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NCT00189462 Clinical Trial

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

Otitis Media Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00189462
Other study ID # RC - 3643
Secondary ID
Status Completed
Phase Phase 4
First received
Last updated
Start date March 2004
Est. completion date December 2005

Study information
Verified date October 2020
Source West Penn Allegheny Health System
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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)

Description:

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 (AOM)

Recruitment information / eligibility
Status Completed
Enrollment 99
Est. completion date December 2005
Est. primary completion date December 2005
Accepts healthy volunteers No
Gender All
Age group 18 Months to 5 Years
Eligibility 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

Study Design

Related Conditions & MeSH terms

Intervention

Drug:
• Montelukast

• Placebo

Locations
Country Name City State
United States Bellevue Pediatric Associates Bellevue Pennsylvania
United States Allegheny General Hospital Pittsburgh Pennsylvania

Sponsors (2)
Lead Sponsor Collaborator
Deborah Gentile Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Incidence of Acute Otitis Media 16 weeks
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