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

Sponsor
University of Oulu (Other)
Overall Status
Completed
CT.gov ID
NCT01244581
Collaborator
(none)
84
Enrollment
2
Locations
2
Arms
153
Duration (Months)
42
Patients Per Site
0.3
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
Phase 3

Study Design

Study Type:
Interventional
Actual Enrollment :
84 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Oral Amoxicillin-clavulanate in Treating Acute Otitis Media in Children: Randomized Double-blind Placebo-controlled Study Including Daily Monitoring With Tympanometry
Study Start Date :
Sep 1, 1999
Actual Primary Completion Date :
Jun 1, 2012
Actual Study Completion Date :
Jun 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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

    		•
    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

    Outcome Measures

    Primary Outcome Measures

    1. Time (days) to disappearance of middle ear effusion [Within 60 days]

      Disappearance of middle ear effusion is defined as the first day of receiving a normal tympanogram (A-curve) in tympanometry.

    Secondary Outcome Measures

    1. Time (days) to disappearance of pain [Within 60 days]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    N/A to 16 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Pediatrics, Oulu University Hospital Oulu Finland 90014
    2 Lääkärikeskus Mehiläinen Oulu Finland 90100

    Sponsors and Collaborators

    • University of Oulu

    Investigators

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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Terhi Tapiainen, M.D., Ph.D., University of Oulu
    ClinicalTrials.gov Identifier:
    NCT01244581
    Other Study ID Numbers:
    • OYS_Tapiainen_001
    First Posted:
    Nov 19, 2010
    Last Update Posted:
    Jun 20, 2012
    Last Verified:
    Jun 1, 2012
    Keywords provided by Terhi Tapiainen, M.D., Ph.D., University of Oulu
    middle ear effusion
    amoxicillin-clavulanate
    tympanometry
    Additional relevant MeSH terms:
    Otitis Media, Suppurative
    Otitis
    Otitis Media
    Amoxicillin
    Clavulanic Acid
    Clavulanic Acids
    Amoxicillin-Potassium Clavulanate Combination

    Study Results

    No Results Posted as of Jun 20, 2012