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NCT00000363 · ClinicalTrials.gov registry record · Phase 3

Acute Otitis Media: Adjuvant Therapy to Improve Outcome

A Phase 3 study, sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD).

Completed
Registry status
Phase 3
Development phase

NCT00000363 is a Phase 3 study that has completed, run by National Institute on Deafness and Other Communication Disorders (NIDCD).

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The verdict

NCT00000363, a Phase 3 study, has completed, sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD).

COMPLETED
Registry status
Phase 3
Development phase

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.

Interventions

  • DRUG Corticosteroid
  • DRUG Antihistamine

Trial Details

FieldValue
Est. Completion 2001-06
Phase Phase 3

What the Registry Record Tells You About NCT00000363

The ClinicalTrials.gov registry entry for NCT00000363 describes a study currently listed as completed, categorized as Phase 3. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is National Institute on Deafness and Other Communication Disorders (NIDCD), which has 34 total studies on file at ClinicalTrials.gov.

The record links to 0 conditions, and to 2 interventions - of which Corticosteroid is the first listed.

NCT00000363 reports 0 study locations.

Frequently Asked Questions

What is clinical trial NCT00000363 about?

NCT00000363 is a clinical study titled "Acute Otitis Media: Adjuvant Therapy to Improve Outcome". 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 st...

What is the current status of trial NCT00000363?

This trial is currently completed. It is a Phase 3 study. Estimated completion is 2001-06.

What interventions are being tested in trial NCT00000363?

The interventions under investigation include: Corticosteroid (DRUG), Antihistamine (DRUG).

Who is sponsoring clinical trial NCT00000363?

This trial is sponsored by National Institute on Deafness and Other Communication Disorders (NIDCD), which has 34 total clinical trials registered on ClinicalTrials.gov.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.