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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02953366
Recruitment Status : Withdrawn (Sponsor decision)
First Posted : November 2, 2016
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Allergic Rhinitis Drug: EMS Mometasone gel Drug: Mometasone spray nasal Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
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
Estimated Study Start Date : May 2019
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : May 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: EMS Mometasone gel
The patient should administer 1 spray in each nostril once daily.
Drug: EMS Mometasone gel
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.
Drug: Mometasone spray nasal
The patient should administer 1 spray in each nostril once daily.
Other Name: Nasonex




Primary Outcome Measures :
  1. Efficacy of allergic rhinitis treatment based proportion of participants who show at least moderate relief. [ Time Frame: 28 days ]

Secondary Outcome Measures :
  1. Safety will be evaluated by the adverse events occurrences [ Time Frame: 28 days ]


Information from the National Library of Medicine

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Ages Eligible for Study:   6 Years to 11 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
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Responsible Party: EMS
ClinicalTrials.gov Identifier: NCT02953366    
Other Study ID Numbers: EMS1215
First Posted: November 2, 2016    Key Record Dates
Last Update Posted: November 4, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Rhinitis
Rhinitis, Allergic
Respiratory Tract Infections
Infections
Nose Diseases
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Respiratory Hypersensitivity
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases
Mometasone Furoate
Anti-Inflammatory Agents
Dermatologic Agents
Anti-Allergic Agents