Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media
NCT ID: NCT00638534
Last Updated: 2009-10-02
Study Results
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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COMPLETED
PHASE3
56 participants
INTERVENTIONAL
2004-02-29
2004-10-31
Brief Summary
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Secondary objectives are to assess Efficacy, Pharmacokinetics and Acceptability of telithromycin 20 mg/kg qd for 5 days in children with AOM.
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Interventions
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Telithromycin (HMR3647)
Eligibility Criteria
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Inclusion Criteria
* Subjects with signs of infection according to middle ear signs and general signs or symptoms such as otalgia, fever, sleep disturbance, irritability, inconsolability.
The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
6 Months
16 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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sanofi-aventis
Principal Investigators
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CSD
Role: STUDY_DIRECTOR
Sanofi
Locations
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Sanofi-Aventis
Tokyo, , Japan
Countries
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Other Identifiers
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HMR3647B/3103
Identifier Type: -
Identifier Source: secondary_id
EFC6370
Identifier Type: -
Identifier Source: org_study_id
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