Back to resultsAcute Otitis Media: Adjuvant Therapy to Improve Outcome
Primary Purpose
Otitis Media
Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Antihistamine
Corticosteroid
Sponsored by
About this trial
This is an interventional treatment trial for Otitis Media focused on measuring Antibiotics, Adrenal Cortex Hormones, Histamine H1 Antagonists, Infant, Otitis Media
Eligibility 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.
Sites / Locations
- Univ of Texas Med Branch Children's Hosp
Outcomes
Primary Outcome Measures
Secondary Outcome Measures
Full Information
NCT ID
NCT00000363
First Posted
November 2, 1999
Last Updated
April 21, 2006
Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
1. Study Identification
Unique Protocol Identification Number
NCT00000363
Brief Title
Acute Otitis Media: Adjuvant Therapy to Improve Outcome
Study Type
Interventional
2. Study Status
Record Verification Date
April 2006
Overall Recruitment Status
Completed
Study Start Date
undefined (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
June 2001 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
4. Oversight
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media
Keywords
Antibiotics, Adrenal Cortex Hormones, Histamine H1 Antagonists, Infant, Otitis Media
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Masking
Double
Allocation
Randomized
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Antihistamine
Intervention Type
Drug
Intervention Name(s)
Corticosteroid
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Months
Maximum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dr. Tasnee Chonmaitree
Official's Role
Study Chair
Facility Information:
Facility Name
Univ of Texas Med Branch Children's Hosp
City
Galveston
State/Province
Texas
ZIP/Postal Code
77550
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
14517524
Citation
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.
Results Reference
background
PubMed Identifier
12633920
Citation
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.
Results Reference
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Acute Otitis Media: Adjuvant Therapy to Improve Outcome
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