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

This study has been completed.

Sponsor:

Information provided by:

Sanofi

ClinicalTrials.gov Identifier:

NCT00638534

First received: March 12, 2008

Last updated: October 1, 2009

Last verified: October 2009

History of Changes

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 Endpoint Classification: Safety/Efficacy Study 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:

MedlinePlus related topics: Ear Infections

Drug Information available for: Telithromycin

Genetic and Rare Diseases Information Center resources: Children's Interstitial Lung Disease

U.S. FDA Resources

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


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

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, see Learn About Clinical Studies.

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

Locations


Japan
Sanofi-Aventis
Tokyo, Japan

Sponsors and Collaborators

Sanofi

Investigators


Study Director:	CSD	Sanofi

More Information

No publications provided


Responsible Party:	ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier:	NCT00638534 History of Changes
Other Study ID Numbers:	EFC6370, HMR3647B/3103
Study First Received:	March 12, 2008
Last Updated:	October 1, 2009
Health Authority:	Japan: Ministry of Health, Labor and Welfare

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 Pharmacologic Actions Therapeutic Uses

ClinicalTrials.gov processed this record on February 27, 2015

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