Back to resultsEfficacy and Safety of the Mometasone Nasal Gel in the Treatment of Persistent Allergic Rhinitis
Primary Purpose
Allergic Rhinitis
Status
Withdrawn
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
EMS Mometasone gel
Mometasone spray nasal
Sponsored by
About this trial
This is an interventional treatment trial for Allergic Rhinitis
Eligibility Criteria
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).
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
EMS Mometasone gel
Mometasone spray nasal
Arm Description
The patient should administer 1 spray in each nostril once daily.
The patient should administer 1 spray in each nostril once daily.
Outcomes
Primary Outcome Measures
Efficacy of allergic rhinitis treatment based proportion of participants who show at least moderate relief.
Secondary Outcome Measures
Safety will be evaluated by the adverse events occurrences
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT02953366
Brief Title
Efficacy and Safety of the Mometasone Nasal Gel in the Treatment of Persistent Allergic Rhinitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Withdrawn
Why Stopped
Sponsor decision
Study Start Date
May 2019 (Anticipated)
Primary Completion Date
December 2019 (Anticipated)
Study Completion Date
May 2020 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
EMS
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Allergic Rhinitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
EMS Mometasone gel
Arm Type
Experimental
Arm Description
The patient should administer 1 spray in each nostril once daily.
Arm Title
Mometasone spray nasal
Arm Type
Active Comparator
Arm Description
The patient should administer 1 spray in each nostril once daily.
Intervention Type
Drug
Intervention Name(s)
EMS Mometasone gel
Intervention Description
The patient should administer 1 spray in each nostril once daily.
Intervention Type
Drug
Intervention Name(s)
Mometasone spray nasal
Other Intervention Name(s)
Nasonex
Intervention Description
The patient should administer 1 spray in each nostril once daily.
Primary Outcome Measure Information:
Title
Efficacy of allergic rhinitis treatment based proportion of participants who show at least moderate relief.
Time Frame
28 days
Secondary Outcome Measure Information:
Title
Safety will be evaluated by the adverse events occurrences
Time Frame
28 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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).
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of the Mometasone Nasal Gel in the Treatment of Persistent Allergic Rhinitis
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