Status:
COMPLETED
A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children
Lead Sponsor:
Deborah Gentile
Collaborating Sponsors:
Merck Sharp & Dohme LLC
Conditions:
Acute Otitis Media
Otitis Media
Eligibility:
All Genders
18-5 years
Phase:
PHASE4
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 o...
Eligibility Criteria
Inclusion
- Aged 18 months to 5 years old.
- Diagnosis of current AOM
Exclusion
- 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
Key Trial Info
Start Date :
March 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2005
Estimated Enrollment :
99 Patients enrolled
Trial Details
Trial ID
NCT00189462
Start Date
March 1 2004
End Date
December 1 2005
Last Update
November 18 2020
Active Locations (2)
Enter a location and click search to find clinical trials sorted by distance.
1
Bellevue Pediatric Associates
Bellevue, Pennsylvania, United States, 15202
2
Allegheny General Hospital
Pittsburgh, Pennsylvania, United States, 15212