A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children
Information source: Allegheny General Hospital
Information obtained from ClinicalTrials.gov on December 31, 2007
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Acute Otitis Media; Otitis Media; Ear Infection
Intervention: Montelukast (Drug)
Phase: Phase 4
Sponsored by: Allegheny General Hospital
Official(s) and/or principal investigator(s):
David Skoner, MD, Principal Investigator, Affiliation: Allegheny General Hospital
The objective of this pilot study is to evaluate the efficacy of treatment with montelukast
as compared to placebo in the prevention of recurrence of acute Otitis media (AOM)
Official title: A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children
Study design: Randomized, Double-Blind, Placebo Control, Parallel Assignment
Otitis media (OM) is one of the most common childhood disorders requiring physician care and
has been associated with an alarming rise in prevalence. Certain children are prone to
recurrent episodes of acute Otitis media (RAOM) and/or the development of chronic Otitis
media with effusion (COME). Because medical therapy with antibiotics, antihistamines,
decongestants and corticosteroids has no demonstrable efficacy, the mainstay of treatment is
surgical intervention, which is quite expensive and exposes patients to risks of general
anesthesia. The objective of this pilot study is to evaluate the efficacy of treatment with
montelukast as compared to placebo in the prevention of recurrence of acute Otitis media
Minimum age: 18 Months.
Maximum age: 5 Years.
Aged 18 months to 5 years old.
Diagnosis of current AOM
Presence of primary or secondary immunodeficiency, craniofacial abnormality, cleft palate,
anatomic predisposition, major congenital anomaly or syndrome, or severe systemic
Any investigational medications within the past 30 days, systemic or oral or nasal steroids
within the past 30 days
Accolate® in the past 7 days
Antibiotics within the past week, except for Zithromax®, which will be 21 days
Long acting second generation antihistamines (i. e., Claritin®, Clarinex®, Allegra® and
Zyrtec®) within the past 72 hours.
No known allergy to either montelukast or amoxicillin/clavulanate
Have not responded to Augmentin® in the past
Locations and Contacts
Bellevue Pediatric Associates, Bellevue, Pennsylvania 15202, United States
Allegheny General Hospital, Pittsburgh, Pennsylvania 15212, United States
Last updated: March 14, 2007