Acute Otitis Media: Adjuvant Therapy to Improve Outcome

This study has been completed.
Information provided by:
National Institute on Deafness and Other Communication Disorders (NIDCD) Identifier:
First received: November 2, 1999
Last updated: April 21, 2006
Last verified: April 2006
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.

Condition Intervention Phase
Otitis Media
Drug: Antihistamine
Drug: Corticosteroid
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:

Further study details as provided by National Institute on Deafness and Other Communication Disorders (NIDCD):

Estimated Study Completion Date: June 2001

Ages Eligible for Study:   2 Months to 1 Year
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00000363

United States, Texas
Univ of Texas Med Branch Children's Hosp
Galveston, Texas, United States, 77550
Sponsors and Collaborators
National Institute on Deafness and Other Communication Disorders (NIDCD)
Study Chair: Dr. Tasnee Chonmaitree
  More Information

Publications: Identifier: NCT00000363     History of Changes
Other Study ID Numbers: NIDCD-1160, RO1 DC 02620-04
Study First Received: November 2, 1999
Last Updated: April 21, 2006
Health Authority: United States: Federal Government

Keywords provided by National Institute on Deafness and Other Communication Disorders (NIDCD):
Adrenal Cortex Hormones
Histamine H1 Antagonists
Otitis Media

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Histamine Antagonists
Histamine H1 Antagonists
Histamine Agents
Molecular Mechanisms of Pharmacological Action
Neurotransmitter Agents
Pharmacologic Actions
Physiological Effects of Drugs processed this record on November 25, 2015