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Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old (P04292)

Primary Purpose

Nasal Polyps

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

Mometasone Furoate Nasal Spray (MFNS)

Placebo nasal spray

About this trial

This is an interventional treatment trial for Nasal Polyps

Eligibility Criteria

6 Years - 17 Years (Child)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

A subject must be 6 to <18 years of age, of either sex, and of any race.
A subject must have a diagnosis of bilateral nasal polyps.
A subject must have a minimum nasal congestion/obstruction
An asthmatic subject may be included.
A subject's clinical laboratory tests (hematology, blood chemistry, and urinalysis) must be within normal limits or clinically acceptable to the investigator/sponsor.
The subject and parent/guardian must be willing to give written informed consent, and the subject must be able to adhere to dose and visit schedules.
A female subject of child-bearing potential who is sexually active must have been using a medically accepted method of contraception prior to Screening and must continue using it while receiving protocol-specified medication. If a pre-menarche female subject begins menstruating during the study, a serum pregnancy test must be done at the next visit

Exclusion Criteria:

A subject with antrochoanal polyps.
A subject with cystic fibrosis.
A subject with acute sinusitis, concurrent upper respiratory tract infection, or who had an upper respiratory tract infection within 2 weeks prior to the Screening Visit.
A subject with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study.
A subject who is immunocompromised.
A subject with ongoing rhinitis medicamentosa.
A subject with Churg Strauss syndrome.
A subject with dyskinetic ciliary syndromes, eg, Young's syndrome (sinopulmonary infections and obstructive azoospermia) or Kartagener's syndrome (immotile cilia).
A subject with any clinically significant pretreatment laboratory, vital sign, or ECG abnormality.
A subject with allergy/sensitivity to aspirin, corticosteroids, or study drug or its excipients.
A subject who has not observed the medication washout times outlined in the protocol prior to the Screening Visit.
A female subject who is breast-feeding, pregnant, or intends to become pregnant.
A subject who has used any investigational drug within 30 days of Screening.
A subject who is part of the staff personnel directly involved with this study.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Experimental

Placebo Comparator

Arm Label

MFNS 100 mcg QD for subjects 6 to less than 12 years

Placebo QD for subjects 6 to less than 12 years

MFNS 200 mcg QD for subjects 12 to less than 18 years

MFNS 200 mcg BID for subjects 12 to less than 18 years

Placebo QD for subjects 12 to less than 18 years

MFNS 100 mcg BID for subjects 6 to less than 12 years

Placebo BID for subjects 6 to less than 12 years

Placebo BID for subjects 12 to less than 18 years

Arm Description

Mometasone Furoate nasal Spray (MFNS) 100 mcg once per day (QD) for subjects 6 to less than 12 years of age

Outcomes

Primary Outcome Measures

Change From Baseline 24-hour Urinary Free Cortisol Level

The primary objective of this study was to evaluate the safety of Mometasone Furoate Nasal Spray (MFNS) in the treatment of pediatric subjects 6 to <18 years of age. Primary safety was to be assessed by determining the subject's 24-hour urinary free cortisol level.

Secondary Outcome Measures

Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine

The key secondary objective of this study was the assessment of the 24-hour urinary free cortisol level (corrected for creatinine).

Full Information

NCT ID

NCT00378378

First Posted

September 18, 2006

Last Updated

February 7, 2022

Sponsor

Organon and Co

1. Study Identification

Unique Protocol Identification Number

NCT00378378

Brief Title

Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old (P04292)

Official Title

Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old

Study Type

Interventional

2. Study Status

Record Verification Date

February 2022

Overall Recruitment Status

Completed

Study Start Date

July 2006 (undefined)

Primary Completion Date

June 2008 (Actual)

Study Completion Date

June 2008 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Organon and Co

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

The purpose of this study is to evaluate the safety and efficacy of Nasonex® (Mometasone Furoate Nasal Spray(MFNS)) in the treatment of nasal polyps in pediatric subjects between the ages of 6 and less than 18 years old. Safety will be the primary focus of this study.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Nasal Polyps

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

127 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MFNS 100 mcg QD for subjects 6 to less than 12 years

Arm Type

Experimental

Arm Description

Mometasone Furoate nasal Spray (MFNS) 100 mcg once per day (QD) for subjects 6 to less than 12 years of age

Arm Title

Placebo QD for subjects 6 to less than 12 years

Arm Type

Placebo Comparator

Arm Title

MFNS 200 mcg QD for subjects 12 to less than 18 years

Arm Type

Experimental

Arm Title

MFNS 200 mcg BID for subjects 12 to less than 18 years

Arm Type

Experimental

Arm Title

Placebo QD for subjects 12 to less than 18 years

Arm Type

Placebo Comparator

Arm Title

MFNS 100 mcg BID for subjects 6 to less than 12 years

Arm Type

Experimental

Arm Title

Placebo BID for subjects 6 to less than 12 years

Arm Type

Placebo Comparator

Arm Title

Placebo BID for subjects 12 to less than 18 years

Arm Type

Placebo Comparator

Intervention Type

Drug

Intervention Name(s)

Mometasone Furoate Nasal Spray (MFNS)

Other Intervention Name(s)

Nasonex

Intervention Description

100 mcg nasal spray

Intervention Type

Drug

Intervention Name(s)

Placebo nasal spray

Intervention Description

One spray of placebo nasal spray in each nostril once daily for 4 months.

Primary Outcome Measure Information:

Title

Change From Baseline 24-hour Urinary Free Cortisol Level

Description

Time Frame

Baseline to Endpoint

Secondary Outcome Measure Information:

Title

Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine

Description

The key secondary objective of this study was the assessment of the 24-hour urinary free cortisol level (corrected for creatinine).

Time Frame

Baseline to Endpoint

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

17 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: A subject must be 6 to <18 years of age, of either sex, and of any race. A subject must have a diagnosis of bilateral nasal polyps. A subject must have a minimum nasal congestion/obstruction An asthmatic subject may be included. A subject's clinical laboratory tests (hematology, blood chemistry, and urinalysis) must be within normal limits or clinically acceptable to the investigator/sponsor. The subject and parent/guardian must be willing to give written informed consent, and the subject must be able to adhere to dose and visit schedules. A female subject of child-bearing potential who is sexually active must have been using a medically accepted method of contraception prior to Screening and must continue using it while receiving protocol-specified medication. If a pre-menarche female subject begins menstruating during the study, a serum pregnancy test must be done at the next visit Exclusion Criteria: A subject with antrochoanal polyps. A subject with cystic fibrosis. A subject with acute sinusitis, concurrent upper respiratory tract infection, or who had an upper respiratory tract infection within 2 weeks prior to the Screening Visit. A subject with any clinically significant condition or situation, other than the condition being studied that, in the opinion of the investigator, would interfere with the study evaluations or optimal participation in the study. A subject who is immunocompromised. A subject with ongoing rhinitis medicamentosa. A subject with Churg Strauss syndrome. A subject with dyskinetic ciliary syndromes, eg, Young's syndrome (sinopulmonary infections and obstructive azoospermia) or Kartagener's syndrome (immotile cilia). A subject with any clinically significant pretreatment laboratory, vital sign, or ECG abnormality. A subject with allergy/sensitivity to aspirin, corticosteroids, or study drug or its excipients. A subject who has not observed the medication washout times outlined in the protocol prior to the Screening Visit. A female subject who is breast-feeding, pregnant, or intends to become pregnant. A subject who has used any investigational drug within 30 days of Screening. A subject who is part of the staff personnel directly involved with this study.

12. IPD Sharing Statement

Plan to Share IPD

Yes

IPD Sharing Plan Description

http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf http://engagezone.msd.com/ds_documentation.php

Citations:

PubMed Identifier

23331528

Citation

Chur V, Small CB, Stryszak P, Teper A. Safety of mometasone furoate nasal spray in the treatment of nasal polyps in children. Pediatr Allergy Immunol. 2013 Feb;24(1):33-8. doi: 10.1111/pai.12032.

Results Reference

result

Learn more about this trial

Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old (P04292)

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