A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children
1 other identifier
interventional
99
1 country
2
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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Mar 2004
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
March 1, 2004
CompletedFirst Submitted
Initial submission to the registry
September 13, 2005
CompletedFirst Posted
Study publicly available on registry
September 19, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2005
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2005
CompletedResults Posted
Study results publicly available
October 8, 2014
CompletedNovember 18, 2020
October 1, 2020
1.8 years
September 13, 2005
September 23, 2014
October 30, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Incidence of Acute Otitis Media
16 weeks
Study Arms (2)
Montelukast
ACTIVE COMPARATORTreatment with montelukast for 4 months (4 mg per day)
Placebo
PLACEBO COMPARATORTreatment with placebo for 4 months
Interventions
Eligibility Criteria
You may qualify if:
- Aged 18 months to 5 years old.
- Diagnosis of current AOM
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Deborah Gentilelead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (2)
Bellevue Pediatric Associates
Bellevue, Pennsylvania, 15202, United States
Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- David Skoner, MD
- Organization
- West Penn Allegheny Health System
Study Officials
- PRINCIPAL INVESTIGATOR
David Skoner, MD
West Penn Allegheny Health System
Publication Agreements
- PI is Sponsor Employee
- No
- Restrictive Agreement
- No
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Co- Investigator, Asthma & Allergy Dept
Study Record Dates
First Submitted
September 13, 2005
First Posted
September 19, 2005
Study Start
March 1, 2004
Primary Completion
December 1, 2005
Study Completion
December 1, 2005
Last Updated
November 18, 2020
Results First Posted
October 8, 2014
Record last verified: 2020-10