Efficacy and Safety of the Mometasone Nasal Gel in the Tr... | NCT02953366

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

NCT02953366

Sponsor

EMS

Status

Withdrawn

Last Update Posted

Nov 4, 2020Actual

Enrollment

0Actual

Phase

Phase 3

Conditions

Allergic Rhinitis

Interventions

EMS Mometasone gel
Mometasone spray nasal

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2020

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Sponsor decision

Expanded Access Info

Start Date

May 2019Estimated

Primary Completion Date

Dec 2019Estimated

Completion Date

May 2020Estimated

First Submitted Date

Nov 1, 2016

First Submission Date that Met QC Criteria

Nov 1, 2016

First Posted Date

Nov 2, 2016Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Nov 3, 2020

Last Update Posted Date

Nov 4, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
EMS Mometasone gel	Experimental	The patient should administer 1 spray in each nostril once daily.	Drug: EMS Mometasone gel
Mometasone spray nasal	Active Comparator	The patient should administer 1 spray in each nostril once daily.	Drug: Mometasone spray nasal

Interventions

Name	Type	Description	Arm Group Labels	Other Names
EMS Mometasone gel	Drug	The patient should administer 1 spray in each nostril once daily.	EMS Mometasone gel

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy of allergic rhinitis treatment based proportion of participants who show at least moderate relief.		28 days

Secondary Outcomes

Measure	Description	Time Frame
Safety will be evaluated by the adverse events occurrences		28 days

Other Outcomes

Not provided

Eligibility Module

Eligibility 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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Years

Maximum Age

11 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D065631	Rhinitis, Allergic

Ancestor Terms

ID	Term
D012220	Rhinitis
D009668	Nose Diseases
D012140	Respiratory Tract Diseases
D012130	Respiratory Hypersensitivity

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000068656	Mometasone Furoate

Ancestor Terms

ID	Term
D011244	Pregnadienediols
D011245	Pregnadienes
D011278	Pregnanes
D013256	Steroids
D000072473

Browse Leaves

Not provided

Browse Branches

Not provided