Acute Otitis Media: Adjuvant Therapy to Improve Outcome

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ClinicalTrials.gov Identifier: NCT00000363

Recruitment Status : Completed

First Posted : November 3, 1999

Last Update Posted : April 24, 2006

Sponsor:

Information provided by:

National Institute on Deafness and Other Communication Disorders (NIDCD)

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Otitis Media	Drug: Antihistamine Drug: Corticosteroid	Phase 3

Study Design

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Study Type :	Interventional (Clinical Trial)
Allocation:	Randomized
Masking:	Double
Primary Purpose:	Treatment
Study Completion Date :	June 2001

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Genetic and Rare Diseases Information Center resources: Acute Graft Versus Host Disease

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	2 Months to 1 Year (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000363

Locations

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United States, Texas
Univ of Texas Med Branch Children's Hosp
Galveston, Texas, United States, 77550

Sponsors and Collaborators

National Institute on Deafness and Other Communication Disorders (NIDCD)

Investigators

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Study Chair:	Dr. Tasnee Chonmaitree

More Information

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.

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.

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ClinicalTrials.gov Identifier:	NCT00000363
Other Study ID Numbers:	NIDCD-1160 R01DC002620-04 ( U.S. NIH Grant/Contract )
First Posted:	November 3, 1999 Key Record Dates
Last Update Posted:	April 24, 2006
Last Verified:	April 2006

Keywords provided by National Institute on Deafness and Other Communication Disorders (NIDCD):


Antibiotics Adrenal Cortex Hormones Histamine H1 Antagonists Infant Otitis Media

Additional relevant MeSH terms:

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Otitis Otitis Media Ear Diseases Otorhinolaryngologic Diseases Histamine Antagonists	Histamine H1 Antagonists Histamine Agents Neurotransmitter Agents Molecular Mechanisms of Pharmacological Action Physiological Effects of Drugs

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