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

Information source: University of Oulu
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Otitis Media, Suppurative

Intervention: Amoxicillin-clavulanate (Drug); Placebo (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: University of Oulu

Official(s) and/or principal investigator(s):
Matti Uhari, Professor, Study Director, Affiliation: University of Oulu
Terhi Tapiainen, MD, PhD, Principal Investigator, Affiliation: University of Oulu


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.

Clinical Details

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

Study design: Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Primary outcome: Time (days) to disappearance of middle ear effusion

Secondary outcome: Time (days) to disappearance of pain


Minimum age: N/A. Maximum age: 16 Years. Gender(s): Both.


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

Locations and Contacts

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

Lääkärikeskus Mehiläinen, Oulu 90100, Finland

Additional Information

Starting date: September 1999
Last updated: June 19, 2012

Page last updated: August 23, 2015

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