Pilot Evaluation of CVT-E002 in Pediatric Upper Respirato... | NCT00255307

Studies
Pilot Evaluation of CVT-E002 in Pediatric Upper Respiratory Tract Infection.

NCT00255307

Sponsor

CV Technologies

Status

Completed

Last Update Posted

Jun 18, 2007Estimated

Enrollment

75Actual

Phase

Phase 2

Conditions

Upper Respiratory Infection

Interventions

CVT-E002 ginseng extract

Countries

Canada

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

Jun 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

Start Date

Nov 2005

Primary Completion Date

Not provided

Completion Date

Apr 2006Actual

First Submitted Date

Nov 16, 2005

First Submission Date that Met QC Criteria

Nov 16, 2005

First Posted Date

Nov 18, 2005Estimated

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

Jun 14, 2007

Last Update Posted Date

Jun 18, 2007Estimated

Name	Class
University of Alberta	OTHER
Capital Health, Canada	OTHER

Description Module

Brief Summary

This is a randomized double-blind three-arm trial to evaluate two dosages of CVT-E002 against placebo in pediatric upper respiratory tract infections (URTI). It is hypothesized that CVT-E002 use at standard doses reduces the duration of URTI in children aged 3-12 years.

Detailed Description

The eligible children, for whom parental consent has been obtained, will be randomized to one of three groups (standard dose, low dose, or placebo). The standard dose group will receive an oral aqueous solution using the standard dose of CVT-E002, adjusted according to the child's weight. The second group will receive an oral aqueous solution with half of the standard dose of CVT-E002, adjusted according to the child's weight, and the third group will receive a placebo as an aqueous solution of starch that does not contain any CVT-E002 or active medication, volume adjusted for the child's weight. Parents will be provided with a 3-day supply of study medication according to the randomization schedule. CVT-E002 will be administered by the parent to the child three times daily for three consecutive days following the onset of a URTI. Severity and duration of URTI will be measured using the reliable and valid Canadian Acute Respiratory Infection Flu Score (CARIFS).

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Name	Type	Description	Arm Group Labels	Other Names
CVT-E002 ginseng extract	Drug

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
To establish preliminary estimate of treatment effect of two doses of American ginseng extract, CVT-E002, in reducing severity and duration of URTI in children

Secondary Outcomes

Measure	Description	Time Frame
To document adverse events related to the short course of American ginseng extract, CVT-E002, in children

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children aged 3-12 years who present to their pediatrician with in 48 hours of the onset of an acute upper respiratory tract infection.
signed informed consent form

Exclusion Criteria:

Children who have had an immunization in 3 months prior to the study
Children with known hypoglycemia or diabetes
Children who have a bacterial illness diagnosed at the same visit (e.g. otitis media, pneumonia, etc.) which will be treated with antibiotic therapy
Children who have a malignancy or who have undergone treatment for a malignancy in the previous three months
Children with known active liver disease (e.g. hepatitis)
Known hypersensitivity to ginseng products
Concurrent treatment with warfarin, digoxin, ginseng products or phenelzine
Patients with coagulation disorders

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

3 Years

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
Sunita Vohra, MD	University of Alberta/Capital Health	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Stollery Children's Hospital		Edmonton	Alberta	T6G 2R7	Canada
Misericordia Child Health Clinic

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
18676527	Derived	Vohra S, Johnston BC, Laycock KL, Midodzi WK, Dhunnoo I, Harris E, Baydala L. Safety and tolerability of North American ginseng extract in the treatment of pediatric upper respiratory tract infection: a phase II randomized, controlled trial of 2 dosing schedules. Pediatrics. 2008 Aug;122(2):e402-10. doi: 10.1542/peds.2007-2186.

ID	Term
D012141	Respiratory Tract Infections
D003139	Common Cold
D007251	Influenza, Human

ID	Term
D007239	Infections
D012140	Respiratory Tract Diseases
D010850	Picornaviridae Infections
D012327	RNA Virus Infections