Japanese Study Evaluating Safety, Efficacy and Acceptabil... | NCT00408135

Studies
Japanese Study Evaluating Safety, Efficacy and Acceptability of Telithromycin in Children With Infections

NCT00408135

Sponsor

Sanofi

Status

Completed

Last Update Posted

Apr 3, 2009Estimated

Enrollment

111Actual

Phase

Phase 3

Conditions

Infections
Child

Interventions

telithromycin (HMR3647)

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
HMR3647B/3104

Status Module

Record Verification Date

Apr 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Aug 2004

Primary Completion Date

May 2005Actual

Completion Date

May 2005Actual

First Submitted Date

Dec 5, 2006

First Submission Date that Met QC Criteria

Dec 5, 2006

First Posted Date

Dec 6, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 2, 2009

Last Update Posted Date

Apr 3, 2009Estimated

Description Module

Brief Summary

The primary objective is to assess the safety of telithromycin (HMR 3647) (20% fine granules) 1g filling sachet in children with infections (Respiratory tract infections, Dermatological infections, Otorhinolaryngological infections, Dentistry/Oral surgery infections).

Secondary objectives are to assess the clinical efficacy, bacteriological efficacy and acceptability of telithromycin (20% fine granules) 1g filling sachet in children with infections.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

111Actual

Name	Type	Description	Arm Group Labels	Other Names
telithromycin (HMR3647)	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Safety evaluation: presence/absence of subjective/objective symptoms and abnormal laboratory findings (abnormal changes of parameters in general hematological tests and blood biochemical tests).

Secondary Outcomes

Measure	Description	Time Frame
Clinical efficacy:change in the symptoms and signs at end of therapy visit and at the test of cure visit

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Outpatients of weight from 7.0 kg.
For respiratory tract infections:subjects diagnosed with mild or moderate respiratory tract infection (excluding pneumonia) based on a fever (≥ 38°C) or C-Reactive Protein positive, clinical symptoms/signs, and laboratory findings.
For dermatological infections: subjects diagnosed with mild or moderate dermatological infection in terms of clinical symptoms/signs and laboratory findings.
For otorhinolaryngological infections:subjects with purulent / mucopurulent rhinorrhea and postrhinorrhea, subjects diagnosed with mild or moderate otorhinolaryngological infection in terms of clinical symptoms/signs and laboratory findings
For dental / oral surgical infections: subjects who have formed obstructive abscess and diagnosed with mild or moderate dental / oral surgical infection

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

6 Months

Maximum Age

16 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Norifumi Yamamoto	sanofi-aventis Japan	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Sanofi-Aventis		Tokyo			Japan

Condition Browse Module

MeSH Terms

ID	Term
D007239	Infections
D012141	Respiratory Tract Infections
D012871	Skin Diseases
D012852	Sinusitis

Ancestor Terms

ID	Term
D012140	Respiratory Tract Diseases
D017437	Skin and Connective Tissue Diseases
D010254	Paranasal Sinus Diseases
D009668	Nose Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C106791	telithromycin

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided