Nasonex (Mometasone Furoate Nasal Spray) in Adenoids Hypertrophy in Children (P04367)
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: Adenoids
Intervention: mometasone furoate nasal spray (Drug)
Phase: Phase 4
Status: Completed
Sponsored by: Merck Sharp & Dohme Corp.
Summary
To document the short term & long term effect of treatment with Nasonex (mometasone furoate
nasal spray) in moderate to severe adenoids hypertrophy (which cause > 50% obstruction of
the posterior choanae).
Clinical Details
Official title: Open Label Pilot Trial, Evaluating the Role of Nasonex in the Management of Nasal Obstruction Secondary to Adenoids Hypertrophy in Children
Study design: Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Severity of Nasal Obstruction Symptoms at Baseline and Week 12 as Measured by the Total Clinical ScoreDegree of Posterior Choana Obstruction at Baseline and Week 12 Number of Participants Referred to Surgery (Adenoidectomy) Within 12 Weeks of Start of Therapy
Secondary outcome: Severity of Rhinorrhea at Baseline and Week 12Severity of Nasal Congestion at Baseline and Week 12 Severity of Nasal Itching at Baseline and Week 12 Severity of Sneezing at Baseline and Week 12 Severity of Eye Symptoms at Baseline and Week 12
Eligibility
Minimum age: 2 Years.
Maximum age: 11 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- 2-11 years of age, nasal obstruction for 3 months, adenoids hypertrophy > 50% of
posterior choanae.
Exclusion Criteria:
- adenoids hypertrophy < 50% of posterior choanae
recurrent epistaxis or immunodeficiency, severe septal deviation, kissing tonsils, choanal
atresia, large masses, known allergy to nasonex (mometasone furoate nasal spray), chronic
otitis media, cystic fibrosis, acute infection.
Locations and Contacts
Additional Information
Starting date: August 2008
Last updated: October 30, 2014
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