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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: NCT02953379
Recruitment Status : Withdrawn (Sponsor decision)
First Posted : November 2, 2016
Last Update Posted : November 4, 2020
Sponsor:
Information provided by (Responsible Party):
EMS

Tracking Information
First Submitted Date  ICMJE November 1, 2016
First Posted Date  ICMJE November 2, 2016
Last Update Posted Date November 4, 2020
Estimated Study Start Date  ICMJE May 2019
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 1, 2016)
Efficacy of allergic rhinitis treatment based proportion of participants who show at least moderate relief [ Time Frame: 14 days ]
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: November 1, 2016)
Safety will be evaluated by the adverse events occurrences [ Time Frame: 14 days ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy and Safety of the Mometasone Nasal Gel in the Treatment of Persistent Allergic Rhinitis
Official Title  ICMJE 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
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Investigator)
Primary Purpose: Treatment
Condition  ICMJE Allergic Rhinitis
Intervention  ICMJE
  • Drug: EMS Mometasone gel
    The patient should administer 2 spray in each nostril, once daily.
  • Drug: Mometasone spray nasal
    The patient should administer 2 spray in each nostril, once daily.
    Other Name: Nasonex
Study Arms  ICMJE
  • Experimental: EMS Mometasone gel
    The patient should administer 2 spray in each nostril, once daily.
    Intervention: Drug: EMS Mometasone gel
  • Active Comparator: Mometasone spray nasal
    The patient should administer 2 spray in each nostril, once daily.
    Intervention: Drug: Mometasone spray nasal
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Withdrawn
Actual Enrollment  ICMJE
 (submitted: November 3, 2020)
0
Original Estimated Enrollment  ICMJE
 (submitted: November 1, 2016)
278
Estimated Study Completion Date  ICMJE March 2020
Estimated Primary Completion Date December 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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);
  • History of hypertension, coronary artery disease, cardiac arrhythmias, glaucoma, hyperthyroidism and / or prostatic hypertrophy.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 65 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02953379
Other Study ID Numbers  ICMJE EMS1315
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party EMS
Study Sponsor  ICMJE EMS
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account EMS
Verification Date November 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP