Echinaforce Junior Bioavailability Trial | NCT03070314

Studies
Echinaforce Junior Bioavailability Trial

NCT03070314

Sponsor

A. Vogel AG

Status

Withdrawn

Last Update Posted

Jul 18, 2018Actual

Enrollment

0Actual

Phase

Phase 4

Conditions

Common Cold

Interventions

Echinaforce junior

Countries

Switzerland

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

Jul 2018

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

no participants could be recruited who were eager to donate blood for bioavailability despite prolongation of the study period.

Expanded Access Info

Start Date

Feb 20, 2017Actual

Primary Completion Date

Jun 30, 2018Actual

Completion Date

Jun 30, 2018Actual

First Submitted Date

Feb 22, 2017

First Submission Date that Met QC Criteria

Feb 28, 2017

First Posted Date

Mar 3, 2017Actual

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

Jul 17, 2018

Last Update Posted Date

Jul 18, 2018Actual

Name	Class
University Children's Hospital, Zurich	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

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

In this bioavailability trial should be shown that the one of the main active constituent in alcoholic echinacea extracts, the alkylamide dodeca-2E,4E,8Z,10E/Z-tetraenoic acid isobutylamide (short: tetraen) is bioavailable in children of different age groups after intake of 5 Echinaforce junior tablets.

Detailed Description

Six capillary blood draws are taken at the following time points: Start (0), after 15, 30, 60, 90, 270 minutes and thereafter the bioavailability is measured and calculated.

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

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Echinaforce junior	Experimental	Echinaforce is an ethanolic extract from Echinacea purpurea fresh plant and root. The product is registered in Switzerland for children from age 4 years on for Treatment and prevention of respiratory tract infections.	Drug: Echinaforce junior

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Echinaforce junior	Drug	Echinacea Purpurea Extract Pill, sweetened and with orange flavour	Echinaforce junior

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Peak Plasma Concentration (Cmax)	Peak concentration of tetraen	270 minutes measurement

Secondary Outcomes

Measure	Description	Time Frame
Area under the plasma concentration versus time curve (AUC)	Area of tetraen in plasma versus time curve	270 minutes measurement
Timepoint when Cmax is reached (tmax)	timepoint when maximum tetraen concentration is reached

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Children in the age group 4-12 years with an uncomplicated common cold (upper respiratory tract infection)
First symptoms appeared within the last 72 hours
Written consent given by the parents and verbal consent of children who are capable of judgement

Exclusion Criteria:

Not able to fast 2 hours prior to the treatment
intake of another preparation containing echinacea within the last 24 hours
Participation in a clinical trial within the last 30 days
any progressive systemic illness, including tuberculosis, leukemia, connective tissue diseases, multiple sclerosis, or other autoimmune diseases; or
history of relevant allergy, including allergy to Compositae plants

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

4 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

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University Children's Hospital (UZH-UCH), Infectiology, University of Zurich		Zurich		8032	Switzerland

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003139	Common Cold

Ancestor Terms

ID	Term
D012141	Respiratory Tract Infections
D007239	Infections
D010850	Picornaviridae Infections
D012327	RNA Virus Infections

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Model Description

The study participants take 5 tablets Echinaforce junior at once one after another per os. registered in Switzerland for children from age of 4 -12 years Six capillary blood draws are taken at the following time points: Start (0), after 15, 30, 60, 90, 270 minutes and then analyzed on the amount of tetraen. Bioavailability parameters will thereafter be calculated.