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CompletedNCT00000363Updated Apr 24, 2006

Acute Otitis Media: Adjuvant Therapy to Improve Outcome

A Phase 3 interventional study of Antihistamine and Corticosteroid in Otitis Media, sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD). Completed at 1 site in United States. Open to participants aged 2 Months to 1 Year. Per ClinicalTrials.gov, last updated 2006-04-24.

Sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD) · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Allocation
Randomized
Ages
2 Months to 1 Year
Sex
All
01

Study 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.

02

Conditions studied

  • Otitis Media

Keywords

  • Antibiotics
  • Adrenal Cortex Hormones
  • Histamine H1 Antagonists
  • Infant
  • Otitis Media
03

In context

Otitis

246 studies on the registry are indexed under Otitis; 21 are open to participants now.

Browse Otitis studies →

Lead sponsor

National Institute on Deafness and Other Communication Disorders (NIDCD) is the lead sponsor of 37 studies on the registry; 7 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
2 Months to 1 Year
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Have had two documented prior episodes of acute otitis media.
  • Have no current middle ear effusion (fluid).

Exclusion criteria

Exclusion Criteria:

  • Have chronic otitis media.
  • Have acute otitis media in addition to chronic otitis media.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Masking
Double

Interventions

  • DrugAntihistamine
  • DrugCorticosteroid
06

Study locations

1 site
  • Univ of Texas Med Branch Children's Hosp
    Galveston, Texas 77550, United States
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References and documents

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. PubMed 14517524 ↗
  • 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. PubMed 12633920 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 24, 2006, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00000363
Lead sponsor
National Institute on Deafness and Other Communication Disorders (NIDCD)
First posted
Nov 3, 1999
Completion
Jun 2001
Last update
Apr 24, 2006

Study contacts

Dr. Tasnee Chonmaitree
study chair
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2006. You cannot join it, but the record below documents what was studied.

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