Echinaforce Junior Bioavailability Trial

• ClinicalTrials.gov Identifier: NCT03070314
• Recruitment Status: Withdrawn
• First Posted: March 3, 2017
• Last Update Posted: July 18, 2018
• Sponsor: Bioforce AG
• Collaborator: University Children's Hospital, Zurich
• Information provided by (Responsible Party): Bioforce AG

Tracking Information

• First Submitted Date: February 22, 2017
• First Posted Date: March 3, 2017
• Last Update Posted Date: July 18, 2018
• Actual Study Start Date: February 20, 2017
• Actual Primary Completion Date: June 30, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: February 28, 2017)

Peak Plasma Concentration (Cmax) [ Time Frame: 270 minutes measurement ]

Peak concentration of tetraen

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: February 28, 2017)

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

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Echinaforce Junior Bioavailability Trial
• Official Title: Bioavailability of an Echinacea Product (Echinaforce® Junior) in Children With a Common Cold, Aged 4-12 Years After Intake of a Daily Dosage
• 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

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.

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.

• Study Type: Interventional
• Study Phase: Phase 4

Study Design

Allocation: N/A
Intervention Model: Single Group Assignment
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.

Masking: None (Open Label)
Primary Purpose: Basic Science

• Condition: Common Cold

Intervention

Drug: Echinaforce junior

Echinacea Purpurea Extract Pill, sweetened and with orange flavour

Study Arms

Experimental: Echinaforce junior

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.

Intervention: Drug: Echinaforce junior

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: July 17, 2018): 0
• Original Estimated Enrollment (submitted: February 28, 2017): 18
• Actual Study Completion Date: June 30, 2018
• Actual Primary Completion Date: June 30, 2018 (Final data collection date for primary outcome measure)

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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 4 Years to 12 Years (Child)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT03070314
• Other Study ID Numbers: 5000121
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Bioforce AG
• Study Sponsor: Bioforce AG
• Collaborators: University Children's Hospital, Zurich
• Investigators: Not Provided
• PRS Account: Bioforce AG
• Verification Date: July 2018