Multicenter, Double-blind, Randomized, Placebo-controlled Study of Mometasone Furoate Nasal Spray in Pediatric Subjects With Perennial Allergic Rhinitis (Study P06332)
Information source: Merck Sharp & Dohme Corp.
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Rhinitis, Allergic, Perennial
Intervention: Mometasone furoate (Drug); Placebo (Drug)
Phase: Phase 3
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
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.
Clinical Details
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 design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Primary outcome: Change From Baseline in the Total Nasal Symptom Score at 2 Weeks
Secondary outcome: Change From Baseline in the Total Nasal Symptom Score at 1 Week
Eligibility
Minimum age: 5 Years.
Maximum age: 15 Years.
Gender(s): Both.
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.
Locations and Contacts
Additional Information
Starting date: June 2010
Last updated: March 30, 2015
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