Completed PHASE3 INTERVENTIONAL NCT00638534

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

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)

Sponsor: Sanofi

Conditions Otitis Media

Interventions Telithromycin (HMR3647)

Updated 5 times since 2017 Last updated: Oct 1, 2009 Started: Feb 29, 2004 Primary completion: Oct 31, 2004 Completion: Oct 31, 2004

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT00638534, this PHASE3 trial focuses on Otitis Media and remains completed. Sponsored by Sanofi, it has been updated 5 times since 2004, reflecting limited change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

Change History

5 versions recorded

Sep 2024 — Present [monthly]

Completed PHASE3
Jul 2024 — Sep 2024 [monthly]

Completed PHASE3
Jan 2021 — Jul 2024 [monthly]

Completed PHASE3
Jun 2018 — Jan 2021 [monthly]

Completed PHASE3
Jan 2017 — Jun 2018 [monthly]

Completed PHASE3

First recorded

Feb 2004

Trial started

Per CT.gov start date — pre-dates our first snapshot

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Sanofi

Data source: Sanofi

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

• Tokyo, Japan