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

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ClinicalTrials.gov Identifier: NCT00189462
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : October 8, 2014
Last Update Posted : November 18, 2020
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Deborah Gentile, West Penn Allegheny Health System

Study Description
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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)

Condition or disease Intervention/treatment Phase
Acute Otitis Media Otitis Media Ear Infection Drug: Montelukast Drug: Placebo Phase 4

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 99 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Prevention
Official Title: A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children
Study Start Date : March 2004
Actual Primary Completion Date : December 2005
Actual Study Completion Date : December 2005

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections
Drug Information available for: Montelukast

Arms and Interventions
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Arm Intervention/treatment
Active Comparator: Montelukast
Treatment with montelukast for 4 months (4 mg per day)
 Drug: Montelukast
Placebo Comparator: Placebo
Treatment with placebo for 4 months
 Drug: Placebo


Outcome Measures
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Primary Outcome Measures :
  1. Incidence of Acute Otitis Media [ Time Frame: 16 weeks ]

Eligibility Criteria
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Ages Eligible for Study:   18 Months to 5 Years   (Child)
Sexes Eligible for Study:   All
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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00189462


Locations
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United States, Pennsylvania
Bellevue Pediatric Associates
Bellevue, Pennsylvania, United States, 15202
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212
Sponsors and Collaborators
Deborah Gentile
Merck Sharp & Dohme Corp.
Investigators
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Principal Investigator: David Skoner, MD West Penn Allegheny Health System
More Information
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Responsible Party: Deborah Gentile, Co- Investigator, Asthma & Allergy Dept, West Penn Allegheny Health System
ClinicalTrials.gov Identifier: NCT00189462    
Other Study ID Numbers: RC - 3643
First Posted: September 19, 2005    Key Record Dates
Results First Posted: October 8, 2014
Last Update Posted: November 18, 2020
Last Verified: October 2020
Keywords provided by Deborah Gentile, West Penn Allegheny Health System:
Ear Infections
Otitis Media
Additional relevant MeSH terms:
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Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Montelukast
Anti-Asthmatic Agents
Respiratory System Agents
 Leukotriene Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP1A2 Inducers
Cytochrome P-450 Enzyme Inducers
Molecular Mechanisms of Pharmacological Action