Clinical Trials Register

Summary
EudraCT Number:	2012-000341-13
Sponsor's Protocol Code Number:	OTV.PRE.01
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-04-25
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

Germany - BfArM

A.2

EudraCT number

2012-000341-13

A.3

Full title of the trial

Efficacy and Safety of an Herbal-Based Medication vs. Placebo in Preventing Acute Otitis Media in Children at High Risk of Recurrence: A Placebo Controlled, Randomized, Double-blinded Parallel-Group Comparison for Superiority

Wirksamkeit und Sicherheit eines Arzneimittels auf pflanzlicher Basis im Vergleich mit Placebo zur Vorbeugung akuter Mittelohrentzündungen bei Kindern mit hohem Rezidivrisiko

A.3.1

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

Does a herbal-based medicine compared with a placebo (dummy drug) reduce the number of episodes with middle ear infection?

Reduziert ein Medikament auf pflanzlicher Basis im Vergleich mit einem unwirksamen Scheinmedikament (Placebo) die Häufigkeit von Mittelohrentzündungen?

A.3.2

Name or abbreviated title of the trial where available

AOM Prevention

Prävention akuter Mittelohrentzündungen

A.4.1

Sponsor's protocol code number

OTV.PRE.01

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	Weber & Weber GmbH & Co. KG
B.1.3.4	Country	Germany
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	Weber & Weber GmbH & Co. KG
B.4.2	Country	Germany
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Weber & Weber GmbH & Co. KG
B.5.2	Functional name of contact point	Med. Wiss. Dr. rer. nat. U. Danesch
B.5.3	Address:
B.5.3.1	Street Address	Herrschinger Str. 33
B.5.3.2	Town/ city	Inning/Ammersee
B.5.3.3	Post code	82266
B.5.3.4	Country	Germany
B.5.4	Telephone number	4981439270
B.5.5	Fax number	4981437084
B.5.6	E-mail	danesch@weber-weber.net

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	Yes
D.2.1.1.1	Trade name	Otovowen
D.2.1.1.2	Name of the Marketing Authorisation holder	Weber & Weber GmbH & Co. KG
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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.3.4	Pharmaceutical form	Oral drops, solution
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.3.8	INN - Proposed INN	ECHINACEA PURPUREA
D.3.9.1	CAS number	8001002-85-5
D.3.9.3	Other descriptive name	ECHINACEA PURPUREA
D.3.9.4	EV Substance Code	SUB13659MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (V/V) percent volume/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	7.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ACONITUM NAPELLUS
D.3.9.1	CAS number	8001003-18-7
D.3.9.3	Other descriptive name	ACONITUM NAPELLUS DIL. D6
D.3.9.4	EV Substance Code	SUB12737MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (V/V) percent volume/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.75
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CAPSICUM ANNUUM
D.3.9.1	CAS number	8001000-51-9
D.3.9.3	Other descriptive name	CAPSICUM ANNUUM DIL. D4
D.3.9.4	EV Substance Code	SUB13232MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (V/V) percent volume/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.75
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CHAMOMILLA RECUTITA
D.3.9.3	Other descriptive name	CHAMOMILLA RECUTITA
D.3.9.4	EV Substance Code	SUB29812
D.3.10	Strength
D.3.10.1	Concentration unit	% (V/V) percent volume/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2.25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Hydragyrum bicyanatum
D.3.9.3	Other descriptive name	Hydragyrum bicyanatum D6
D.3.10	Strength
D.3.10.1	Concentration unit	% (V/V) percent volume/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.75
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	HYDRASTIS CANADENSIS
D.3.9.1	CAS number	8000054-76-4
D.3.9.3	Other descriptive name	HYDRASTIS CANADENSIS DIL. D4
D.3.9.4	EV Substance Code	SUB14129MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (V/V) percent volume/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.75
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Iodum
D.3.9.3	Other descriptive name	Iodum dil. D4
D.3.10	Strength
D.3.10.1	Concentration unit	% (V/V) percent volume/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.75
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Natrium tetraboracicum
D.3.9.3	Other descriptive name	Natrium tetraboracicum dil. D4
D.3.10	Strength
D.3.10.1	Concentration unit	% (V/V) percent volume/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.75
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SAMBUCUS NIGRA
D.3.9.3	Other descriptive name	SAMBUCUS NIGRA
D.3.9.4	EV Substance Code	SUB29837
D.3.10	Strength
D.3.10.1	Concentration unit	% (V/V) percent volume/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2.25
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SANGUINARIA
D.3.9.1	CAS number	8500011-97-4
D.3.9.3	Other descriptive name	SANGUINARIA
D.3.9.4	EV Substance Code	SUB15191MIG
D.3.10	Strength
D.3.10.1	Concentration unit	% (V/V) percent volume/volume
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.75
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	Yes
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	Oral drops, solution
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

recurrent acute otitis media

rezidivierende akute Mittelohrentzündung

E.1.1.1

Medical condition in easily understood language

repeated middle ear infections

wiederholte Entzündungen des Mittelohres

E.1.1.2

Therapeutic area

Diseases [C] - Ear, nose and throat diseases [C09]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.1
E.1.2	Level	PT
E.1.2	Classification code	10033078
E.1.2	Term	Otitis media
E.1.2	System Organ Class	10021881 - Infections and infestations

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.1
E.1.2	Level	PT
E.1.2	Classification code	10033079
E.1.2	Term	Otitis media acute
E.1.2	System Organ Class	10021881 - Infections and infestations

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 superiority of Otovowen to placebo in the prevention of acute otitis media

E.2.2

Secondary objectives of the trial

1. To investigate that Otovowen is superior to placebo in reducing URI and URI-related doctor visits.
2. To investigate pharmacoeconomic aspects of Otovowen
3. To investigate whether Otovowen is well tolerated and effective as assessed by parents/legal representative(s).
4. To assess safety of Otovowen treatment

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Children aged 12 to 59 months
2. Children with at least 3 episodes of acute otitis media (AOM) since October 1st, 2012 as documented in their medical records. Diagnosis criteria for AOM see study protocol.
3. Written informed consent

E.4

Principal exclusion criteria

1. Ongoing acute otitis media or URI
2. Current prophylaxis/treatment for URI or AOM
3. Current use of phytotherapeutic and homeopathic agents with secretolytic, anti-inflammatory or immune enhancing properties
4. Use of tympanostomy tubes
5. Chronic tympanic membrane perforation (TMP)
6. Palatine cleft
7. Parents/legal representative(s) of children unable to follow study procedures, who have no internet access and are not willing to use an online diary on a weekly basis
8. History of hypersensitivity to the investigational drug or to its ingredients.
9. Systemic, severe as well as history of uncontrolled chronic disease or a concurrent clinically significant illness, or medical condition, which in the investigator’s opinion, would contraindicate study participation or compliance with protocol mandated procedures.
10. Simultaneous participation in another clinical trial or participation in any clinical trial involving an investigational medicinal product within 30 days prior to written informed consent for this trial.

E.5 End points

E.5.1

Primary end point(s)

To determine the number of AOM episodes diagnosed by a physician within 6 months after enrolment per patient. The difference in the mean number of AOMs per patient comparing both parallel groups will be used for testing the hypothesis of superiority of Otovowen.

E.5.1.1

Timepoint(s) of evaluation of this end point

At the end of the individual 6 months observational period

E.5.2

Secondary end point(s)

- Total number of AOM per treatment group
- Number of visits due to AOM
- Number of AOM treated with antibiotics
- Number of visits due to URI
- Number of URI treated with antibiotics
- Number of days with URI
- Subjective evaluation of efficacy by parent
- Subjective evaluation of tolerability by parent
- Adverse events
- Use of antipyretic, analgesic and antibiotic medication
- Number of absent days from daycare (patient) / work (parent)

E.5.2.1

Timepoint(s) of evaluation of this end point

At the end of the individual 6 months observational period

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

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

E.8.2

Comparator of controlled trial

E.8.2.1

Other medicinal product(s)

E.8.2.2

Placebo

Yes

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

LPLV

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

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:

296

F.1.1.1

In Utero

F.1.1.2

Preterm newborn infants (up to gestational age < 37 weeks)

F.1.1.3

Newborns (0-27 days)

F.1.1.4

Infants and toddlers (28 days-23 months)

Yes

F.1.1.4.1

Number of subjects for this age range:

148

F.1.1.5

Children (2-11years)

Yes

F.1.1.5.1

Number of subjects for this age range:

148

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

F.1.3

Elderly (>=65 years)

F.2 Gender

F.2.1

Female

Yes

F.2.2

Male

Yes

F.3 Group of trial subjects

F.3.1

Healthy volunteers

F.3.2

Patients

Yes

F.3.3

Specific vulnerable populations

Yes

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

F.3.3.4

Nursing women

F.3.3.5

Emergency situation

F.3.3.6

Subjects incapable of giving consent personally

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

Children of 12-59 months of age

Kinder im Alter von 12-59 Monaten

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

296

F.5

Plans for treatment or care after the subject has ended the participation in the trial (if it is different from the expected normal treatment of that condition)

standard of care

Standardbehandlung

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

2012-08-20

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-08-28

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-06-01

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