Acute Otitis Media: Adjuvant Therapy to Improve Outcome - Tabular View

Home

Study Topics

Glossary


	Full Text View


	Tabular View


	Contacts and Locations


	No Study Results Posted


	Related Studies

Acute Otitis Media: Adjuvant Therapy to Improve Outcome

This study has been completed.

Study NCT00000363. Last updated on April 21, 2006. Information provided by National Institute on Deafness and Other Communication Disorders (NIDCD)

This Tabular View shows the required WHO registration data elements as marked by ^†

Descriptive Information Fields

Brief Title ^†

Acute Otitis Media: Adjuvant Therapy to Improve Outcome

Official Title ^†

Brief Summary

Acute otitis media is one of the most common diseases of childhood and is one of the major causes of hearing loss in children. Despite the availability of effective antibiotic therapy for otitis media, treatment failures, persistent effusions, and recurrences are common. This Phase III outpatient study aims to test whether adjuvant therapy (an antihistamine or a corticosteroid), in addition to antibiotic therapy, improves the acute and long-term outcomes of patients with acute otitis media. This study is targeted to recruiting 200 infants (age less than one year); patient (and parent) participation is estimated to continue for one year after enrollment.

Detailed Description

Study Phase

Phase III

Study Type ^†

Interventional

Study Design ^†

Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study

Primary Outcome Measure ^†

Secondary Outcome Measure ^†

Condition ^†

Otitis Media

Intervention ^†

Drug: Antihistamine
Drug: Corticosteroid

MEDLINE PMIDs

14517524, 12633920

Links

Recruitment Information Fields

Recruitment Status ^†

Completed

Enrollment ^†

Start Date ^†

Completion Date

June 2001

Eligibility Criteria ^†

Inclusion Criteria:

Have had two documented prior episodes of acute otitis media.
Have no current middle ear effusion (fluid).

Exclusion Criteria:

Have chronic otitis media.
Have acute otitis media in addition to chronic otitis media.

Gender

Both

Ages

2 Months to 1 Year

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Administrative Information Fields

NCT ID ^†

NCT00000363

Organization ID

NIDCD-1160

Secondary IDs ^††

RO1 DC 02620-04

Study Sponsor ^†

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborators ^††

Investigators ^†

Study Chair:

Dr. Tasnee Chonmaitree

Information Provided By

National Institute on Deafness and Other Communication Disorders (NIDCD)

Verification Date

April 2006

First Received Date ^†

November 2, 1999

Last Updated Date

April 21, 2006

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.