Trial Outcomes & Findings for Study of Nasonex® for the Treatment of Nasal Polyps in Pediatric Subjects Between Ages of 6 and Less Than 18 Years Old (P04292) (NCT NCT00378378)

Last Updated: 2024-05-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

127 participants

Primary outcome timeframe

Baseline to Endpoint

Results posted on

2024-05-20

Participant Flow

Participant milestones

Participant milestones
Measure	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
Overall Study STARTED	51	50	26
Overall Study COMPLETED	51	49	24
Overall Study NOT COMPLETED	0	1	2

Reasons for withdrawal

Reasons for withdrawal
Measure	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
Overall Study Withdrawal by Subject	1	0
Overall Study Treatment Failure	0	1
Overall Study Non-compliance with protocol	0	1

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years n=51 Participants 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 n=50 Participants Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)	Pooled Placebo n=26 Participants All placebo groups were combined	Total n=127 Participants Total of all reporting groups
Age, Continuous	9.6 years STANDARD_DEVIATION 1.4 • n=5 Participants	14.4 years STANDARD_DEVIATION 1.8 • n=7 Participants	12.7 years STANDARD_DEVIATION 3.2 • n=5 Participants	12.7 years STANDARD_DEVIATION 2.9 • n=4 Participants
Age, Customized 6 to < 12 years	18 participants n=5 Participants	18 participants n=7 Participants	10 participants n=5 Participants	46 participants n=4 Participants
Age, Customized 12 to < 18 years	33 participants n=5 Participants	32 participants n=7 Participants	16 participants n=5 Participants	81 participants n=4 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	22 Participants n=7 Participants	12 Participants n=5 Participants	54 Participants n=4 Participants
Sex: Female, Male Male	31 Participants n=5 Participants	28 Participants n=7 Participants	14 Participants n=5 Participants	73 Participants n=4 Participants

PRIMARY outcome

Timeframe: Baseline to Endpoint

Population: 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.

Outcome measures

Outcome measures
Measure	MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years n=44 Participants 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 n=50 Participants Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)	Pooled Placebo n=25 Participants All placebo groups were combined
Change From Baseline 24-hour Urinary Free Cortisol Level Baseline	49.5 mcg/hour Standard Deviation 32.4	39.6 mcg/hour Standard Deviation 32.4	49.8 mcg/hour Standard Deviation 32.4
Change From Baseline 24-hour Urinary Free Cortisol Level Change from Baseline to Endpoint	1.5 mcg/hour Standard Deviation 42.9	11.6 mcg/hour Standard Deviation 42.9	-2.1 mcg/hour Standard Deviation 42.9

SECONDARY outcome

Timeframe: Baseline to Endpoint

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

Outcome measures

Outcome measures
Measure	MFNS 100 or 200 mcg BID for Subjects 6 to Less Than 18 Years n=44 Participants 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 n=50 Participants Subject 12 to less than 18 years of age were pooled for Mometasone Furoate Nasal Spray (MFNS) once per day (QD)	Pooled Placebo n=25 Participants All placebo groups were combined
Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine Baseline	6.7 mcg/hour Standard Deviation 4.5	5.3 mcg/hour Standard Deviation 4.5	7.6 mcg/hour Standard Deviation 4.5
Change From Baseline 24-hour Urinary Free Cortisol Level Corrected for Creatinine Baseline to Endpoint	0.0 mcg/hour Standard Deviation 4.9	1.0 mcg/hour Standard Deviation 4.9	-0.6 mcg/hour Standard Deviation 4.9

Adverse Events

MFNS 100 or 200 mcg QD

Serious events: 0 serious events

Other events: 24 other events

Deaths: 0 deaths

MFNS 100 or 200 mcg BID

Serious events: 0 serious events

Other events: 23 other events

Deaths: 0 deaths

Placebo

Serious events: 0 serious events

Other events: 13 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Other adverse events
Measure	MFNS 100 or 200 mcg QD n=50 participants at risk	MFNS 100 or 200 mcg BID n=51 participants at risk	Placebo n=26 participants at risk
Ear and labyrinth disorders EAR PAIN	6.0% 3/50 • Number of events 6	2.0% 1/51 • Number of events 4	0.00% 0/26
General disorders PYREXIA	2.0% 1/50 • Number of events 1	5.9% 3/51 • Number of events 3	3.8% 1/26 • Number of events 2
Infections and infestations INFLUENZA	8.0% 4/50 • Number of events 4	7.8% 4/51 • Number of events 6	3.8% 1/26 • Number of events 1
Infections and infestations NASOPHARYNGITIS	12.0% 6/50 • Number of events 6	11.8% 6/51 • Number of events 6	23.1% 6/26 • Number of events 8
Infections and infestations VIRAL UPPER RESPIRATORY TRACT INFECTION	2.0% 1/50 • Number of events 1	3.9% 2/51 • Number of events 4	7.7% 2/26 • Number of events 2
Nervous system disorders HEADACHE	24.0% 12/50 • Number of events 32	19.6% 10/51 • Number of events 22	30.8% 8/26 • Number of events 14
Respiratory, thoracic and mediastinal disorders EPISTAXIS	6.0% 3/50 • Number of events 7	11.8% 6/51 • Number of events 32	3.8% 1/26 • Number of events 3
Respiratory, thoracic and mediastinal disorders NASAL DISCOMFORT	2.0% 1/50 • Number of events 2	0.00% 0/51	7.7% 2/26 • Number of events 2
Respiratory, thoracic and mediastinal disorders PHARYNGOLARYNGEAL PAIN	6.0% 3/50 • Number of events 10	2.0% 1/51 • Number of events 2	3.8% 1/26 • Number of events 3

Additional Information

Senior Vice Presiden, Global Clinical Development

Merck, Sharp & Dohme Corp.

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Restriction type: LTE60