- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00000363
Acute Otitis Media: Adjuvant Therapy to Improve Outcome
April 21, 2006 updated by: National Institute on Deafness and Other Communication Disorders (NIDCD)
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Texas
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Galveston, Texas, United States, 77550
- Univ of Texas Med Branch Children's Hosp
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
2 months to 1 year (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Masking: Double
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Dr. Tasnee Chonmaitree
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Chonmaitree T, Saeed K, Uchida T, Heikkinen T, Baldwin CD, Freeman DH Jr, McCormick DP. A randomized, placebo-controlled trial of the effect of antihistamine or corticosteroid treatment in acute otitis media. J Pediatr. 2003 Sep;143(3):377-85. doi: 10.1067/S0022-3476(03)00293-2.
- McCormick DP, Saeed K, Uchida T, Baldwin CD, Deskin R, Lett-Brown MA, Heikkinen T, Chonmaitree T. Middle ear fluid histamine and leukotriene B4 in acute otitis media: effect of antihistamine or corticosteroid treatment. Int J Pediatr Otorhinolaryngol. 2003 Mar;67(3):221-30. doi: 10.1016/s0165-5876(02)00372-5.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Completion
June 1, 2001
Study Registration Dates
First Submitted
November 2, 1999
First Submitted That Met QC Criteria
November 2, 1999
First Posted (Estimate)
November 3, 1999
Study Record Updates
Last Update Posted (Estimate)
April 24, 2006
Last Update Submitted That Met QC Criteria
April 21, 2006
Last Verified
April 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- NIDCD-1160
- R01DC002620-04 (U.S. NIH Grant/Contract)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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