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

Study Type:	Interventional
Study Design:	Allocation: Randomized; Endpoint Classification: Safety Study; Intervention Model: Parallel Assignment; Masking: Double Blind (Subject, Investigator); Primary Purpose: Treatment
Condition:	Nasal Polyps
Interventions:	Drug: Mometasone Furoate Nasal Spray (MFNS) Drug: Placebo nasal spray

Participant Flow

Recruitment Details

Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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Pre-Assignment Details

Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
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Reporting Groups

	Description
MFNS 100 or 200 Mcg BID for Subjects 6 to Less Than 18 Years	Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID)
MFNS 100 or 200 Mcg QD for Subjects 6 to Less Than 18 Years	Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)
Pooled Placebo	All placebo groups were combined

Participant Flow: Overall Study

	MFNS 100 or 200 Mcg BID for Subjects 6 to Less Than 18 Years	MFNS 100 or 200 Mcg QD for Subjects 6 to Less Than 18 Years	Pooled Placebo
STARTED	51	50	26
COMPLETED	51	49	24
NOT COMPLETED	0	1	2
Withdrawal by Subject	0	1	0
Treatment Failure	0	0	1
Non-compliance with protocol	0	0	1

Baseline Characteristics

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Reporting Groups

	Description
MFNS 100 or 200 Mcg BID for Subjects 6 to Less Than 18 Years	Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID)
MFNS 100 or 200 Mcg QD for Subjects 6 to Less Than 18 Years	Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)
Pooled Placebo	All placebo groups were combined
Total	Total of all reporting groups

Baseline Measures

	MFNS 100 or 200 Mcg BID for Subjects 6 to Less Than 18 Years	MFNS 100 or 200 Mcg QD for Subjects 6 to Less Than 18 Years	Pooled Placebo	Total
Number of Participants [units: participants]	51	50	26	127
Age, Customized [units: participants]
6 to < 12 years	18	18	10	46
12 to < 18 years	33	32	16	81
Age [units: years] Mean ± Standard Deviation	9.6 ± 1.4	14.4 ± 1.8	12.7 ± 3.2	12.7 ± 2.9
Gender [units: participants]
Female	20	22	12	54
Male	31	28	14	73

Outcome Measures

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1. Primary:

Change From Baseline 24-hour Urinary Free Cortisol Level [ Time Frame: Baseline to Endpoint ]

Measure Type	Primary
Measure Title	Change From Baseline 24-hour Urinary Free Cortisol Level
Measure Description	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.
Time Frame	Baseline to Endpoint
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
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.

Reporting Groups

	Description
MFNS 100 or 200 Mcg BID for Subjects 6 to Less Than 18 Years	Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID)
MFNS 100 or 200 Mcg QD for Subjects 6 to Less Than 18 Years	Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)
Pooled Placebo	All placebo groups were combined

Measured Values

	MFNS 100 or 200 Mcg BID for Subjects 6 to Less Than 18 Years	MFNS 100 or 200 Mcg QD for Subjects 6 to Less Than 18 Years	Pooled Placebo
Number of Participants Analyzed [units: participants]	44	50	25
Change From Baseline 24-hour Urinary Free Cortisol Level [units: mcg/hour] Least Squares Mean ± Standard Deviation
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

Statistical Analysis 1 for Change From Baseline 24-hour Urinary Free Cortisol Level

Groups ^[1]	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
Method ^[2]	ANOVA
P Value ^[3]	0.258

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Pairwise comparison p-values were based on a two-way ANOVA for the change from basline
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Change From Baseline 24-hour Urinary Free Cortisol Level

Groups ^[1]	MFNS 100 or 200 Mcg BID for Subjects 6 to Less Than 18 Years vs. Pooled Placebo
Method ^[2]	ANOVA
P Value ^[3]	0.735

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Pairwise comparison p-values were based on a two-way ANOVA for the change from baseline.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 3 for Change From Baseline 24-hour Urinary Free Cortisol Level

Groups ^[1]	MFNS 100 or 200 Mcg QD for Subjects 6 to Less Than 18 Years vs. Pooled Placebo
Method ^[2]	ANOVA
P Value ^[3]	0.194

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Pairwise comparison p-values were based on a two-way ANOVA for the change from baseline.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

2. Secondary:

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

Measure Type	Secondary
Measure Title	Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine
Measure 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
Safety Issue	Yes

Population Description

Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups

	Description
MFNS 100 or 200 Mcg BID for Subjects 6 to Less Than 18 Years	Subjects 6 to less than 12 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) twice per day (BID)
MFNS 100 or 200 Mcg QD for Subjects 6 to Less Than 18 Years	Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)
Pooled Placebo	All placebo groups were combined

Measured Values

	MFNS 100 or 200 Mcg BID for Subjects 6 to Less Than 18 Years	MFNS 100 or 200 Mcg QD for Subjects 6 to Less Than 18 Years	Pooled Placebo
Number of Participants Analyzed [units: participants]	44	50	25
Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine [units: mcg/hour] Least Squares Mean ± Standard Deviation
Baseline	6.7 ± 4.5	5.3 ± 4.5	7.6 ± 4.5
Baseline to Endpoint	0.0 ± 4.9	1.0 ± 4.9	-0.6 ± 4.9

Statistical Analysis 1 for Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine

Groups ^[1]	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
Method ^[2]	ANOVA
P Value ^[3]	0.361

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Pairwise comparison p-values were based on a two-way ANOVA for baseline to endpoint
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 2 for Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine

Groups ^[1]	MFNS 100 or 200 Mcg BID for Subjects 6 to Less Than 18 Years vs. Pooled Placebo
Method ^[2]	ANOVA
P Value ^[3]	0.603

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Pairwise comparison p-values were based on a two-way ANOVA for baseline to endpoint.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Statistical Analysis 3 for Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine

Groups ^[1]	MFNS 100 or 200 Mcg QD for Subjects 6 to Less Than 18 Years vs. Pooled Placebo
Method ^[2]	ANOVA
P Value ^[3]	0.193

[1]	Additional details about the analysis, such as null hypothesis and power calculation:
	Pairwise comparison p-values were based on a two-way ANOVA for baseline to endpoint.
[2]	Other relevant information, such as adjustments or degrees of freedom:
	No text entered.
[3]	Additional information, such as whether or not the p-value is adjusted for multiple comparisons and the a priori threshold for statistical significance:
	No text entered.

Serious Adverse Events

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Other Adverse Events

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More Information

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Certain Agreements:

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

The agreement is:

	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
	Other disclosure agreement that restricts the right of the PI to discuss or publish trial results after the trial is completed.

Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
The standard deviation is pooled for Primary and Secondary Outcome Measures.

Results Point of Contact:

Name/Title: Head, Clinical Trials Registry & Results Disclosure Group
Organization: Schering-Plough
e-mail: ClinicalTrialsDisclosure@spcorp.com

No publications provided

Responsible Party:	Head, Clinical Trials Registry & Results Disclosure Group, Schering-Plough
ClinicalTrials.gov Identifier:	NCT00378378 History of Changes
Other Study ID Numbers:	P04292
Study First Received:	September 18, 2006
Results First Received:	June 24, 2009
Last Updated:	June 24, 2010
Health Authority:	United States: Food and Drug Administration