Amoxicillin-clavulanate in Treating Acute Otitis Media Evaluated by Daily Tympanometry
Information source: University of Oulu
Information obtained from ClinicalTrials.gov on December 08, 2011
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Otitis Media, Suppurative
Intervention: Amoxicillin-clavulanate (Drug); Placebo (Drug)
Phase: Phase 3
Status: Recruiting
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
Overall contact:
Tiia Kujala, MD, Phone: +358-40-5865489, Email: tiia.kujala@mehilainen.fi
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
Tiia Kujala, MD, Phone: +358-40-5865489, Email: tiia.kujala@mehilainen.fi
Lääkärikeskus Mehiläinen, Oulu 90100, Finland; Recruiting
Tiia Kujala, MD, Phone: +358-40-5865489, Email: tiia.kujala@mehilainen.fi
Tiia Kujala, MD, Principal Investigator
Aila Kristo, MD, PhD, Sub-Investigator
Department of Pediatrics, Oulu University Hospital, Oulu 90014, Finland; Recruiting
Terhi Tapiainen, MD, PhD, Phone: +358-8-315 5185, Email: terhi.tapiainen@oulu.fi
Terhi Tapiainen, MD, PhD, Principal Investigator
Additional Information
Starting date: September 1999
Last updated: November 18, 2010
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