Nasonex® Nasal Suspension 50 μg Long-term Designated Drug... | NCT00903721

Studies
Nasonex® Nasal Suspension 50 μg Long-term Designated Drug Use Investigation (Study P05876)

NCT00903721

Sponsor

Organon and Co

Status

Completed

Last Update Posted

Feb 16, 2022Actual

Enrollment

3,806Actual

Phase

Not provided

Conditions

Allergic Rhinitis

Interventions

mometasone furoate

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

Feb 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Nov 2008

Primary Completion Date

Oct 2012Actual

Completion Date

Oct 2012Actual

First Submitted Date

May 14, 2009

First Submission Date that Met QC Criteria

May 14, 2009

First Posted Date

May 18, 2009Estimated

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

Feb 7, 2022

Last Update Posted Date

Feb 16, 2022Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

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 investigation will be conducted to define safety and efficacy under the conditions of post-marketing use of this drug in subjects with allergic rhinitis.

Post-marketing surveys are not considered applicable clinical trials and thus the results of this survey will not be posted at its conclusion. The results will be submitted to public health officials as required by applicable national and international laws.

Detailed Description

Not provided

Design Module

Study Type

Observational

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

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,806Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1		Patients with perennial allergic rhinitis	Drug: mometasone furoate
2		Patients with seasonal allergic rhinitis (including patients who also have perennial allergic rhinitis)	Drug: mometasone furoate

Interventions

Name	Type	Description	Arm Group Labels	Other Names
mometasone furoate	Drug	Metered-dose spray type suspension containing 50 μg mometasone furoate per spray. 2 sprays per nostril twice daily (total daily dose 200 μg) Duration: up to 6 months

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Estimate the incidence of Adverse Drug Reactions (ADRs)		After 6 months of observation

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who are treated with Nasonex for perennial or seasonal allergic rhinitis.

Exclusion Criteria:

Patients with an infection for which there is no effective antimicrobial drug or systemic fungal infection [symptoms may exacerbate]
Patients with a history of hypersensitivity to any ingredient of this drug

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Japanese patients with perennial allergic rhinitis and/or seasonal allergic rhinitis

Sampling Method

Non-Probability Sample

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