Study of Cefditoren Pivoxil in Treatment of Childhood Wit... | NCT01553006

Studies
Study of Cefditoren Pivoxil in Treatment of Childhood With Acute Rhinosinusitis

NCT01553006

Sponsor

Thammasat University

Status

Unknown status

Last Update Posted

Mar 14, 2012Estimated

Enrollment

120Estimated

Phase

Phase 4

Conditions

Rhinosinusitis

Interventions

cefditoren pivoxil

Countries

Thailand

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

Status Module

Record Verification Date

Mar 2012

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2012

Primary Completion Date

Aug 2012Estimated

Completion Date

Sep 2012Estimated

First Submitted Date

Feb 17, 2012

First Submission Date that Met QC Criteria

Mar 12, 2012

First Posted Date

Mar 13, 2012Estimated

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

Mar 13, 2012

Last Update Posted Date

Mar 14, 2012Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Cefditoren pivoxil has been used in rhinosinusitis treatment. However, little is known about the efficacy of this drug at low and high doses.

Detailed Description

The investigation was a randomized, investigator-blinded, and parallel study, conducted in patients (age 1-15 years) with acute rhinosinusitis. Two groups of patients were randomized received low (10 MKD) or high (20 MKD) of drug for 14 days. Changes in sinus symptoms scores, response rate and adverse effect were evaluated at days 7 and 14. Relapse rate was recorded at days 21 and 28. Recurrence of sinus symptoms at day 60 were assessed.

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 4

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
cefditoren pivoxil	Active Comparator	cefditoren 10 mg/kg/day for 14 days	Drug: cefditoren pivoxil
cefditoren pivoxil high dose	Active Comparator	cefditoren 20 MKD were used to compare efficacy of treatment.	Drug: cefditoren pivoxil

Interventions

Name	Type	Description	Arm Group Labels	Other Names
cefditoren pivoxil	Drug	comparison of different dosages of cefditoren pivoxil	cefditoren pivoxil cefditoren pivoxil high dose

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
sinus symptoms scores	Change of sinus sympotms scores from baseline in 2 weeks	14 days

Secondary Outcomes

Measure	Description	Time Frame
relapse rate	The relapse rate of sinus symptoms scores at day 28.	at day 28

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

children age 1-15 years old diagnosed acute rhinosinusitis

Exclusion Criteria:

poor compliance
other infections

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

15 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Orapan Poachanukoon, MD.	Thammasat University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Thammasat University	Recruiting	Prathumthani		12120	Thailand

Condition Browse Module

MeSH Terms

ID	Term
D000096825	Rhinosinusitis

Ancestor Terms

ID	Term
D012220	Rhinitis
D012141	Respiratory Tract Infections
D007239	Infections
D012852	Sinusitis

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C057710	cefditoren pivoxil

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided