Trials / Completed
CompletedNCT00000363
Acute Otitis Media: Adjuvant Therapy to Improve Outcome
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- —
- Sponsor
- National Institute on Deafness and Other Communication Disorders (NIDCD) · NIH
- Sex
- All
- Age
- 2 Months – 1 Year
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Antihistamine | |
| DRUG | Corticosteroid |
Timeline
- Completion
- 2001-06-01
- First posted
- 1999-11-03
- Last updated
- 2006-04-24
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT00000363. Inclusion in this directory is not an endorsement.