Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media
Phase 3
Completed
- Conditions
- Otitis Media
- Registration Number
- NCT00638534
- Lead Sponsor
- Sanofi
- Brief Summary
The primary objective is to assess the safety of telithromycin (HMR3647) 20 mg/kg qd for 5 days in children with acute otitis media (AOM).
Secondary objectives are to assess Efficacy, Pharmacokinetics and Acceptability of telithromycin 20 mg/kg qd for 5 days in children with AOM.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 56
Inclusion Criteria
- Subjects who are weighing 40 kg or less. If female, premenarchal status is required.
- 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.
Exclusion Criteria
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings
- Secondary Outcome Measures
Name Time Method Clinical efficacy: tympanic signs Acceptability: compliance and willingness to take medication Pharmacokinetics: plasma concentrations of telithromycin
Trial Locations
- Locations (1)
Sanofi-Aventis
🇯🇵Tokyo, Japan