Amoxicillin-clavulanate in Treating Acute Otitis Media Evaluated by Daily Tympanometry
Information source: University of Oulu
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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
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.
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
Eligibility
Minimum age: N/A.
Maximum age: 16 Years.
Gender(s): Both.
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
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
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