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

This study has been completed.

First Received: September 13, 2005 Last Updated: March 14, 2007 History of Changes

Sponsors and Collaborators:	Allegheny General Hospital Merck
Information provided by:	Allegheny General Hospital
ClinicalTrials.gov Identifier:	NCT00189462

Purpose

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)

Condition	Intervention	Phase
Acute Otitis Media Otitis Media Ear Infection	Drug: Montelukast	Phase IV

MedlinePlus related topics: Ear Infections

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Randomized, Double-Blind, Placebo Control, Parallel Assignment
Official Title:	A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children

Further study details as provided by Allegheny General Hospital:

Detailed 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)

Eligibility

Ages Eligible for Study:	18 Months to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00189462

Locations

United States, Pennsylvania
Bellevue Pediatric Associates
Bellevue, Pennsylvania, United States, 15202
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212

Sponsors and Collaborators

Allegheny General Hospital

Merck

Investigators

Principal Investigator:

David Skoner, MD

Allegheny General Hospital

More Information

No publications provided

Study ID Numbers:	RC - 3643
Study First Received:	September 13, 2005
Last Updated:	March 14, 2007
ClinicalTrials.gov Identifier:	NCT00189462 History of Changes
Health Authority:	United States: Institutional Review Board

Keywords provided by Allegheny General Hospital:

Ear Infections
Otitis Media

Study placed in the following topic categories:

Montelukast
Otorhinolaryngologic Diseases
Hormone Antagonists
Otitis
Hormones, Hormone Substitutes, and Hormone Antagonists

Otitis Media
Anti-Asthmatic Agents
Hormones
Ear Diseases
Leukotriene Antagonists

Additional relevant MeSH terms:

Respiratory System Agents
Otorhinolaryngologic Diseases
Hormone Antagonists
Physiological Effects of Drugs
Otitis Media
Hormones, Hormone Substitutes, and Hormone Antagonists
Anti-Asthmatic Agents

Infection
Ear Diseases
Pharmacologic Actions
Leukotriene Antagonists
Montelukast
Therapeutic Uses
Otitis

ClinicalTrials.gov processed this record on May 07, 2009