Clinical Trials Register

Summary
EudraCT Number:	2010-021571-88
Sponsor's Protocol Code Number:	920‘135
National Competent Authority:	Czechia - SUKL
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-07-22
Trial results	View results

Index
A. PROTOCOL INFORMATION
B. SPONSOR INFORMATION
C. APPLICANT IDENTIFICATION
D. IMP IDENTIFICATION
D.8 INFORMATION ON PLACEBO
E. GENERAL INFORMATION ON THE TRIAL
F. POPULATION OF TRIAL SUBJECTS
G. INVESTIGATOR NETWORKS TO BE INVOLVED IN THE TRIAL
N. REVIEW BY THE COMPETENT AUTHORITY OR ETHICS COMMITTEE IN THE COUNTRY CONCERNED
P. END OF TRIAL

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A. Protocol Information

A.1

Member State Concerned

Czechia - SUKL

A.2

EudraCT number

2010-021571-88

A.3

Full title of the trial

Echinaforce Hotdrink versus Oseltamivir in the Treatment of acute uncomplicated Flu

A.3.1

Title of the trial for lay people, in easily understood, i.e. non-technical, language

Hotdrink and Tamiflu for treatment of flu

A.4.1

Sponsor's protocol code number

920‘135

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	Bioforce AG Roggwil TG
B.1.3.4	Country	Switzerland
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Bioforce AG Roggwil TG
B.4.2	Country	Switzerland
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Phamos CEE s.r.o.
B.5.2	Functional name of contact point	Project Management
B.5.3	Address:
B.5.3.1	Street Address	Krakovská 7
B.5.3.2	Town/ city	Prague
B.5.3.3	Post code	110 00
B.5.3.4	Country	Czech Republic
B.5.4	Telephone number	420222 230 286
B.5.5	Fax number	420222 230 558
B.5.6	E-mail	praha@phamos.cz

D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3	IMP Role	Test
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	No
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Echinaforce Hotdrink
D.3.4	Pharmaceutical form	Syrup
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.3	Other descriptive name	Echinacea purpurea radix et herba
D.3.10	Strength
D.3.10.1	Concentration unit	g/ml gram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0,24
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	Yes
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No
D.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
D.2	Status of the IMP to be used in the clinical trial
D.2.1	IMP to be used in the trial has a marketing authorisation	Yes
D.2.1.1.1	Trade name	Tamiflu
D.2.1.1.2	Name of the Marketing Authorisation holder	Roche Registration Ltd.
D.2.1.2	Country which granted the Marketing Authorisation	European Union
D.2.5	The IMP has been designated in this indication as an orphan drug in the Community	No
D.2.5.1	Orphan drug designation number
D.3 Description of the IMP
D.3.1	Product name	Tamiflu
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.9.1	CAS number	204255-11-8
D.3.9.3	Other descriptive name	OSELTAMIVIR PHOSPHATE
D.3.10	Strength
D.3.10.1	Concentration unit	mg milligram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	75
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	Yes
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	No
	The IMP is a:
D.3.11.3	Advanced Therapy IMP (ATIMP)	No
D.3.11.3.1	Somatic cell therapy medicinal product	No
D.3.11.3.2	Gene therapy medical product	No
D.3.11.3.3	Tissue Engineered Product	No
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	No
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	No
D.3.11.4	Combination product that includes a device, but does not involve an Advanced Therapy	No
D.3.11.5	Radiopharmaceutical medicinal product	No
D.3.11.6	Immunological medicinal product (such as vaccine, allergen, immune serum)	No
D.3.11.7	Plasma derived medicinal product	No
D.3.11.8	Extractive medicinal product	No
D.3.11.9	Recombinant medicinal product	No
D.3.11.10	Medicinal product containing genetically modified organisms	No
D.3.11.11	Herbal medicinal product	No
D.3.11.12	Homeopathic medicinal product	No
D.3.11.13	Another type of medicinal product	No

D.8 Information on Placebo
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Syrup
D.8.4	Route of administration of the placebo	Oral use
D.8 Placebo: 2
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Tablet
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

acute uncomplicated influenza

E.1.1.1

Medical condition in easily understood language

uncomplicated flu

E.1.1.2

Therapeutic area

Diseases [C] - Virus Diseases [C02]

MedDRA Classification

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

To prove the non-inferiority of Echinaforce Hotdrink compared to Tamiflu in patients with symptoms of acute uncomplicated influenza

E.2.2

Secondary objectives of the trial

Safety and tolerability of Echinaforce Hotdrink compared to Tamiflu

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

·Fever defined as body temperature (axillary) ≥37,8°C
· Presence of one or more respiratory symptoms (cough, sore throat, nasal symptoms)
· Presence of one or more constitutional symptoms (headache, malaise, myalgia, sweats and/or chills, fatigue)
· Onset of symptoms < 48 h before randomisation
· Adolescent aged 12 to 17, or adult aged 18 –70
· Weight > 40 kg
· Good general condition
· Signed informed consent

E.4

Principal exclusion criteria

· Subjects with pre-existing influenza symptoms for more than 48 hours at inclusion visit V1
· Suspected bacterial infection
· Bronchitis or Pneumonia
· Intake of antimicrobial agents in the past month
· Antibiotics (Penicilline, Sulfonamides, Quinolones, etc.)
· Antivirals (Zanamivir, Amantadine, Rimantadine, Interferones)
· Benzoic acid
· Broncho Vaxom
· any herbal preparation
· Influenza vaccination in the past 12 months
· Weight < 40 kg
· age of > 70 years at enrolment
· Intake of systemic steroid or immune-suppressive medications at inclusion or in the past 2 months
· Women without appropriate and effective contraception
· Pregnant or breast feeding women
· Chronic cardiac diseases (congenital heart disease, congestive heart failure, coronary artery disease)
· Known endocrine disorders like diabetes mellitus (type 1)
· Liver and kidney disorders
· Respiratory disorders (COPD or cystic fibrosis)
· Known Asthma
· Serious chronic diseases which influence the absorption, me-tabolism and the elimination of the investigational product, especially progressive systemic illnesses like tuberculosis, leukae-mia, collagen disorders and multiple sclerosis
· Other clinically significant chronic diseases
· Known AIDS, HIV-infections and auto-immune diseases
· Illness requiring hospitalisation
· Atopic and allergic subjects (under medicinal treatment)
· Known allergy to plants of the composite family (Asteraceae) or to Oseltamivir
· Known allergy to Paracetamol and Dextromethorphan
· Psychiatric disorders which may influence the results of the trial (epilepsy, suicide attempts)
· Risk population of developing complications: chronic respiratory, cardiovascular (excluding hypertension) or metabolic disorders and immune-compromised
· Neurological and neuro-developmental condition
· Planned surgical intervention during the trial
· Alcohol and/or drug abuse, narcotic drug addiction before and during trial (more than 50 g and / or 10 cigarettes per day)
· Concurrent participation in another clinical trial
· Participation in a clinical trial 30 days prior to this trial
· Incapability of understanding the language in which the information for the patient is given
· The patient is the investigator him/herself

E.5 End points

E.5.1

Primary end point(s)

Cumulative proportion of alleviated patients after 1 day, 5 days and 10 days of treatment, i.e. when influenza symptoms (cough, nasal obstruction, sore throat, fatigue, headache, myalgia and feverish-ness) are rated as absent or mild in the evening and remain so for 24 hours.

E.5.1.1

Timepoint(s) of evaluation of this end point

1 day, 5 days and 10 days of treatment

E.5.2

Secondary end point(s)

Derived from the diary:
· Evaluation of further influenza symptoms (fever, malaise, sweats and/or chills)
· Sleeping disturbance (number of days during study period)
· Time point of return to normal activity
· Use of rescue medication
Reported by the investigator:
· Additional health care contact during the treatment period
· Proportion of subjects with complications (pneumonia, sinusitis, bronchitis, etc.)
· antibiotic use
· Hospitalisation due to influenza
· Final assessment of efficacy and tolerability by patient and investigator

E.5.2.1

Timepoint(s) of evaluation of this end point

daily by means of diary, after 10 days by investigator

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

E.6.3

Therapy

E.6.4

Safety

Yes

E.6.5

Efficacy

Yes

E.6.6

Pharmacokinetic

E.6.7

Pharmacodynamic

E.6.8

Bioequivalence

E.6.9

Dose response

E.6.10

Pharmacogenetic

E.6.11

Pharmacogenomic

E.6.12

Pharmacoeconomic

E.6.13

Others

E.7

Trial type and phase

E.7.1

Human pharmacology (Phase I)

E.7.1.1

First administration to humans

E.7.1.2

Bioequivalence study

E.7.1.3

Other

E.7.1.3.1

Other trial type description

E.7.2

Therapeutic exploratory (Phase II)

E.7.3

Therapeutic confirmatory (Phase III)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

E.8.1.1

Randomised

Yes

E.8.1.2

Open

E.8.1.3

Single blind

E.8.1.4

Double blind

Yes

E.8.1.5

Parallel group

Yes

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

double-dummy

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

E.8.4

The trial involves multiple sites in the Member State concerned

Yes

E.8.4.1

Number of sites anticipated in Member State concerned

E.8.5

The trial involves multiple Member States

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.7

Trial has a data monitoring committee

E.8.8

Definition of the end of the trial and justification where it is not the last visit of the last subject undergoing the trial

last visit last subject

E.8.9 Initial estimate of the duration of the trial

E.8.9.1

In the Member State concerned years

E.8.9.1

In the Member State concerned months

E.8.9.1

In the Member State concerned days

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial days

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	Yes
F.1.1	Number of subjects for this age range:	60
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	Yes
F.1.1.6.1	Number of subjects for this age range:	60
F.1.2	Adults (18-64 years)	Yes
F.1.2.1	Number of subjects for this age range:	400
F.1.3	Elderly (>=65 years)	Yes
F.1.3.1	Number of subjects for this age range:	40
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	500
F.4.2	For a multinational trial
F.4.2.1	In the EEA	500
F.4.2.2	In the whole clinical trial	500

G. Investigator Networks to be involved in the Trial

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-11-16

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-09-01

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2013-05-08

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