NCT00000363

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.

Trial Health

80
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 2, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 3, 1999

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2001

Completed
Last Updated

April 24, 2006

Status Verified

April 1, 2006

First QC Date

November 2, 1999

Last Update Submit

April 21, 2006

Conditions

Otitis Media

Keywords

AntibioticsAdrenal Cortex HormonesHistamine H1 AntagonistsInfantOtitis Media

Interventions

AntihistamineDRUG
CorticosteroidDRUG

Eligibility Criteria

Age2 Months - 1 Year
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Univ of Texas Med Branch Children's Hosp

Galveston, Texas, 77550, United States

Location

Related Publications (2)

  • 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.

    PMID: 14517524BACKGROUND

  • 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.

    PMID: 12633920BACKGROUND

MeSH Terms

Conditions

Otitis Media

Interventions

Histamine AntagonistsAdrenal Cortex Hormones

Condition Hierarchy (Ancestors)

OtitisEar DiseasesOtorhinolaryngologic Diseases

Intervention Hierarchy (Ancestors)

Histamine AgentsNeurotransmitter AgentsMolecular Mechanisms of Pharmacological ActionPharmacologic ActionsChemical Actions and UsesPhysiological Effects of DrugsHormonesHormones, Hormone Substitutes, and Hormone Antagonists

Study Officials

  • Dr. Tasnee Chonmaitree

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

November 2, 1999

First Posted

November 3, 1999

Study Completion

June 1, 2001

Last Updated

April 24, 2006

Record last verified: 2006-04

Locations

US(1)