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 on September 13, 2005. Last Updated on March 14, 2007 History of Changes

Sponsor:	West Penn Allegheny Health System
Collaborator:	Merck
Information provided by:	West Penn Allegheny Health System
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

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

Resource links provided by NLM:

MedlinePlus related topics: Ear Infections

Drug Information available for: Montelukast sodium Montelukast

U.S. FDA Resources

Further study details as provided by West Penn Allegheny Health System:

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

West Penn Allegheny Health System

Merck

Investigators

Principal Investigator:

David Skoner, MD

West Penn Allegheny Health System

More Information

No publications provided

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

Keywords provided by West Penn Allegheny Health System:

Ear Infections
Otitis Media

Additional relevant MeSH terms:

Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Montelukast
Leukotriene Antagonists
Hormone Antagonists

Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Pharmacologic Actions
Anti-Asthmatic Agents
Respiratory System Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on February 09, 2012