Acute Otitis Media: Adjuvant Therapy to Improve Outcome

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00000363

Enrollment

Unknown

Registered

1999-11-03

Start date

Unknown

Completion date

2001-06-30

Last updated

2006-04-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Otitis Media

Keywords

Antibiotics, Adrenal Cortex Hormones, Histamine H1 Antagonists, Infant, Otitis Media

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.

Interventions

DRUGAntihistamine

DRUGCorticosteroid

Study design

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Masking

DOUBLE

Eligibility

Sex/Gender

ALL

Age

2 Months to 1 Years

Healthy volunteers

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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026