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

Tracking Information

First Received Date ^ICMJE

November 2, 1999

Last Updated Date

April 21, 2006

Start Date ^ICMJE

Primary Completion Date

Current Primary Outcome Measures ^ICMJE

Original Primary Outcome Measures ^ICMJE

Change History

Complete list of historical versions of study NCT00000363 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Original Secondary Outcome Measures ^ICMJE

Descriptive Information

Brief Title ^ICMJE

Acute Otitis Media: Adjuvant Therapy to Improve Outcome

Official Title ^ICMJE

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 ^ICMJE

Interventional

Study Design ^ICMJE

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

Condition ^ICMJE

Otitis Media

Intervention ^ICMJE

Drug: Antihistamine
Drug: Corticosteroid

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Completed

Enrollment ^ICMJE

Completion Date

June 2001

Primary Completion Date

Eligibility Criteria ^ICMJE

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 ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Location Countries ^ICMJE

United States

Administrative Information

NCT ID ^ICMJE

NCT00000363

Responsible Party

Study ID Numbers ^ICMJE

NIDCD-1160, RO1 DC 02620-04

Study Sponsor ^ICMJE

National Institute on Deafness and Other Communication Disorders (NIDCD)

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair:

Dr. Tasnee Chonmaitree

Information Provided By

National Institute on Deafness and Other Communication Disorders (NIDCD)

Verification Date

April 2006

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP