Back to resultsMulticenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06332)
Primary Purpose
Rhinitis, Allergic, Perennial
Status
Completed
Phase
Phase 3
Locations
Study Type
Interventional
Intervention
Mometasone furoate
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Rhinitis, Allergic, Perennial
Eligibility Criteria
Inclusion Criteria:
Pediatric subjects with perennial allergic rhinitis who satisfy all of the following main criteria:
- Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree, after the pretreatment observation period.
- Subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust-mite antigen).
- Male or female outpatients aged 5 to 15 years at the time of providing informed consent.
Exclusion Criteria:
Subjects for whom any of the main exclusion criteria below is applicable will not be registered in this study.
- Subjects with coexisting tuberculous disease or lower respiratory tract infection and subjects who have a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) requiring treatment at the time of registration
- Subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics
- Subjects with repeated epistaxis
- Subjects who have nasal septum ulcers, nasal surgery, or nasal trauma, which have not healed
- Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor
- Subjects with complication of vasomotor rhinitis or eosinophilic rhinitis.
- Subjects with nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Mometasone furoate nasal spray (MFNS) (50 μg spray device)
MF placebo nasal spray
Arm Description
The dose will be as follows: 5 to 11 years: one spray per nostril once daily (100 μg/day as MF) in the morning for 2 weeks 12 to 15 years: 2 sprays per nostril once daily (200 μg/day as MF) in the morning for 2 weeks
Administration will be as follows: 5 to 11 years: one spray per nostril once daily in the morning for 2 weeks 12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks
Outcomes
Primary Outcome Measures
Change From Baseline in the Total Nasal Symptom Score at 2 Weeks
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, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.
Secondary Outcome Measures
Change From Baseline in the Total Nasal Symptom Score at 1 Week
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, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01135134
Brief Title
Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06332)
Official Title
Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Protocol No.P06332)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
June 2010 (undefined)
Primary Completion Date
October 2010 (Actual)
Study Completion Date
October 2010 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Organon and Co
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This is a multicenter, randomized, parallel design, double-blind study of mometasone furoate (MF) in pediatric subjects with perennial allergic rhinitis. The subjects 5 to 15 years of age with perennial allergic rhinitis will enter a no-treatment observation period of 7 days at minimum and eligibility for inclusion in this study will be assessed. Following the observation period, eligible subjects will be randomized to MF or MF placebo for a 2-week double-blind treatment. At each clinic visit (at the start of treatment and after 1 and 2 weeks of treatment or at discontinuation), nasal symptom scores, nasal findings, and adverse events (AEs), will be evaluated. A 30-day follow-up visit will take place after the completion (or discontinuation) of the 2-week treatment period, to confirm presence or absence of serious adverse events (SAEs) and trial procedure-related AEs.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Rhinitis, Allergic, Perennial
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
333 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Mometasone furoate nasal spray (MFNS) (50 μg spray device)
Arm Type
Experimental
Arm Description
The dose will be as follows:
5 to 11 years: one spray per nostril once daily (100 μg/day as MF) in the morning for 2 weeks
12 to 15 years: 2 sprays per nostril once daily (200 μg/day as MF) in the morning for 2 weeks
Arm Title
MF placebo nasal spray
Arm Type
Placebo Comparator
Arm Description
Administration will be as follows:
5 to 11 years: one spray per nostril once daily in the morning for 2 weeks
12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Mometasone furoate
Other Intervention Name(s)
Nasonex
Intervention Description
The study drug is MFNS (50 μg spray device) and the dose will be:
5 to 11 years: one spray per nostril once daily (100 μg/day as MF) in the morning for 2 weeks
12 to 15 years: 2 sprays per nostril once daily (200 μg/day as MF) in the morning for 2 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
MF Placebo nasal spray and administration will be as follows:
5 to 11 years: one spray per nostril once daily in the morning for 2 weeks
12 to 15 years: 2 sprays per nostril once daily in the morning for 2 weeks
Primary Outcome Measure Information:
Title
Change From Baseline in the Total Nasal Symptom Score at 2 Weeks
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, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.
Time Frame
Baseline and 2 weeks (or discontinuation)
Secondary Outcome Measure Information:
Title
Change From Baseline in the Total Nasal Symptom Score at 1 Week
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, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.
Time Frame
Baseline and 1 week
10. Eligibility
Sex
All
Minimum Age & Unit of Time
5 Years
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Pediatric subjects with perennial allergic rhinitis who satisfy all of the following main criteria:
Subjects having symptoms of perennial allergic rhinitis of moderate to severe degree, after the pretreatment observation period.
Subjects confirmed to be allergic to non-seasonal environmental antigens (e.g., house dust-mite antigen).
Male or female outpatients aged 5 to 15 years at the time of providing informed consent.
Exclusion Criteria:
Subjects for whom any of the main exclusion criteria below is applicable will not be registered in this study.
Subjects with coexisting tuberculous disease or lower respiratory tract infection and subjects who have a nasopharyngolaryngeal infection (acute upper respiratory tract infection, acute pharyngolaryngitis, or acute tonsillitis, etc.) requiring treatment at the time of registration
Subjects with coexisting infections or systemic mycosis for which there are no effective antibiotics
Subjects with repeated epistaxis
Subjects who have nasal septum ulcers, nasal surgery, or nasal trauma, which have not healed
Subjects with severe hepatic, renal, cardiac, hematological disease, diabetes mellitus, hypertension, or other serious coexisting diseases and whose general condition is poor
Subjects with complication of vasomotor rhinitis or eosinophilic rhinitis.
Subjects with nasal conditions (infectious sinusitis, hypertrophic rhinitis, acute or chronic rhinitis, nasal polyps, septal deviation, etc.) which may interfere with the evaluation of the efficacy of the study drug.
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
http://www.merck.com/clinical-trials/pdf/Merck%20Procedure%20on%20Clinical%20Trial%20Data%20Access%20Final_Updated%20July_9_2014.pdf
http://engagezone.msd.com/ds_documentation.php
Citations:
Citation
Okamoto Y, Suzuki I . Multicenter, double-blind, randomized, placebo-controlled study of mometasone furoate nasal spray in Japanese pediatric subjects with perennial allergic rhinitis . Oto-rhino Laryngol Tokyo. 2013;106(11):1045-1057.
Results Reference
result
Learn more about this trial
Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06332)
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