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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 February 2015 |
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Main ID: |
NCT01244581 |
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Date of registration:
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18/11/2010 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Amoxicillin-clavulanate in Treating Acute Otitis Media Evaluated by Daily Tympanometry
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Scientific title:
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Oral Amoxicillin-clavulanate in Treating Acute Otitis Media in Children: Randomized Double-blind Placebo-controlled Study Including Daily Monitoring With Tympanometry |
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Date of first enrolment:
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September 1999 |
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Target sample size:
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84 |
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Recruitment status: |
Completed |
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URL:
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http://clinicaltrials.gov/show/NCT01244581 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
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Phase:
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Phase 3
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Countries of recruitment
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Finland
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Contacts
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Name:
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Matti Uhari, Professor |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Oulu |
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Name:
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Terhi Tapiainen, MD, PhD |
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Address:
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Telephone:
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Email:
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Affiliation:
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University of Oulu |
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Key inclusion & exclusion 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
Age minimum:
N/A
Age maximum:
16 Years
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Otitis Media, Suppurative
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Intervention(s)
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Drug: Amoxicillin-clavulanate
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Drug: Placebo
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Primary Outcome(s)
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Time (days) to disappearance of middle ear effusion
[Time Frame: Within 60 days]
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Secondary Outcome(s)
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Time (days) to disappearance of pain
[Time Frame: Within 60 days]
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Secondary ID(s)
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OYS_Tapiainen_001
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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