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

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ClinicalTrials.gov Identifier: NCT01244581
Recruitment Status : Completed
First Posted : November 19, 2010
Last Update Posted : June 20, 2012
Sponsor:
Information provided by (Responsible Party):
Terhi Tapiainen, University of Oulu

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

Study Type : Interventional  (Clinical Trial)
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 : September 1999
Actual Primary Completion Date : June 2012
Actual Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

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 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




Primary Outcome Measures :
  1. 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.


Secondary Outcome Measures :
  1. Time (days) to disappearance of pain [ Time Frame: Within 60 days ]


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Ages Eligible for Study:   up to 16 Years   (Child)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01244581


Locations
Finland
Department of Pediatrics, Oulu University Hospital
Oulu, Finland, 90014
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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
First Posted: November 19, 2010    Key Record Dates
Last Update Posted: June 20, 2012
Last Verified: June 2012

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

Additional relevant MeSH terms:
Otitis
Otitis Media
Otitis Media, Suppurative
Ear Diseases
Otorhinolaryngologic Diseases
Suppuration
Infection
Amoxicillin
Clavulanic Acid
Clavulanic Acids
Amoxicillin-Potassium Clavulanate Combination
Anti-Bacterial Agents
Anti-Infective Agents
beta-Lactamase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action