Phase 4
N=99
A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media (AOM) in Children
Acute Otitis Media · Otitis Media · Ear Infection
Bottom Line
View on ClinicalTrials.gov: NCT00189462 ↗Enrolled (actual)
99
Serious AEs
0.0%
Results posted
Oct 2014
Primary outcome: Primary: Incidence of Acute Otitis Media — 30; 27 participants with AOM
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 4
- Interventions
- Montelukast (Drug); Placebo (Drug)
- Age
- Pediatric · 0+ yrs
- Sex
- All
- Sponsor
- Deborah Gentile
- Primary completion
- Dec 2005
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Incidence of Acute Otitis Media |
30; 27 | — |
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)
Eligibility 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
Data sourced from ClinicalTrials.gov (NCT00189462). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.