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

September 13, 2005
October 13, 2014
March 2004
December 2005   (final data collection date for primary outcome measure)
Incidence of Acute Otitis Media [ Time Frame: 16 weeks ] [ Designated as safety issue: No ]
Not Provided
Complete list of historical versions of study NCT00189462 on ClinicalTrials.gov Archive Site
Not Provided
Not Provided
Not Provided
Not Provided
 
A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children
A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children

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)

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)

Interventional
Phase 4
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Prevention
  • Acute Otitis Media
  • Otitis Media
  • Ear Infection
Drug: Montelukast
  • Active Comparator: Montelukast
    Treatment with montelukast for 4 months (4 mg per day)
    Intervention: Drug: Montelukast
  • Placebo Comparator: Placebo
    Treatment with placebo for 4 months
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
99
December 2005
December 2005   (final data collection date for primary outcome measure)

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
Both
18 Months to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00189462
RC - 3643
No
David Skoner, MD, West Penn Allegheny Health System
West Penn Allegheny Health System
Merck Sharp & Dohme Corp.
Principal Investigator: David Skoner, MD West Penn Allegheny Health System
West Penn Allegheny Health System
October 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP