- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02953366
Efficacy and Safety of the Mometasone Nasal Gel in the Treatment of Persistent Allergic Rhinitis
November 3, 2020 updated by: EMS
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
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.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 11 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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 Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: EMS Mometasone gel
The patient should administer 1 spray in each nostril once daily.
|
The patient should administer 1 spray in each nostril once daily.
|
Active Comparator: Mometasone spray nasal
The patient should administer 1 spray in each nostril once daily.
|
The patient should administer 1 spray in each nostril once daily.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Efficacy of allergic rhinitis treatment based proportion of participants who show at least moderate relief.
Time Frame: 28 days
|
28 days
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Safety will be evaluated by the adverse events occurrences
Time Frame: 28 days
|
28 days
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
May 1, 2019
Primary Completion (Anticipated)
December 1, 2019
Study Completion (Anticipated)
May 1, 2020
Study Registration Dates
First Submitted
November 1, 2016
First Submitted That Met QC Criteria
November 1, 2016
First Posted (Estimate)
November 2, 2016
Study Record Updates
Last Update Posted (Actual)
November 4, 2020
Last Update Submitted That Met QC Criteria
November 3, 2020
Last Verified
November 1, 2020
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Infections
- Respiratory Tract Infections
- Respiratory Tract Diseases
- Immune System Diseases
- Hypersensitivity, Immediate
- Otorhinolaryngologic Diseases
- Respiratory Hypersensitivity
- Hypersensitivity
- Nose Diseases
- Rhinitis
- Rhinitis, Allergic
- Anti-Inflammatory Agents
- Dermatologic Agents
- Anti-Allergic Agents
- Mometasone Furoate
Other Study ID Numbers
- EMS1215
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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