A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children

Completed · Phase 4 · Has a placebo group

Conditions studied: Acute Otitis Media, Otitis Media, Ear Infection

In brief

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)

Key facts

Study ID

NCT00189462

Run by

Deborah Gentile

People needed

99

Starts

2004-03-01

Expected to finish

2005-12-01

Last updated by the study team

2020-11-18

Who can join

Age: 2 and older, up to 5. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Aged 18 months to 5 years old.
• Diagnosis of current AOM

You may not qualify if…

• Presence of primary or secondary immunodeficiency, craniofacial abnormality, cleft palate, anatomic predisposition, major congenital anomaly or syndrome, or severe systemic disease
• Use of:
• 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

Where it is running

• Bellevue Pediatric Associates — Bellevue, Pennsylvania, United States
• Allegheny General Hospital — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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