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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
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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

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Arms and Interventions
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Outcome Measures
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Eligibility Criteria
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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
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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
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Publications:

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ClinicalTrials.gov Identifier: NCT00000363     History of Changes
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