Efficacy and Safety of the Mometasone Nasal Gel in the Treatment of Persistent Allergic Rhinitis
Phase 3
Withdrawn
- Conditions
- Allergic Rhinitis
- Interventions
- Registration Number
- NCT02953366
- Lead Sponsor
- EMS
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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).
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description EMS Mometasone gel EMS Mometasone gel The patient should administer 1 spray in each nostril once daily. Mometasone spray nasal Mometasone spray nasal The patient should administer 1 spray in each nostril once daily.
- Primary Outcome Measures
Name Time Method Efficacy of allergic rhinitis treatment based proportion of participants who show at least moderate relief. 28 days
- Secondary Outcome Measures
Name Time Method Safety will be evaluated by the adverse events occurrences 28 days