Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media

Otitis Media Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00638534
• Other study ID #: EFC6370
• Secondary ID: HMR3647B/3103
• Status: Completed
• Phase: Phase 3
• First received: March 12, 2008
• Last updated: October 1, 2009
• Start date: February 2004
• Est. completion date: October 2004

Study information

• Verified date: October 2009
• Source: Sanofi
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 56
• Est. completion date: October 2004
• Est. primary completion date: October 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Months to 16 Years

Eligibility

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.

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Otitis
• Otitis Media

Intervention

Drug:
• Telithromycin (HMR3647)

Locations

Country	Name	City	State
Japan	Sanofi-Aventis	Tokyo

Sponsors (1)

Lead Sponsor	Collaborator
Sanofi

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings
Secondary	Clinical efficacy: tympanic signs
Secondary	Acceptability: compliance and willingness to take medication
Secondary	Pharmacokinetics: plasma concentrations of telithromycin