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

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

Overview[ - collapse ][ - ]

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	Acute Otitis Media Otitis Media Ear Infection
Intervention	Drug: Montelukast
Phase	Phase 4
Sponsor	West Penn Allegheny Health System
Responsible Party	West Penn Allegheny Health System
ClinicalTrials.gov Identifier	NCT00189462
First Received	September 13, 2005
Last Updated	March 14, 2007
Last verified	March 2007

Tracking Information[ + expand ][ + ]

First Received Date	September 13, 2005
Last Updated Date	March 14, 2007
Start Date	Not Provided
Estimated Primary Completion Date	Not Provided
Current Primary Outcome Measures	Not Provided
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children
Official Title	A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children
Brief 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)
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)
Study Type	Interventional
Study Phase	Phase 4
Study Design	Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double-Blind
Condition	Acute Otitis Media Otitis Media Ear Infection
Intervention	Drug: Montelukast
Study Arm (s)	Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	Not Provided
Estimated Completion Date	Not Provided
Estimated Primary Completion Date	Not Provided
Eligibility 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
Gender	Both
Ages	18 Months
Accepts Healthy Volunteers	No
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00189462
Other Study ID Numbers	RC - 3643
Has Data Monitoring Committee	Not Provided
Information Provided By	West Penn Allegheny Health System
Study Sponsor	West Penn Allegheny Health System
Collaborators	Merck Sharp & Dohme Corp.
Investigators	Principal Investigator: David Skoner, MD West Penn Allegheny Health System
Verification Date	March 2007

Locations[ + expand ][ + ]