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

NCT ID: NCT01244581

Last Updated: 2012-06-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

1999-09-30

Study Completion Date

2012-06-30

Brief Summary

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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 Description

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Conditions

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Otitis Media, Suppurative

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Amoxicillin-clavulanate

Oral amoxicillin-clavulanate 40 mg/kg/day divided in two daily doses for 7 days

Group Type EXPERIMENTAL

Amoxicillin-clavulanate

Intervention Type DRUG

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

Placebo

Group Type PLACEBO_COMPARATOR

Amoxicillin-clavulanate

Intervention Type DRUG

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

Placebo

Intervention Type DRUG

Placebo mixture in two daily doses for 7 days

Interventions

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Amoxicillin-clavulanate

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

Intervention Type DRUG

Placebo

Placebo mixture in two daily doses for 7 days

Intervention Type DRUG

Other Intervention Names

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Clavurion

Eligibility Criteria

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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
Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of Oulu

OTHER

Sponsor Role lead

Responsible Party

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Terhi Tapiainen

M.D., Ph.D.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Matti Uhari, Professor

Role: STUDY_DIRECTOR

University of Oulu

Terhi Tapiainen, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Oulu

Locations

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Department of Pediatrics, Oulu University Hospital

Oulu, , Finland

Site Status

Lääkärikeskus Mehiläinen

Oulu, , Finland

Site Status

Countries

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Finland

References

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Tapiainen T, Kujala T, Renko M, Koivunen P, Kontiokari T, Kristo A, Pokka T, Alho OP, Uhari M. Effect of antimicrobial treatment of acute otitis media on the daily disappearance of middle ear effusion: a placebo-controlled trial. JAMA Pediatr. 2014 Jul;168(7):635-41. doi: 10.1001/jamapediatrics.2013.5311.

Reference Type DERIVED
PMID: 24797294 (View on PubMed)

Other Identifiers

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OYS_Tapiainen_001

Identifier Type: -

Identifier Source: org_study_id

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