Clinical Trial Results:
A study of long-term (12-24 weeks) administration of mometasone furoate nasal spray in pediatric subjects with perennial allergic rhinitis (Protocol No. P06333)
Summary
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EudraCT number |
2014-004922-16 |
Trial protocol |
Outside EU/EEA |
Global end of trial date |
28 Dec 2010
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Results information
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Results version number |
v1(current) |
This version publication date |
16 Feb 2016
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First version publication date |
15 Jul 2015
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Other versions |
Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information
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Trial identification
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Sponsor protocol code |
P06333
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Additional study identifiers
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ISRCTN number |
- | ||
US NCT number |
NCT01165424 | ||
WHO universal trial number (UTN) |
- | ||
Other trial identifiers |
Protocol number: MK-0887-175 | ||
Sponsors
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Sponsor organisation name |
Merck Sharp & Dohme Corp.
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Sponsor organisation address |
2000 Galloping Hill Road, Kenilworth, NJ, United States, 07033
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Public contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Scientific contact |
Clinical Trials Disclosure, Merck Sharp & Dohme Corp., ClinicalTrialsDisclosure@merck.com
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Paediatric regulatory details
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Is trial part of an agreed paediatric investigation plan (PIP) |
No
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Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial? |
No
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Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial? |
Yes
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Results analysis stage
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Analysis stage |
Final
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Date of interim/final analysis |
28 Dec 2010
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Is this the analysis of the primary completion data? |
Yes
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Primary completion date |
28 Dec 2010
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Global end of trial reached? |
Yes
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Global end of trial date |
28 Dec 2010
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Was the trial ended prematurely? |
No
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General information about the trial
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Main objective of the trial |
Mometasone furoate nasal spray (MFNS) is a once-a-day product. This is a multi-center, open-label study of MFNS in children with perennial allergic rhinitis. MFNS will be administered to pediatric participants (3-15 years old) with perennial allergic rhinitis at a dose of 100 to 200 μg/day (once daily) for 12 weeks. Participants (participant's legal representatives) provided consent to continue treatment beyond 12 weeks will receive treatment for up to 24 weeks. At each clinic visit, observation of adverse events, nasal symptom scores, and nasal findings will be evaluated. The presence/absence of serious adverse events and trial procedure-related AEs will be reviewed 30 days after the end of the follow-up.
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Protection of trial subjects |
This study was conducted in conformance with Good Clinical Practice standards and applicable country and/or local statutes and regulations regarding ethical committee review, informed consent, and the protection of human subjects participating in biomedical research.
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Background therapy |
- | ||
Evidence for comparator |
- | ||
Actual start date of recruitment |
08 Apr 2010
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Long term follow-up planned |
No
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Independent data monitoring committee (IDMC) involvement? |
No
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Population of trial subjects
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Number of subjects enrolled per country |
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Country: Number of subjects enrolled |
Japan: 80
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Worldwide total number of subjects |
80
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EEA total number of subjects |
0
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Number of subjects enrolled per age group |
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In utero |
0
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Preterm newborn - gestational age < 37 wk |
0
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Newborns (0-27 days) |
0
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Infants and toddlers (28 days-23 months) |
0
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Children (2-11 years) |
56
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Adolescents (12-17 years) |
24
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Adults (18-64 years) |
0
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From 65 to 84 years |
0
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85 years and over |
0
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Recruitment
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Recruitment details |
This study was performed at 7 clinical sites in Japan. | ||||||||||||||||
Pre-assignment
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Screening details |
Ninety-eight participants were tentatively enrolled after giving consent. Of these, 80 who satisfied the eligibility criteria after the pretreatment observation period of at least 7 days were registered. | ||||||||||||||||
Period 1
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Period 1 title |
Treatment Period (overall period)
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Is this the baseline period? |
Yes | ||||||||||||||||
Allocation method |
Non-randomised - controlled
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Blinding used |
Not blinded | ||||||||||||||||
Arms
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Arm title
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Mometasone furoate nasal spray | ||||||||||||||||
Arm description |
Mometasone furoate (MFNS) 50 μg spray device. For participants aged 3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning for up to 24 weeks and for participant aged 12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning for up to 24 weeks. | ||||||||||||||||
Arm type |
Experimental | ||||||||||||||||
Investigational medicinal product name |
Mometasone furoate nasal spray
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Investigational medicinal product code |
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Other name |
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Pharmaceutical forms |
Nasal spray
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Routes of administration |
Nasal use
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Dosage and administration details |
Mometasone furoate (MFNS) 50 μg spray device. For participants aged 3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning for up to 24 weeks and for participant aged 12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning for up to 24 weeks.
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Baseline characteristics reporting groups
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Reporting group title |
Treatment Period
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Reporting group description |
Mometasone furoate (MFNS) 50 μg spray device. For participants aged 3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning for up to 24 weeks and for participant aged 12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning for up to 24 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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End points reporting groups
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Reporting group title |
Mometasone furoate nasal spray
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Reporting group description |
Mometasone furoate (MFNS) 50 μg spray device. For participants aged 3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning for up to 24 weeks and for participant aged 12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning for up to 24 weeks. |
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End point title |
Number of Participants With Adverse Events and Adverse Drug Reactions [1] | ||||||||||
End point description |
An adverse event (AE) is defined as any unfavorable and unintended sign including an abnormal laboratory finding, symptom or disease associated with the use of a medical treatment or procedure, regardless of whether it is considered related to the medical treatment or procedure, that occurs during the course of the study. Adverse drug reactions are all noxious and unintended responses to a medicinal product related to any dose.
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End point type |
Primary
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End point timeframe |
Up to 28 weeks
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Notes [1] - No statistical analyses have been specified for this primary end point. It is expected there is at least one statistical analysis for each primary end point. Justification: No statistical analysis was performed with this primary endpoint as there was only a single study arm and the data was in the form of number of participants with no statistical analysis. |
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No statistical analyses for this end point |
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End point title |
Change From Baseline in the Total Nasal Symptom Score | ||||||||||||||||||||||||
End point description |
Total nasal symptom score was a composite of 4 symptoms (sneezing, rhinorrhea, nasal congestion, and nasal itching). Each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, and 3 = severe for a total score ranging from 0 to 12. A higher score indicates more severe symptoms.
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End point type |
Secondary
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End point timeframe |
Baseline and Weeks 2, 4, 8, 12, 16, 20, and 24 (or discontinuation)
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No statistical analyses for this end point |
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Adverse events information
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Timeframe for reporting adverse events |
Up to 214 days
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Assessment type |
Systematic | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary used for adverse event reporting
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Dictionary name |
MedDRA | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
Dictionary version |
13.0
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Reporting groups
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Reporting group title |
MFNS
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Reporting group description |
MFNS 50 μg spray device. For participants aged 3 to 11 years: one spray per nostril once daily (100 μg/day) in the morning for up to 24 weeks and for participant aged 12 to 15 years: 2 sprays per nostril once daily (200 μg/day) in the morning for up to 24 weeks. | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Frequency threshold for reporting non-serious adverse events: 5% | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
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Substantial protocol amendments (globally) |
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Were there any global substantial amendments to the protocol? No | |||
Interruptions (globally) |
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Were there any global interruptions to the trial? No | |||
Limitations and caveats |
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Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data. | |||
None reported |