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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00638534
First Posted: March 19, 2008
Last Update Posted: October 2, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Sanofi
  Purpose

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: None (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)
  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00638534


Locations
Japan
Sanofi-Aventis
Tokyo, Japan
Sponsors and Collaborators
Sanofi
Investigators
Study Director: CSD Sanofi
  More Information

Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00638534     History of Changes
Other Study ID Numbers: EFC6370
HMR3647B/3103
First Submitted: March 12, 2008
First Posted: March 19, 2008
Last Update Posted: October 2, 2009
Last Verified: October 2009

Keywords provided by Sanofi:
Acute Otitis Media
AOM
children
Child

Additional relevant MeSH terms:
Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
Telithromycin
Anti-Bacterial Agents
Anti-Infective Agents