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

This study has been completed.
Information provided by:
Sanofi Identifier:
First received: March 12, 2008
Last updated: October 1, 2009
Last verified: October 2009

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.

Condition Intervention Phase
Otitis Media Drug: Telithromycin (HMR3647) Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Sanofi:

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

Enrollment: 56
Study Start Date: February 2004
Study Completion Date: October 2004
Primary Completion Date: October 2004 (Final data collection date for primary outcome measure)

Ages Eligible for Study:   6 Months to 16 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

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Please refer to this study by its identifier: NCT00638534

Tokyo, Japan
Sponsors and Collaborators
Study Director: CSD Sanofi
  More Information

Responsible Party: ICD Study Director, sanofi-aventis Identifier: NCT00638534     History of Changes
Other Study ID Numbers: EFC6370
Study First Received: March 12, 2008
Last Updated: October 1, 2009

Keywords provided by Sanofi:
Acute Otitis Media

Additional relevant MeSH terms:
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Anti-Bacterial Agents
Anti-Infective Agents processed this record on June 22, 2017