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

• Status: Completed
• Trial end date: 2005-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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)

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Deborah Gentile; West Penn Allegheny Health System
• Collaborator: Merck Sharp & Dohme Corp.
• Treatments: Montelukast

Criteria

Inclusion Criteria:

• Aged 18 months to 5 years old.

• Diagnosis of current AOM

Exclusion Criteria:

• 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