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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Terhi Tapiainen, University of Oulu
ClinicalTrials.gov Identifier:
NCT01244581
First received: November 18, 2010
Last updated: June 19, 2012
Last verified: June 2012
History of Changes
  Purpose

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 Intervention Phase
Otitis Media, Suppurative
 Drug: Amoxicillin-clavulanate
Drug: Placebo
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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

Resource links provided by NLM:

MedlinePlus related topics: Ear Infections
U.S. FDA Resources

Further study details as provided by University of Oulu:

Primary Outcome Measures:
  • Time (days) to disappearance of middle ear effusion [ Time Frame: Within 60 days ] [ Designated as safety issue: No ]
    Disappearance of middle ear effusion is defined as the first day of receiving a normal tympanogram (A-curve) in tympanometry.


Secondary Outcome Measures:
  • Time (days) to disappearance of pain [ Time Frame: Within 60 days ] [ Designated as safety issue: No ]

Enrollment: 84
Study Start Date: September 1999
Study Completion Date: June 2012
Primary Completion Date: June 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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 Name: Clavurion
Placebo Comparator: Placebo Drug: Amoxicillin-clavulanate
Amoxicillin-clavulanate 40 mg/kg/day in two daily doses for 7 days
Other Name: Clavurion
Drug: Placebo
Placebo mixture in two daily doses for 7 days

  Eligibility

Ages Eligible for Study:   up to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01244581

Locations
Finland
Lääkärikeskus Mehiläinen
Oulu, Finland, 90100
Department of Pediatrics, Oulu University Hospital
Oulu, Finland, 90014
Sponsors and Collaborators
University of Oulu
Investigators
Study Director: Matti Uhari, Professor University of Oulu
Principal Investigator: Terhi Tapiainen, MD, PhD University of Oulu
  More Information

No publications provided

Responsible Party: Terhi Tapiainen, M.D., Ph.D., University of Oulu
ClinicalTrials.gov Identifier: NCT01244581     History of Changes
Other Study ID Numbers: OYS_Tapiainen_001
Study First Received: November 18, 2010
Last Updated: June 19, 2012
Health Authority: Finland: Finnish Medicines Agency

Keywords provided by University of Oulu:
middle ear effusion
amoxicillin-clavulanate
tympanometry

Additional relevant MeSH terms:
Otitis
Otitis Media
Otitis Media, Suppurative
Suppuration
Ear Diseases
Otorhinolaryngologic Diseases
Infection
Inflammation
Pathologic Processes
Amoxicillin
 Amoxicillin-Potassium Clavulanate Combination
Clavulanic Acids
Clavulanic Acid
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on May 19, 2013