Amoxicillin-clavulanate in Treating Acute Otitis Media Evaluated by Daily Tympanometry

June 19, 2012 updated by: Terhi Tapiainen, University of Oulu

Oral Amoxicillin-clavulanate in Treating Acute Otitis Media in Children: Randomized Double-blind Placebo-controlled Study Including Daily Monitoring With Tympanometry

The purpose of the study is to assess the efficacy of amoxicillin-clavulanate in treating acute otitis media in children. The primary end point is time to disappearance of middle ear effusion which monitored by daily tympanometry performed by families and study physicians.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

84

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Finland
      • Oulu, Finland, 90014
        • Department of Pediatrics, Oulu University Hospital
      • Oulu, Finland, 90100
        • Lääkärikeskus Mehiläinen

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

No older than 16 years (Child)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children with acute otitis media

Exclusion Criteria:

  • Amoxicillin allergy
  • Tympanic membrane perforation
  • Tympanostomy tubes (current)
  • Complication of acute otitis media such as mastoiditis

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Amoxicillin-clavulanate
Amoxicillin-clavulanate 40 mg/kg/day in two daily doses for 7 days
Other Names:
  • Clavurion
Drug: Placebo
Placebo mixture in two daily doses for 7 days
Experimental: Amoxicillin-clavulanate
Oral amoxicillin-clavulanate 40 mg/kg/day divided in two daily doses for 7 days
Drug: Amoxicillin-clavulanate
Amoxicillin-clavulanate 40 mg/kg/day in two daily doses for 7 days
Other Names:
  • Clavurion

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time (days) to disappearance of middle ear effusion
Time Frame: Within 60 days
Disappearance of middle ear effusion is defined as the first day of receiving a normal tympanogram (A-curve) in tympanometry.
Within 60 days

Secondary Outcome Measures

Outcome Measure
Time Frame
Time (days) to disappearance of pain
Time Frame: Within 60 days
Within 60 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Oulu

Investigators

  • Principal Investigator: Terhi Tapiainen, MD, PhD, University of Oulu
  • Study Director: Matti Uhari, Professor, University of Oulu

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 1999

Primary Completion (Actual)

June 1, 2012

Study Completion (Actual)

June 1, 2012

Study Registration Dates

First Submitted

November 18, 2010

First Submitted That Met QC Criteria

November 18, 2010

First Posted (Estimate)

November 19, 2010

Study Record Updates

Last Update Posted (Estimate)

June 20, 2012

Last Update Submitted That Met QC Criteria

June 19, 2012

Last Verified

June 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • OYS_Tapiainen_001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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