NCT00189462

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 99 (actual)
• Sponsor: Deborah Gentile · Academic / Other
• Sex: All
• Age: 18 Months – 5 Years
• Healthy volunteers: Not accepted

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 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)

Conditions

• Acute Otitis Media
• Otitis Media
• Ear Infection

Interventions

Type	Name	Description
DRUG	Montelukast
DRUG	Placebo

Timeline

• Start date: 2004-03-01
• Primary completion: 2005-12-01
• Completion: 2005-12-01
• First posted: 2005-09-19
• Last updated: 2020-11-18
• Results posted: 2014-10-08

Locations

2 sites across 1 country: United States