

Study for the Treatment of Intermittent Allergic Rhinitis With Desloratadine (Study P04683)

NCT00406783

Rhinitis, Allergic, SeasonalRhinitis, Allergic, Perennial

View study

COMPLETED

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: February 9, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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The Effects of Phenylephrine Compared With Those of Placebo and Pseudoephedrine on Nasal Congestion in Subjects With Seasonal Allergic Rhinitis (SAR)(P04579)

Inclusion Criteria

Exclusion Criteria

An Approved Drug to Study a New Indication for Allergic Rhinitis (0476-327)

Study for the Treatment of Intermittent Allergic Rhinitis With Desloratadine (Study P04683)

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