Back to resultsJapanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media
Primary Purpose
Otitis Media
Status
Completed
Phase
Phase 3
Locations
Japan
Study Type
Interventional
Intervention
Telithromycin (HMR3647)
Sponsored by
About this trial
This is an interventional treatment trial for Otitis Media focused on measuring Acute Otitis Media, AOM, children, Child
Eligibility Criteria
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.
Sites / Locations
- Sanofi-Aventis
Outcomes
Primary Outcome Measures
Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings
Secondary Outcome Measures
Clinical efficacy: tympanic signs
Acceptability: compliance and willingness to take medication
Pharmacokinetics: plasma concentrations of telithromycin
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00638534
Brief Title
Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media
Official Title
Evaluation of the Safety, Efficacy, Pharmacokinetics, and Acceptability of HMR3647 20 mg/kg qd for 5 Days With Acute Otitis Media (AOM) in Children (Multicenter, Open Label, Non Comparative Study)
Study Type
Interventional
2. Study Status
Record Verification Date
October 2009
Overall Recruitment Status
Completed
Study Start Date
February 2004 (undefined)
Primary Completion Date
October 2004 (Actual)
Study Completion Date
October 2004 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
Sanofi
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Otitis Media
Keywords
Acute Otitis Media, AOM, children, Child
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
56 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Telithromycin (HMR3647)
Primary Outcome Measure Information:
Title
Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings
Secondary Outcome Measure Information:
Title
Clinical efficacy: tympanic signs
Title
Acceptability: compliance and willingness to take medication
Title
Pharmacokinetics: plasma concentrations of telithromycin
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Months
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
CSD
Organizational Affiliation
Sanofi
Official's Role
Study Director
Facility Information:
Facility Name
Sanofi-Aventis
City
Tokyo
Country
Japan
12. IPD Sharing Statement
Learn more about this trial
Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media
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