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Efficacy and Safety of the Mometasone Nasal Gel in the Treatment of Persistent Allergic Rhinitis
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 Adults
1 other identifier
interventional
N/A
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
Started May 2019
Shorter than P25 for phase_3
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 1, 2016
CompletedFirst Posted
Study publicly available on registry
November 2, 2016
CompletedStudy Start
First participant enrolled
May 1, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2020
CompletedNovember 4, 2020
November 1, 2020
7 months
November 1, 2016
November 3, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Efficacy of allergic rhinitis treatment based proportion of participants who show at least moderate relief
14 days
Secondary Outcomes (1)
Safety will be evaluated by the adverse events occurrences
14 days
Study Arms (2)
EMS Mometasone gel
EXPERIMENTALThe patient should administer 2 spray in each nostril, once daily.
Mometasone spray nasal
ACTIVE COMPARATORThe patient should administer 2 spray in each nostril, once daily.
Interventions
The patient should administer 2 spray in each nostril, once daily.
The patient should administer 2 spray in each nostril, once daily.
Eligibility Criteria
You may qualify if:
- Signed Consent of the patient;
- Clinical diagnosis of moderate - severe persistent allergic rhinitis according to ARIA classification(Allergic Rhinitis and Its Impact on Asthma);
You may not qualify if:
- 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);
- History of hypertension, coronary artery disease, cardiac arrhythmias, glaucoma, hyperthyroidism and / or prostatic hypertrophy.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EMSlead
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 1, 2016
First Posted
November 2, 2016
Study Start
May 1, 2019
Primary Completion
December 1, 2019
Study Completion
March 1, 2020
Last Updated
November 4, 2020
Record last verified: 2020-11