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

NCT00000363 is a Phase 3 study that has completed, run by National Institute on Deafness and Other Communication Disorders (NIDCD). According to ClinicalTrials.gov, the official US trial registry.

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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 finished NCT00000363 record still lists

NCT00000363 is an interventional study that assigns participants to a tested intervention. An enrollment target was not published in the registry record, which is common for early-stage or observational entries.

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

NCT00000363 does not publish any study locations in the registry export this page uses.

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.

Source: ClinicalTrials.gov NCT00000363, the US trial registry maintained by the National Library of Medicine. NCT00000363 (unsized enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.