Efficacy and Safety of the Mometasone Nasal Gel in the Treatment of Persistent Allergic Rhinitis

NCT ID: NCT02953366

Last Updated: 2020-11-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE3

Study Classification

INTERVENTIONAL

Study Start Date

2019-05-31

Study Completion Date

2020-05-31

Brief Summary

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The purpose of this study is to evaluate the non-inferiority of the clinical efficacy of the mometasone nasal gel in the treatment of allergic rhinitis.

Detailed Description

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Conditions

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Allergic Rhinitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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EMS Mometasone gel

The patient should administer 1 spray in each nostril once daily.

Group Type EXPERIMENTAL

EMS Mometasone gel

Intervention Type DRUG

The patient should administer 1 spray in each nostril once daily.

Mometasone spray nasal

The patient should administer 1 spray in each nostril once daily.

Group Type ACTIVE_COMPARATOR

Mometasone spray nasal

Intervention Type DRUG

The patient should administer 1 spray in each nostril once daily.

Interventions

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EMS Mometasone gel

The patient should administer 1 spray in each nostril once daily.

Intervention Type DRUG

Mometasone spray nasal

The patient should administer 1 spray in each nostril once daily.

Intervention Type DRUG

Other Intervention Names

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Nasonex

Eligibility Criteria

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Inclusion Criteria

* Signed Consent of the patient;
* Clinical diagnosis of moderate - severe persistent allergic rhinitis according to ARIA classification(Allergic Rhinitis and Its Impact on Asthma);

Exclusion Criteria

* Patients with any clinically significant disease that in the investigator is opinion can´t participate in the study;
* Patients with any laboratory finding or image finding that in the investigator is opinion can´t participate in the clinical trial;
* Patients with history of hypersensitivity to any of the formula compounds;
* Participation in clinical trial in the year prior to this study;
* Pregnancy or risk of pregnancy and lactating patients;
* Patients who were in use of drugs that can interfere with evaluation;
* Decongestants dependent patients or patients receiving allergen specific immunotherapy;
* Patients on treatment with monoamine oxidase inhibitors (MAOIs).
Minimum Eligible Age

6 Years

Maximum Eligible Age

11 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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EMS

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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EMS1215

Identifier Type: -

Identifier Source: org_study_id