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

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.
 
ClinicalTrials.gov Identifier: NCT00638534
Recruitment Status : Completed
First Posted : March 19, 2008
Last Update Posted : October 2, 2009
Sponsor:
Information provided by:
Sanofi

Study Description
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Brief 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.


Condition or disease Intervention/treatment Phase
Otitis Media Drug: Telithromycin (HMR3647) Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
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)
Study Start Date : February 2004
Actual Primary Completion Date : October 2004
Actual Study Completion Date : October 2004

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ear Infections

Arms and Interventions
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Outcome Measures
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Primary Outcome Measures :
  1. Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings

Secondary Outcome Measures :
  1. Clinical efficacy: tympanic signs
  2. Acceptability: compliance and willingness to take medication
  3. Pharmacokinetics: plasma concentrations of telithromycin

Eligibility Criteria
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Information from the National Library of Medicine

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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
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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
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Japan
Sanofi-Aventis
Tokyo, Japan
Sponsors and Collaborators
Sanofi
Investigators
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Study Director: CSD Sanofi
More Information
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Responsible Party: ICD Study Director, sanofi-aventis
ClinicalTrials.gov Identifier: NCT00638534     History of Changes
Other Study ID Numbers: EFC6370
HMR3647B/3103
First Posted: March 19, 2008    Key Record Dates
Last Update Posted: October 2, 2009
Last Verified: October 2009
Keywords provided by Sanofi:
Acute Otitis Media
AOM
children
Child
Additional relevant MeSH terms:
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Otitis
Otitis Media
Ear Diseases
Otorhinolaryngologic Diseases
 Telithromycin
Anti-Bacterial Agents
Anti-Infective Agents