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Acute Otitis Media: Adjuvant Therapy to Improve Outcome



Acute Otitis Media: Adjuvant Therapy to Improve Outcome

For Condition: Otitis Media
Status: No longer recruiting
Sponsor(s): National Institute on Deafness and Other Communication Disorders (NIDCD) ,
Synopsis: 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.
Details:
Eligibility:
Study Type:
  Interventional, Treatment, Randomized, Double-Blind, Placebo Control, Efficacy Study
Minimum Age/Maximum Age: 2 Months/1 Year
Genders: Both
Protocol Entry Criteria: 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.
Total Enrollment: 

Location and Contact Information:

Overall Study Official:
Dr.Chonmaitree,  Study Chair, 

Univ of Texas Med Branch Children's Hosp
Galveston,  Texas,  77550
United States
 


Additional Information:
Study ID Numbers:
  NIDCD-1160;  RO1 DC 02620-04
Study Start Date: 
Record last reviewed: October 2003
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00000363

Other Otitis Media Studies:
1. Levofloxacin In The Treatment Of Children With Recurrent And/or Persistent Acute Otitis Media

2. Study of Levofloxacin to Evaluate Bacteriologic Outcome In Children with Difficult To Treat Acute Otitis Media

3. Acute Otitis Media: Adjuvant Therapy to Improve Outcome

4. Nervous System Manipulation and Botanicals for the Treatment of Recurrent Ear Infections in Children

Related Studies:

Other Otitis Media Clinical Trials
Other Texas Clinical Trials
Other Galveston Clinical Trials

Acute Otitis Media: Adjuvant Therapy to Improve Outcome

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