Japanese Study Evaluating the Effects of Telithromycin in Children With Acute Otitis Media
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| ClinicalTrials.gov Identifier: NCT00638534 |
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Recruitment Status
:
Completed
First Posted
: March 19, 2008
Last Update Posted
: October 2, 2009
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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 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 |
- Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings
- Clinical efficacy: tympanic signs
- Acceptability: compliance and willingness to take medication
- Pharmacokinetics: plasma concentrations of telithromycin
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| Ages Eligible for Study: | 6 Months to 16 Years (Child) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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.
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
| Japan | |
| Sanofi-Aventis | |
| Tokyo, Japan | |
| Study Director: | CSD | Sanofi |
| 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:
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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 |