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Trial NCT00000363

Resource URI: http://static.linkedct.org/resource/trials/NCT00000363
linkedct:brief_title Acute Otitis Media: Adjuvant Therapy to Improve Outcome
linkedct:condition <http://static.linkedct.org/resource/condition/9421>
linkedct: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.
linkedct:download_date Information obtained from ClinicalTrials.gov on December 30, 2009
linkedct:eligibility_gender Both
linkedct:eligibility_healthy_volunteers No
linkedct:eligibility_maximum_age 1 Year
linkedct:eligibility_minimum_age 2 Months
linkedct:end_date June 2001
linkedct:enrollment 0 (xsd:int)
linkedct:firstreceived_date November 2, 1999
linkedct:id NCT00000363
rdfs:label Trial NCT00000363
linkedct:lastchanged_date April 21, 2006
linkedct:lead_sponsor_agency National Institute on Deafness and Other Communication Disorders (NIDCD)
linkedct:location <http://static.linkedct.org/resource/location/202937>
linkedct:nct_id NCT00000363
linkedct:number_of_arms 0 (xsd:int)
linkedct:number_of_groups 0 (xsd:int)
linkedct:org_study_id NIDCD-1160
linkedct:overall_official <http://static.linkedct.org/resource/overall_official/15031>
linkedct:overall_status Completed
linkedct:oversight <http://static.linkedct.org/resource/oversight/2918>
foaf:page <http://clinicaltrials.gov/show/NCT00000363>
linkedct:phase Phase 3
linkedct:reference <http://static.linkedct.org/resource/reference/16656>
linkedct:reference <http://static.linkedct.org/resource/reference/19415>
linkedct:secondary_id RO1 DC 02620-04
linkedct:source National Institute on Deafness and Other Communication Disorders (NIDCD)
linkedct:study_design Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
linkedct:study_type Interventional
linkedct: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.
rdf:type linkedct:trials
linkedct:verification_date April 2006