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

This study has been completed.

First Received: March 12, 2008 Last Updated: March 30, 2009 History of Changes

Sponsored by:	Sanofi-Aventis
Information provided by:	Sanofi-Aventis
ClinicalTrials.gov Identifier:	NCT00638534

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 III

Study Type:	Interventional
Study Design:	Treatment, Non-Randomized, Open Label, Uncontrolled, Single Group Assignment, Safety/Efficacy Study
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:

MedlinePlus related topics: Ear Infections

Drug Information available for: Telithromycin

U.S. FDA Resources

Further study details as provided by Sanofi-Aventis:

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
Primary Completion Date:	October 2004 (Final data collection date for primary outcome measure)

Eligibility

Ages Eligible for Study:	6 Months to 16 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00638534

Locations

Japan
Sanofi-Aventis
Tokyo, Japan

Sponsors and Collaborators

Sanofi-Aventis

Investigators

Study Director:

CSD

Sanofi-Aventis

More Information

Additional Information:

Related Info This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party:	sanofi-aventis ( ICD Study Director )
Study ID Numbers:	EFC6370, HMR3647B/3103
Study First Received:	March 12, 2008
Last Updated:	March 30, 2009
ClinicalTrials.gov Identifier:	NCT00638534 History of Changes
Health Authority:	Japan: Ministry of Health, Labor and Welfare

Keywords provided by Sanofi-Aventis:

Acute Otitis Media
AOM
children
Child

Study placed in the following topic categories:

Anti-Infective Agents
Anti-Bacterial Agents
Otorhinolaryngologic Diseases
Otitis

Otitis Media
Ear Diseases
Telithromycin

Additional relevant MeSH terms:

Anti-Infective Agents
Anti-Bacterial Agents
Otorhinolaryngologic Diseases
Therapeutic Uses
Otitis

Otitis Media
Ear Diseases
Pharmacologic Actions
Telithromycin

ClinicalTrials.gov processed this record on September 10, 2009