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NCT00000363 Clinical Trial

Acute Otitis Media: Adjuvant Therapy to Improve Outcome

Otitis Media Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00000363
Other study ID # NIDCD-1160
Secondary ID RO1 DC 02620-04
Status Completed
Phase Phase 3
First received November 2, 1999
Last updated April 21, 2006
Est. completion date June 2001

Study information
Verified date April 2006
Source National Institute on Deafness and Other Communication Disorders (NIDCD)
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 0
Est. completion date June 2001
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 2 Months to 1 Year
Eligibility 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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Masking: Double-Blind, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Antihistamine

• Corticosteroid

Locations
Country Name City State
United States Univ of Texas Med Branch Children's Hosp Galveston Texas

Sponsors (1)
Lead Sponsor Collaborator
National Institute on Deafness and Other Communication Disorders (NIDCD)

Country where clinical trial is conducted

United States, 

References & 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. — View 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. — View Citation

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