Ignite Creation Date:
2024-05-05 @ 11:56 AM
Last Modification Date:
2024-10-26 @ 9:17 AM
Study NCT ID:
NCT00189462
Status:
COMPLETED
Last Update Posted:
2020-11-18
First Post:
2005-09-13
Brief Title:
A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media AOM in Children
Sponsor:
Deborah Gentile
Organization:
West Penn Allegheny Health System
Study Overview
Official Title:
A Pilot Study to Evaluate the Efficacy of Montelukast in the Treatment of Acute Otitis Media AOM in Children
Status:
COMPLETED
Status Verified Date:
2020-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 of acute Otitis media RAOM andor 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None