Common ColdPhase 4NCT03070314
Echinaforce Junior Bioavailability Trial
A Phase 4 study testing Echinaforce junior in people with Common Cold, run by A. Vogel AG at 1 site in Switzerland.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 12 years
- Conditions the study is for
- Common Cold
- What is being tested?
- Echinaforce junior
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteSwitzerland
- Study dates
- 20 Feb 2017to 30 Jun 2018
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 12 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Children's Hospital (UZH-UCH), Infectiology, University of Zurich
Zurich, 8032
About this study
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
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.
Read the 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.
- Conditions
- Common Cold
- Being tested
- Echinaforce junior
- Keywords
- Echinacea, bioavailability, children
- Medical subject headings
- Common Cold
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Echinaforce juniorDrug
Echinacea Purpurea Extract Pill, sweetened and with orange flavour
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Echinaforce junior |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak Plasma Concentration (Cmax)
Peak concentration of tetraen
Measured: 270 minutes measurement
Secondary outcomes (2)
Area under the plasma concentration versus time curve (AUC)
Area of tetraen in plasma versus time curve
Measured: 270 minutes measurement
Timepoint when Cmax is reached (tmax)
timepoint when maximum tetraen concentration is reached
Measured: 270 minutes measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2017
- Study start20 Feb 2017
- Primary completion30 Jun 2018
- Study completion30 Jun 2018
Why it stopped: no participants could be recruited who were eager to donate blood for bioavailability despite prolongation of the study period.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Common ColdStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- 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)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- A. Vogel AG
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- University Children's Hospital, Zurich
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03070314
- Sponsor's protocol ID
- 5000121
- Status last verified
- Jul 2018
- First submitted
- 22 Feb 2017
- Last updated
- 18 Jul 2018
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03070314
- Acronym / sponsor ID
- 5000121
- Conditions
- Common Cold
- Keywords
- Echinacea, bioavailability, children
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: no participants could be recruited who were eager to donate blood for bioavailability despite prolongation of the study period.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- A. Vogel AGIndustry (pharma, biotech, devices)
- Collaborators
- University Children's Hospital, Zurich
- Study start
- 20 Feb 2017 (actual)
- Primary completion
- 30 Jun 2018 (actual)
- Study completion
- 30 Jun 2018 (actual)
- First posted
- 3 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- 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.
| Arm | Type | Receives |
|---|---|---|
| Echinaforce junior | Experimental | Drug: Echinaforce juniorEchinaforce 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. |
Who may qualify
- Ages
- 4 to 12 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Echinaforce juniorEchinacea Purpurea Extract Pill, sweetened and with orange flavour | Drug | Echinaforce junior |
Primary outcome
Peak Plasma Concentration (Cmax)
Time frame: 270 minutes measurement
Peak concentration of tetraen
2 secondary outcomes
Area under the plasma concentration versus time curve (AUC)
Time frame: 270 minutes measurement
Timepoint when Cmax is reached (tmax)
Time frame: 270 minutes measurement
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2018.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Echinaforce junior in people with Common Cold, run by A. Vogel AG at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 18 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak Plasma Concentration (Cmax) (time frame: 270 minutes measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2018.