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

NCT01244581 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 84

Last updated 2012-06-20

No results posted yet for this study

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.

Conditions

  • Otitis Media, Suppurative

Interventions

DRUG

Amoxicillin-clavulanate

Amoxicillin-clavulanate 40 mg/kg/day in two daily doses for 7 days

DRUG

Placebo

Placebo mixture in two daily doses for 7 days

Sponsors & Collaborators

  • University of Oulu

    lead OTHER

Principal Investigators

  • Matti Uhari, Professor · University of Oulu

  • Terhi Tapiainen, MD, PhD · University of Oulu

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Max Age
16 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
1999-09-30
Primary Completion
2012-06-30
Completion
2012-06-30

Countries

  • Finland

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01244581 on ClinicalTrials.gov