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A Study of Mometasone Furoate Nasal Spray in Perennial Allergic Rhinitis (Study P03748)(COMPLETED) | Clinical Trials | Clareo Health

COMPLETEDPHASE2

A Study of Mometasone Furoate Nasal Spray in Perennial Allergic Rhinitis (Study P03748)(COMPLETED)

Dose Finding and Dose Regimen Study of Mometasone Furoate Nasal Spray in Perennial Allergic Rhinitis

NCT00779545•Organon and Co

View on ClinicalTrials.gov

Summary

This is a multicenter, randomized, double-blind within the dose level, parallel group comparison of mometasone furoate nasal spray in subjects with perennial allergic rhinitis to examine the minimal effective dose, the recommended dose, and the dosing regimen.

Eligibility

Age

16 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Patients of mongoloid race residing in Japan who satisfy all of the following criteria:
•* Patients having symptoms of allergic rhinitis of moderate or severe degree, according to the classification of severity in the guidelines for the treatment of nasal allergy (partial revision) as well as a score of at least 4 in the score of 4 nasal symptoms, at the time of obtaining the informed consent during the pretreatment observation period.
•* Patients in whom the skin or specific IgE test is positive and the cytological examination for eosinophils in nasal discharge or nasal challenge test is positive.
•* Out-patients aged 16 years or over at the time of obtaining the informed consent.
•* Male or female.
•* Patients from whom the informed consent can be obtained in writing (or the informed consent can be obtained from the patient's legally acceptable representative, if under 20 years).
•* Patients who can daily complete the nasal allergy diary.

Exclusion Criteria

•* Patients with a complication of tuberculous disease or lower respiratory tract infection, or patients with a complication of acute upper respiratory tract inflammation or acute laryngopharyngitis which the (sub) investigator considers necessary to treat at the time of enrollment in the treatment.
•* Patients with a complication of infection or systemic mycosis for which no effective antibiotics are available.
•* Patients with unhealed nasal septum ulcer, nasal surgery, or nasal trauma.
•* Patients with hypersensitivity to steroids and mometasone furoate.
•* Patients who are pregnant, nursing, or possibly pregnant, or who desire to become pregnant during the study period.
•* Patients with severe hepatic, renal, or cardiac disorder, blood disease, diabetes, hypertension, or other serious complication, suffering from problems with systemic condition.
•* Patients in whom pollen is an overlapping allergen and the study is planned to be implemented in the pollen release season.
•* Patients with a complication of vasomotor rhinitis or eosinophilic rhinitis.
•* Patients with a complication of nose disease which may interfere with efficacy evaluation of the investigational product.
•* Patients who were complicated by acute upper respiratory tract inflammation during the 7-day observation period prior to enrollment which may affect the nasal symptoms.
+5 more criteria

Key Dates

Start Date

April 8, 2004

Primary Completion Date

August 6, 2004

Completion Date

August 6, 2004

Last Updated

August 15, 2024

Enrollment

455

ACTUAL participants

Conditions

Rhinitis, Allergic, Perennial

Interventions

Placebo

DRUG

Mometasone furoate

DRUG

Mometasone furoate

DRUG

Mometasone furoate

DRUG

Mometasone furoate

DRUG

Mometasone furoate

DRUG

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

NCT00406783

Rhinitis, Allergic, SeasonalRhinitis, Allergic, Perennial

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COMPLETEDPHASE3

Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis

NCT00988247

Rhinitis, Allergic, Perennial

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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: August 15, 2024Data 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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A Study of Mometasone Furoate Nasal Spray in Perennial Allergic Rhinitis (Study P03748)(COMPLETED)

Inclusion Criteria

Exclusion Criteria

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

Long Term Safety and Efficacy Trial of Beclomethasone Dipropionate - Hydrofluoroalkane (BDP-HFA) 320 mcg in Allergic Rhinitis

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