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

Allergic Rhinitis Clinical Trial

Official title:

Phase III, National, Multicenter, Randomized, Single-blind, Non-inferiority to Compare the Efficacy of Mometasone Nasal Gel Compared to Mometasone Nasal Spray in the Treatment of Persistent or Intermittent Allergic Rhinitis in Childrens

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02953366
• Other study ID #: EMS1215
• Status: Withdrawn
• Phase: Phase 3
• Start date: May 2019
• Est. completion date: May 2020

Study information

• Verified date: November 2020
• Source: EMS
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: May 2020
• Est. primary completion date: December 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years to 11 Years

Eligibility

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).

Related Conditions & MeSH terms

• Allergic Rhinitis
• Rhinitis
• Rhinitis, Allergic

Intervention

Drug:
• EMS Mometasone gel
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.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
EMS

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Efficacy of allergic rhinitis treatment based proportion of participants who show at least moderate relief.		28 days
Secondary	Safety will be evaluated by the adverse events occurrences		28 days