Nasal PolypsPhase 3NCT00378378

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

A Phase 3 study testing Mometasone Furoate Nasal Spray (MFNS) in people with Nasal Polyps, run by Organon and Co.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Trial 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. Read more about this study

Who is it for?: Ages 6 to 17 years
Conditions the study is for: Nasal Polyps
What is being tested?: Mometasone Furoate Nasal Spray (MFNS)
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 127 participants
Where: No sites listed yet
Study dates: Jul 2006to Jun 2008
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 6 to 17 years
All sexes
No healthy volunteers
Child

Who may be able to join

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

Who cannot join

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.

Show all 14Show fewer

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.

About this study

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

Conditions: Nasal Polyps
Being tested: Mometasone Furoate Nasal Spray (MFNS), Placebo nasal spray
Medical subject headings: Nasal Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Mometasone Furoate Nasal Spray (MFNS)Drug
Also called Nasonex
100 mcg nasal spray
Placebo nasal sprayDrug
One spray of placebo nasal spray in each nostril once daily for 4 months.

Study groups in NCT00378378
Study group	Role	What they receive
MFNS 100 mcg QD for subjects 6 to less than 12 years	Experimental	Mometasone Furoate nasal Spray (MFNS) 100 mcg once per day (QD) for subjects 6 to less than 12 years of age Receives: Drug: Mometasone Furoate Nasal Spray (MFNS)
Placebo QD for subjects 6 to less than 12 years	Placebo comparator	Not described Receives: Drug: Placebo nasal spray
MFNS 200 mcg QD for subjects 12 to less than 18 years	Experimental	Not described Receives: Drug: Mometasone Furoate Nasal Spray (MFNS)
MFNS 200 mcg BID for subjects 12 to less than 18 years	Experimental	Not described Receives: Drug: Mometasone Furoate Nasal Spray (MFNS)
Placebo QD for subjects 12 to less than 18 years	Placebo comparator	Not described Receives: Drug: Placebo nasal spray
MFNS 100 mcg BID for subjects 6 to less than 12 years	Experimental	Not described Receives: Drug: Mometasone Furoate Nasal Spray (MFNS)
Placebo BID for subjects 6 to less than 12 years	Placebo comparator	Not described Receives: Drug: Placebo nasal spray
Placebo BID for subjects 12 to less than 18 years	Placebo comparator	Not described Receives: Drug: Placebo nasal spray

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: Baseline to Endpoint

Secondary outcomes (1)

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).
Measured: Baseline to Endpoint

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jul 2006Jun 2008

First posted20 Sep 2006 (estimated)
Study startJul 2006
Primary completionJun 2008
Study completionJun 2008

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Nasal PolypsStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 127 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00378378
Sponsor's protocol ID: P04292
Status last verified: Feb 2022
First submitted: 18 Sep 2006
Last updated: 20 May 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Publications

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.
PubMed 23331528

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

Official record

RecruitingPhase 3
A Study to Assess the Efficacy and Safety of GSK5784283 (Felcorekibart) in Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
Nasal Polyps
RecruitingPhase 3
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
RecruitingPhase 4
Biologics in Chronic Rhinosinusitis With Nasal Polyposis
Chronic Sinusitis, Nasal Polyps
Active, not recruitingPhase 3
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Chronic Rhinosinusitis With Nasal Polyps
Active, not recruiting
Comparison of Intraoperative Outcomes of Microdebrider-Assisted Versus Conventional Functional Endoscopic Sinus Surgery in Patients With Sinonasal Polyposis
Nasal Polyps

All Nasal Polyps trials

Study at a glance

From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old
ClinicalTrials.gov ID: NCT00378378
Acronym / sponsor ID: P04292
Conditions: Nasal Polyps
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 127 participants (actual)
Lead sponsor: Organon and CoIndustry (pharma, biotech, devices)
Study start: Jul 2006
Primary completion: Jun 2008 (actual)
Study completion: Jun 2008 (actual)
First posted: 20 Sep 2006 (estimated)
Results: Posted 20 Jul 2010

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 8

Arm	Type	Receives
MFNS 100 mcg QD for subjects 6 to less than 12 years	Experimental	Drug: Mometasone Furoate Nasal Spray (MFNS)Mometasone Furoate nasal Spray (MFNS) 100 mcg once per day (QD) for subjects 6 to less than 12 years of age
Placebo QD for subjects 6 to less than 12 years	Placebo comparator	Drug: Placebo nasal spray
MFNS 200 mcg QD for subjects 12 to less than 18 years	Experimental	Drug: Mometasone Furoate Nasal Spray (MFNS)
MFNS 200 mcg BID for subjects 12 to less than 18 years	Experimental	Drug: Mometasone Furoate Nasal Spray (MFNS)
Placebo QD for subjects 12 to less than 18 years	Placebo comparator	Drug: Placebo nasal spray
MFNS 100 mcg BID for subjects 6 to less than 12 years	Experimental	Drug: Mometasone Furoate Nasal Spray (MFNS)
Placebo BID for subjects 6 to less than 12 years	Placebo comparator	Drug: Placebo nasal spray
Placebo BID for subjects 12 to less than 18 years	Placebo comparator	Drug: Placebo nasal spray

Who may qualify

Ages: 6 to 17 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child

Key inclusion criteria (7 listed)

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.

Key exclusion criteria (14 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Mometasone Furoate Nasal Spray (MFNS)Also: Nasonex100 mcg nasal spray	Drug	MFNS 100 mcg BID for subjects 6 to less than 12 years, MFNS 100 mcg QD for subjects 6 to less than 12 years, MFNS 200 mcg BID for subjects 12 to less than 18 years, MFNS 200 mcg QD for subjects 12 to less than 18 years
Placebo nasal sprayOne spray of placebo nasal spray in each nostril once daily for 4 months.	Drug	Placebo BID for subjects 12 to less than 18 years, Placebo BID for subjects 6 to less than 12 years, Placebo QD for subjects 12 to less than 18 years, Placebo QD for subjects 6 to less than 12 years

Primary outcome

Change From Baseline 24-hour Urinary Free Cortisol Level
Time frame: Baseline to Endpoint
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.

1 secondary outcome

Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine
Time frame: Baseline to Endpoint

Results and safety

Results posted to the registry on 20 Jul 2010, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years	51	51
MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years	50	49
Pooled Placebo	26	24

Primary outcome: Change From Baseline 24-hour Urinary Free Cortisol Level

Time frame: Baseline to Endpoint. Least squares mean (Standard Deviation). Unit: mcg/hour

Measure	MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years n = 44	MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years n = 50	Pooled Placebo n = 25
Baseline	49.5 (32.4)	39.6 (32.4)	49.8 (32.4)
Change from Baseline to Endpoint	1.5 (42.9)	11.6 (42.9)	-2.1 (42.9)

MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years vs MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years: p = 0.258, ANOVA
MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years vs Pooled Placebo: p = 0.735, ANOVA
MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years vs Pooled Placebo: p = 0.194, ANOVA

Population analysed: Not all participants that were randomized had both a baseline and an endpoint urine sample. Only participants with both were included in the participants analyzed.

1 secondary outcome is reported in the full results.

Adverse events

Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
MFNS 100 or 200 mcg QD	0 of 50 (0%)	24 of 50 (48%)	Not reported
MFNS 100 or 200 mcg BID	0 of 51 (0%)	23 of 51 (45.1%)	Not reported
Placebo	0 of 26 (0%)	13 of 26 (50%)	Not reported

Limitations and caveats (from the sponsor): The standard deviation is pooled for Primary and Secondary Outcome Measures.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Results publication: PubMed 23331528Chur 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.
Individual participant dataSharing planned: No

Related trials for Nasal Polyps

RecruitingPhase 3
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RecruitingPhase 3
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RecruitingPhase 4
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Active, not recruitingPhase 3
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Active, not recruiting
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

The record lists no contact. Use the official record to reach the sponsor.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Mometasone Furoate Nasal Spray (MFNS) in people with Nasal Polyps, run by Organon and Co.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jul 2010). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change From Baseline 24-hour Urinary Free Cortisol Level (time frame: Baseline to Endpoint). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00378378, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.