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Completed

NCT Number: NCT00638534

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

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.

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Key information

Conditions

Otitis Media Ear Diseases Otitis Otorhinolaryngologic Diseases

Age range

6 month–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Sanofi-Aventis

Tokyo, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Telithromycin (HMR3647)

Drug

Primary outcomes

  1. Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings

Secondary outcomes

  1. Clinical efficacy: tympanic signs

  2. Acceptability: compliance and willingness to take medication

  3. Pharmacokinetics: plasma concentrations of telithromycin

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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)

Important dates

Study start
2004
Primary completion
2004
Study completion
2004
First posted
Mar 19, 2008
Registry last updated
Oct 2, 2009

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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