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

• Status: Completed
• Trial end date: 2004-10-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Sanofi
• Treatments: Telithromycin

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.