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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
David Skoner, MD, West Penn Allegheny Health System
ClinicalTrials.gov Identifier:
NCT00189462
First received: September 13, 2005
Last updated: October 13, 2014
Last verified: October 2014
History of Changes
  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 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (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

Resource links provided by NLM:

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

Further study details as provided by David Skoner, MD, West Penn Allegheny Health System:

Primary Outcome Measures:
  • Incidence of Acute Otitis Media [ Time Frame: 16 weeks ]
Enrollment: 99
Study Start Date: March 2004
Study Completion Date: December 2005
Primary Completion Date: December 2005 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Montelukast
Treatment with montelukast for 4 months (4 mg per day)
 Drug: Montelukast
Placebo Comparator: Placebo
Treatment with placebo for 4 months

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   (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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Sharp & Dohme Corp.
Investigators
Principal Investigator: David Skoner, MD West Penn Allegheny Health System
  More Information

Responsible Party: David Skoner, MD, Principal Investigator, Director, Asthma & Allergy Dept, West Penn Allegheny Health System
ClinicalTrials.gov Identifier: NCT00189462     History of Changes
Other Study ID Numbers: RC - 3643
Study First Received: September 13, 2005
Results First Received: September 23, 2014
Last Updated: October 13, 2014

Keywords provided by David Skoner, MD, West Penn Allegheny Health System:
Ear Infections
Otitis Media

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on May 25, 2017