CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 99 enrolled
Drug / intervention
Montelukast +1 moredrug
Likely dose
Not stated in record
Key inclusion· 2
  • ✓Age 18 months to 5 years old
  • ✓Diagnosis of current acute otitis media (AOM)
Key exclusion· 8
  • ✕Primary or secondary immunodeficiency, craniofacial abnormality, cleft palate, anatomic predisposition, major congenital anomaly or syndrome, or severe systemic disease
  • ✕Any investigational medications within the past 30 days
  • ✕Systemic, oral, or nasal steroids within the past 30 days
  • ✕Accolate (zafirlukast) within the past 7 days

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00189462
NCT00189462Phase 4Completed
CompareCT.gov

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

Deborah Gentile·interventional·Posted Sep 19, 2005·Updated Nov 18, 2020

In Brief

A Phase 4 clinical trial evaluating Montelukast and Placebo for Acute Otitis Media and 2 related conditions. Completed, enrolled 99 participants across 2 sites.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsAcute Otitis Media, Otitis Media, Ear Infection
CountriesUnited States
CollaboratorsMerck Sharp & Dohme LLC

Timeline

Phase 4CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedSep 19, 2005
Enrollment StartMar 1, 2004
Primary CompletionDec 1, 2005
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 20.8 years ago

Interventions

Montelukastdrug

Placebodrug