Famciclovir Oral Pediatric Formulation in Children 1-12 Y... | NCT00098046

Studies
Famciclovir Oral Pediatric Formulation in Children 1-12 Years of Age With Varicella Zoster Infection

NCT00098046

Sponsor

Novartis

Status

Completed

Last Update Posted

Sep 26, 2007Estimated

Enrollment

76Estimated

Phase

Phase 3

Conditions

Chickenpox
Herpes Zoster

Interventions

famciclovir

Countries

United States
Costa Rica
Guatemala
Panama

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

Sep 2007

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Not provided

Start Date

Jul 2005

Primary Completion Date

Not provided

Completion Date

Jul 2007Actual

First Submitted Date

Dec 2, 2004

First Submission Date that Met QC Criteria

Dec 2, 2004

First Posted Date

Dec 3, 2004Estimated

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

Sep 25, 2007

Last Update Posted Date

Sep 26, 2007Estimated

Description Module

Brief Summary

Varicella zoster virus causes chickenpox in children and shingles in adults. Chickenpox is usually a self-limiting illness characterized by fever and a rash. Serious complications can include secondary bacterial infections, pneumonia, and encephalitis. Anti-viral treatment is not a standard of care in immunocompetent children, but is recommended whenever a risk of complication exists. This study will evaluate the safety and blood levels of a new formulation of famciclovir in children 1-12 years of age.

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

76Estimated

Name	Type	Description	Arm Group Labels	Other Names
famciclovir	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Step A: Single-dose safety and pharmacokinetics
Step B: Safety and tolerability of pediatric formulation administered 3 times daily over 7 days

Secondary Outcomes

Measure	Description	Time Frame
Steps A & B: Acceptability of pediatric formulation by patients

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Male or female children 1-12 years of age
Clinical or laboratory evidence of varicella zoster infection
Patients suspected of having varicella zoster infection

Exclusion Criteria:

Patients unable to swallow
Concomitant use of probenecid
Positive pregnancy

Additional protocol-defined inclusion/exclusion criterial may apply. For detailed information on eligibility, please contact the study center nearest to you (see below), or call the following number 1-862-778-3544 or 1-434-951-3228

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

1 Year

Maximum Age

12 Years

Standard Ages

Child

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Novartis Pharmaceuticals	Novartis Pharmaceuticals	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Columbia University Medical Center		New York	New York	10032	United States
Novartis Investigational Site

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
19273678	Derived	Saez-Llorens X, Yogev R, Arguedas A, Rodriguez A, Spigarelli MG, De Leon Castrejon T, Bomgaars L, Roberts M, Abrams B, Zhou W, Looby M, Kaiser G, Hamed K. Pharmacokinetics and safety of famciclovir in children with herpes simplex or varicella-zoster virus infection. Antimicrob Agents Chemother. 2009 May;53(5):1912-20. doi: 10.1128/AAC.01054-08. Epub 2009 Mar 9.

ID	Term
D000073618	Varicella Zoster Virus Infection
D006566	Herpesviridae Infections
D004266	DNA Virus Infections
D014777	Virus Diseases

ID	Term
D000225	Adenine
D011687	Purines
D006574	Heterocyclic Compounds, 2-Ring
D000072471	Heterocyclic Compounds, Fused-Ring

ID	Term
D002644	Chickenpox
D006562	Herpes Zoster