Amoxicillin-clavulanate in Treating Acute Otitis Media Evaluated by Daily Tympanometry
NCT ID: NCT01244581
Last Updated: 2012-06-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE3
84 participants
INTERVENTIONAL
1999-09-30
2012-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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Amoxicillin-clavulanate
Oral amoxicillin-clavulanate 40 mg/kg/day divided in two daily doses for 7 days
Amoxicillin-clavulanate
Amoxicillin-clavulanate 40 mg/kg/day in two daily doses for 7 days
Placebo
Amoxicillin-clavulanate
Amoxicillin-clavulanate 40 mg/kg/day in two daily doses for 7 days
Placebo
Placebo mixture in two daily doses for 7 days
Interventions
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Amoxicillin-clavulanate
Amoxicillin-clavulanate 40 mg/kg/day in two daily doses for 7 days
Placebo
Placebo mixture in two daily doses for 7 days
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Tympanic membrane perforation
* Tympanostomy tubes (current)
* Complication of acute otitis media such as mastoiditis
16 Years
ALL
No
Sponsors
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University of Oulu
OTHER
Responsible Party
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Terhi Tapiainen
M.D., Ph.D.
Principal Investigators
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Matti Uhari, Professor
Role: STUDY_DIRECTOR
University of Oulu
Terhi Tapiainen, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Oulu
Locations
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Department of Pediatrics, Oulu University Hospital
Oulu, , Finland
Lääkärikeskus Mehiläinen
Oulu, , Finland
Countries
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References
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Tapiainen T, Kujala T, Renko M, Koivunen P, Kontiokari T, Kristo A, Pokka T, Alho OP, Uhari M. Effect of antimicrobial treatment of acute otitis media on the daily disappearance of middle ear effusion: a placebo-controlled trial. JAMA Pediatr. 2014 Jul;168(7):635-41. doi: 10.1001/jamapediatrics.2013.5311.
Other Identifiers
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OYS_Tapiainen_001
Identifier Type: -
Identifier Source: org_study_id
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