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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

Page last updated: December 08, 2011

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