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

NCT ID: NCT00189462

Last Updated: 2020-11-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

99 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-03-31

Study Completion Date

2005-12-31

Brief Summary

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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)

Detailed Description

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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)

Conditions

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Acute Otitis Media Otitis Media Ear Infection

Keywords

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Ear Infections Otitis Media

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Montelukast

Treatment with montelukast for 4 months (4 mg per day)

Group Type ACTIVE_COMPARATOR

Montelukast

Intervention Type DRUG

Placebo

Treatment with placebo for 4 months

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Interventions

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Montelukast

Intervention Type DRUG

Placebo

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Months

Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

Deborah Gentile

OTHER

Sponsor Role lead

Responsible Party

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Deborah Gentile

Co- Investigator, Asthma & Allergy Dept

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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David Skoner, MD

Role: PRINCIPAL_INVESTIGATOR

West Penn Allegheny Health System

Locations

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Bellevue Pediatric Associates

Bellevue, Pennsylvania, United States

Site Status

Allegheny General Hospital

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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RC - 3643

Identifier Type: -

Identifier Source: org_study_id