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

Otitis Media, Suppurative Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01244581
• Other study ID #: OYS_Tapiainen_001
• Status: Completed
• Phase: Phase 3
• First received: November 18, 2010
• Last updated: June 19, 2012
• Start date: September 1999
• Est. completion date: June 2012

Study information

• Verified date: June 2012
• Source: University of Oulu
• Contact: n/a
• Is FDA regulated: No
• Health authority: Finland: Finnish Medicines Agency
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: June 2012
• Est. primary completion date: June 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A to 16 Years

Eligibility

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

Study Design

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

Related Conditions & MeSH terms

• Otitis
• Otitis Media
• Otitis Media, Suppurative

Intervention

Drug:
• 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

Locations

Country	Name	City	State
Finland	Department of Pediatrics, Oulu University Hospital	Oulu
Finland	Lääkärikeskus Mehiläinen	Oulu

Sponsors (1)

Lead Sponsor	Collaborator
University of Oulu

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Time (days) to disappearance of middle ear effusion	Disappearance of middle ear effusion is defined as the first day of receiving a normal tympanogram (A-curve) in tympanometry.	Within 60 days	No
Secondary	Time (days) to disappearance of pain		Within 60 days	No