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Mometasone Furoate Aqueous (MK-0887/SCH 032088) Nasal Spray vs Placebo and FLONASE® in Seasonal Allergic Rhinitis Patients (I94-001) | Clinical Trials | Clareo Health

COMPLETEDPHASE3

Mometasone Furoate Aqueous (MK-0887/SCH 032088) Nasal Spray vs Placebo and FLONASE® in Seasonal Allergic Rhinitis Patients (I94-001)

Efficacy and Safety of Mometasone Furoate Aqueous Nasal Spray vs Placebo and Flonase® (Fluticasone Propionate) in Seasonal Allergic Rhinitis Patients (I94-001)

NCT03882047•Organon and Co

View on ClinicalTrials.gov

Summary

The purpose of this study is to evaluate the efficacy and safety of mometasone furoate (SCH 32088) aqueous nasal spray 200 mcg once daily compared to placebo once daily in the treatment of participants with seasonal allergic rhinitis. Flonase (fluticasone propionate) nasal spray 200 mcg once daily has been chosen as the active control for this study.

Eligibility

Age

12 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•2-year history of seasonal allergic rhinitis
•Positive skin test response to a local seasonal allergen (current, or performed in investigator's office within the past year)
•Good health and free of any unstable, clinically significant disease, other than allergic rhinitis, that would interfere with the study schedule or evaluation of seasonal allergic rhinitis

Exclusion Criteria

•Women who are pregnant or breastfeeding
•Women of childbearing potential who are not using an acceptable form of birth control
•Significant history of metabolic, cardiovascular, neurologic, hematologic, hepatic, gastrointestinal, cerebrovascular, respiratory, or renal disease, or any other disorder which, in the judgment of the investigator, could interfere with the study, or require treatment which might interfere with the study
•Use of any chronic medication which could affect the course of seasonal allergic rhinitis
•Asthma requiring chronic use of inhaled or systemic corticosteroids (inhaled bronchodilators are permitted for asthma treatment)
•Current or history of frequent, clinically significant sinusitis or chronic purulent postnasal drip
•Upper respiratory tract or sinus infection that requires antibiotic therapy within the previous 2 weeks, or a viral upper respiratory infection (URI) within the 7 days prior to Screening
•Dependence upon nasal, oral or ocular decongestants, or nasal topical antihistamines, in the opinion of the investigator
•Has rhinitis medicamentosa
•Investigational drug use within the previous 30 days
+4 more criteria

Key Dates

Start Date

August 11, 1994

Primary Completion Date

September 16, 1994

Completion Date

September 16, 1994

Last Updated

February 9, 2022

Enrollment

313

ACTUAL participants

Conditions

Rhinitis, Allergic, Seasonal

Interventions

Mometasone furoate

DRUG

Fluticasone propionate

DRUG

Mometasone furoate placebo

DRUG

Fluticasone propionate 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.

View ClinicalTrials.gov Terms and Conditions

Mometasone Furoate Aqueous (MK-0887/SCH 032088) Nasal Spray vs Placebo and FLONASE® in Seasonal Allergic Rhinitis Patients (I94-001)

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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