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

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

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

Brief 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.

Detailed Summary:
Sponsor: University of Oulu

Current Primary Outcome: Time (days) to disappearance of middle ear effusion [ Time Frame: Within 60 days ]

Disappearance of middle ear effusion is defined as the first day of receiving a normal tympanogram (A-curve) in tympanometry.


Original Primary Outcome: 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.


Current Secondary Outcome: Time (days) to disappearance of pain [ Time Frame: Within 60 days ]

Original Secondary Outcome: Time (days) to disappearance of pain

Information By: University of Oulu

Dates:
Date Received: November 18, 2010
Date Started: September 1999
Date Completion:
Last Updated: June 19, 2012
Last Verified: June 2012