A randomized, placebo-controlled trial of the effect of antihistamine or corticosteroid treatment in acute otitis media.
Tasnee Chonmaitree, Kokab Saeed, Tatsuo Uchida...
https://pubmed.ncbi.nlm.nih.gov/14517524Completed
Phase 3
Age: 2Months - 1Year
All Genders
ID00000363
Led by National Institute on Deafness and Other Communication Disorders (NIDCD) · Updated on 2006-04-24
N/A
Participants Needed
1
Research Sites
N/A
Total Duration
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AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Acute Otitis Media: Adjuvant Therapy to Improve Outcome
Who Can Participate
Age: 2Months - 1Year
All Genders
Eligibility Criteria
You may qualify if you...
- Have had two documented prior episodes of acute otitis media.
- Have no current middle ear effusion (fluid).
You will not qualify if you...
- Have chronic otitis media.
- Have acute otitis media in addition to chronic otitis media.
Trial Site Locations
Total: 1 location
1
Univ of Texas Med Branch Children's Hosp
Galveston, Texas, United States, 77550
Status Unknown
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How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
N/A
Primary Purpose
TREATMENT
Number of Arms
0
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Published Research Related To This Trial
Middle ear fluid histamine and leukotriene B4 in acute otitis media: effect of antihistamine or corticosteroid treatment.
David P McCormick, Kokab Saeed, Tatsuo Uchida...
https://pubmed.ncbi.nlm.nih.gov/12633920