Back to resultsA Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children
Primary Purpose
Acute Otitis Media, Otitis Media, Ear Infection
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Montelukast
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Acute Otitis Media focused on measuring Ear Infections, Otitis Media
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
Sites / Locations
- Bellevue Pediatric Associates
- Allegheny General Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Placebo Comparator
Arm Label
Montelukast
Placebo
Arm Description
Treatment with montelukast for 4 months (4 mg per day)
Treatment with placebo for 4 months
Outcomes
Primary Outcome Measures
Incidence of Acute Otitis Media
Secondary Outcome Measures
Full Information
NCT ID
NCT00189462
First Posted
September 13, 2005
Last Updated
October 30, 2020
Sponsor
Deborah Gentile
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT00189462
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2020
Overall Recruitment Status
Completed
Study Start Date
March 2004 (undefined)
Primary Completion Date
December 2005 (Actual)
Study Completion Date
December 2005 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Deborah Gentile
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
No
5. Study Description
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)
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Otitis Media, Otitis Media, Ear Infection
Keywords
Ear Infections, Otitis Media
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
99 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Montelukast
Arm Type
Active Comparator
Arm Description
Treatment with montelukast for 4 months (4 mg per day)
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Treatment with placebo for 4 months
Intervention Type
Drug
Intervention Name(s)
Montelukast
Intervention Type
Drug
Intervention Name(s)
Placebo
Primary Outcome Measure Information:
Title
Incidence of Acute Otitis Media
Time Frame
16 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Months
Maximum Age & Unit of Time
5 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Skoner, MD
Organizational Affiliation
West Penn Allegheny Health System
Official's Role
Principal Investigator
Facility Information:
Facility Name
Bellevue Pediatric Associates
City
Bellevue
State/Province
Pennsylvania
ZIP/Postal Code
15202
Country
United States
Facility Name
Allegheny General Hospital
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15212
Country
United States
12. IPD Sharing Statement
Learn more about this trial
A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children
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