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

EMS

Status and phase

Withdrawn

Phase 3

Conditions

Allergic Rhinitis

Treatments

Drug: Mometasone spray nasal

Drug: EMS Mometasone gel

Study type

Interventional

Funder types

Industry

Identifiers

NCT02953366

EMS1215

Details and patient eligibility

About

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.

Sex

All

Ages

6 to 11 years old

Volunteers

No Healthy Volunteers

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).