Trial · NCT00378378

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

NCT00378378, Phase 3, Completed, Organon and Co; results first posted 2010-07-20

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old (P04292). Trials, record NCT00378378. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT00378378

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old (P04292)
NCT number: NCT00378378
Status: Completed
Phases: Phase 3
Enrollment: 127 participants, actual
Lead sponsor: Organon and Co
Conditions: Nasal Polyps
Interventions: Mometasone Furoate Nasal Spray (MFNS), Placebo nasal spray
First posted: 2006-09-20
Last updated: 2024-05-20
Results first posted: 2010-07-20
Limitations and caveats: The standard deviation is pooled for Primary and Secondary Outcome Measures.

Source ClinicalTrials.gov

Registered outcomes2

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Change From Baseline 24-hour Urinary Free Cortisol Level	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.
Secondary	Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine	Baseline to Endpoint	The key secondary objective of this study was the assessment of the 24-hour urinary free cortisol level (corrected for creatinine).

Source ClinicalTrials.gov

Outcomes2

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Change From Baseline 24-hour Urinary Free Cortisol Level	Baseline to Endpoint	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.	mcg/hour	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine	Baseline to Endpoint		mcg/hour	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group12

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Category	Value	Spread	Units
Change From Baseline 24-hour Urinary Free Cortisol Level	MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years	Baseline	49.5	Standard Deviation 32.4	mcg/hour
Change From Baseline 24-hour Urinary Free Cortisol Level	MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years	Baseline	39.6	Standard Deviation 32.4	mcg/hour
Change From Baseline 24-hour Urinary Free Cortisol Level	Pooled Placebo	Baseline	49.8	Standard Deviation 32.4	mcg/hour
Change From Baseline 24-hour Urinary Free Cortisol Level	MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years	Change from Baseline to Endpoint	1.5	Standard Deviation 42.9	mcg/hour
Change From Baseline 24-hour Urinary Free Cortisol Level	MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years	Change from Baseline to Endpoint	11.6	Standard Deviation 42.9	mcg/hour
Change From Baseline 24-hour Urinary Free Cortisol Level	Pooled Placebo	Change from Baseline to Endpoint	-2.1	Standard Deviation 42.9	mcg/hour
Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine	MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years	Baseline	6.7	Standard Deviation 4.5	mcg/hour
Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine	MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years	Baseline	5.3	Standard Deviation 4.5	mcg/hour
Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine	Pooled Placebo	Baseline	7.6	Standard Deviation 4.5	mcg/hour
Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine	MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years	Baseline to Endpoint	0.0	Standard Deviation 4.9	mcg/hour

1 to 10 of 12Source ClinicalTrials.gov

See all 12 results by group

Participant flow9

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years	51
Overall Study	STARTED	MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years	50
Overall Study	STARTED	Pooled Placebo	26
Overall Study	COMPLETED	MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years	51
Overall Study	COMPLETED	MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years	49
Overall Study	COMPLETED	Pooled Placebo	24
Overall Study	NOT COMPLETED	MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years	0
Overall Study	NOT COMPLETED	MFNS 100 or 200 mcg QD for Subjects 6 to Less Than 18 Years	1
Overall Study	NOT COMPLETED	Pooled Placebo	2

Source ClinicalTrials.gov

Adverse events27

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

Type	Event	Organ system	Group	Affected	At risk	Events
other	EAR PAIN	Ear and labyrinth disorders	MFNS 100 or 200 mcg QD	3	50	6
other	EAR PAIN	Ear and labyrinth disorders	MFNS 100 or 200 mcg BID	1	51	4
other	EAR PAIN	Ear and labyrinth disorders	Placebo	0	26	0
other	PYREXIA	General disorders	MFNS 100 or 200 mcg QD	1	50	1
other	PYREXIA	General disorders	MFNS 100 or 200 mcg BID	3	51	3
other	PYREXIA	General disorders	Placebo	1	26	2
other	INFLUENZA	Infections and infestations	MFNS 100 or 200 mcg QD	4	50	4
other	INFLUENZA	Infections and infestations	MFNS 100 or 200 mcg BID	4	51	6
other	INFLUENZA	Infections and infestations	Placebo	1	26	1
other	NASOPHARYNGITIS	Infections and infestations	MFNS 100 or 200 mcg QD	6	50	6

1 to 10 of 27Source ClinicalTrials.gov

See all 27 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	MFNS 100 or 200 mcg QD
Total, all-cause mortality	MFNS 100 or 200 mcg BID
Total, all-cause mortality	Placebo
Total, other adverse events	MFNS 100 or 200 mcg QD	24	50
Total, other adverse events	MFNS 100 or 200 mcg BID	23	51
Total, other adverse events	Placebo	13	26
Total, serious adverse events	MFNS 100 or 200 mcg QD	0	50
Total, serious adverse events	MFNS 100 or 200 mcg BID	0	51
Total, serious adverse events	Placebo	0	26

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
23331528	RESULT

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT00378378

GET https://conductscience.org/api/trials/v1/NCT00378378/events?page=2

API reference For AI assistants