Clinical Trials Register

Summary
EudraCT Number:	2013-000891-13
Sponsor's Protocol Code Number:	STW5-II/212-D-12-II-F;IMP17155
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2014-06-24
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Germany - BfArM

A.2

EudraCT number

2013-000891-13

A.3

Full title of the trial

A randomised, double-blind, placebo-controlled multi-centre study to investigate the effectiveness and safety of STW5-II as add-on treatment for induction of remission in patients with mild to moderate ulcerative colitits

Eine randomisierte, doppelblinde, plazebokontrollierte Studie zur Wirksamkeit und Unbedenklichkeit von STW5-II als Zusatzmedikation bei Patienten mit milder bis moderater Colitis ulcerosa zur Herbeiführung der Remission.

A.3.1

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

Study with the herbal preparation STW5-II in patients with mild to moderate ulcerative colitis (chronic inflammatory bowel disease)

Studie mit dem pflanzlichen Arzneimittel STW5-II bei Patienten mit leichter bis mittelschwerer Colitis ulcerosa (chronisch-entzündliche Darmerkrankung)

A.4.1

Sponsor's protocol code number

STW5-II/212-D-12-II-F;IMP17155

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	Steigerwald Arzneimittelwerk GmbH
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	Steigerwald Arzneimittelwerk GmbH
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	Steigerwald Arzneimittelwerk GmbH
B.5.2	Functional name of contact point	Klinische Forschung
B.5.3	Address:
B.5.3.1	Street Address	Havelstr. 5
B.5.3.2	Town/ city	Darmstadt
B.5.3.3	Post code	64295
B.5.3.4	Country	Germany
B.5.4	Telephone number	4961513305189

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	Iberogast N
D.2.1.1.2	Name of the Marketing Authorisation holder	Steigerwald Arzneimittelwerk GmbH
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.3.1	Product name	Iberogast N
D.3.2	Product code	STW5-II
D.3.4	Pharmaceutical form	Oral drops, liquid
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	Bitterschleifenblume-ganzpflanze 1,5ml/10ml
D.3.9.3	Other descriptive name	BITTER CANDYTUFT FRESH PLANT EXTRACT
D.3.9.4	EV Substance Code	SUB121423
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	15
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Kümmel 2ml/10ml
D.3.9.3	Other descriptive name	CARVI EXTRACTUM FLUIDUM
D.3.9.4	EV Substance Code	SUB88787
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	20
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Pfefferminzblätter 1ml/10ml
D.3.9.3	Other descriptive name	MENTHA × PIPERITA L. FOLIUM
D.3.9.4	EV Substance Code	SUB30212
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Süßholzwurzel 1ml/10ml
D.3.9.3	Other descriptive name	GLYCYRRHIZA GLABRA ROOT
D.3.9.4	EV Substance Code	SUB32404
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Kamillenblüten 3ml/10ml
D.3.9.3	Other descriptive name	MATRICARIA RECUTITA L. FLOS
D.3.9.4	EV Substance Code	SUB30207
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	30
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Melissenblätter 15ml/10ml
D.3.9.3	Other descriptive name	MELISSAE FOLII DRY AQUEOUS EXTRACT
D.3.9.4	EV Substance Code	SUB30854
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	15
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)	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	Yes
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	Oral drops, liquid
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

Ulcerative colitis

Colitis ulcerosa

E.1.1.1

Medical condition in easily understood language

Ulcerative colitis

Colitis ulcerosa

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

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

The objective of the present study is to assess the efficacy and safety of STW5-II as add-on treatment for induction of remission in patients with mild to moderate ulcerative colitis (UC) in an acute flare, including remission rate, time to remission, Quality of life.

Die Endpunkte beurteilen die Wirksamkeit, Sicherheit und Verträglichkeit von STW5-II als Zusatztherapie bei der Remissionserreichung von Patienten mit milder bis moderater Colitis ulcerosa im akuten Schub, einschließlich
der Zeit bis zum Eintritt der Remission und der Lebensqualität.

E.2.2

Secondary objectives of the trial

Not applicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Patients with confirmed ulcerative colitis (UC) by symptoms, endoscopy and histology
- Patients with mild to moderate active ulcerative colitis (UC), i.e. CAI ≥ 5 up to 10 points (including)
- Patients in whom the active UC is treated independent from any participation in the current study with oral mesalazine at least 14 days but not more than 28 days before Visit 2
- Age between 18 to 80 years (including)
- UC may reach from left-sided colitis to pancolitis
- Willing and able to understand and sign an approved Informed Consent form.

- Patienten mit Colitis Ulcerosa (CU), diagnostiziert durch Symptome, Endoskopie und Histologie
- Patienten mit milder bis moderater Colitis Ulcerosa (CU), d.h. CAI ≥ 5 bis zu 10 Punkten (einschließlich)
- Patienten deren CU unabhängig von der Teilnahme in der vorliegenden Studie mit oralem Mesalazin behandelt wird und deren Mesalazintherapie mindestens 14 Tage bis maximal 28 Tage vor Visite 2 begonnen wurde.
- Alter zwischen 18 und 80 Jahren (einschließlich)
- Ausdehnung der CU von Linksseiten Colitis bis zur Pancolitis
- Patienten, die bereit und in der Lage sind die Informierte Einwilligung zu unterzeichnen

E.4

Principal exclusion criteria

- Severe forms of UC (CAI > 10)
- Crohn’s disease, infectious colitis or undetermined colitis
- Steroid dependence and steroid resistance
- Concomitant medication with oral steroids, oral or topic budesonide, biologicals, immune modifiers, immunosuppressants
- Topical mesalazin application
- Antibiotics at screening visit, during the course of the study a short-term use in non-colitic afflictions is allowed, and is documented
- Prior medication with biologicals, immune modifiers and immunosuppressants < 3 month wash-out
- Anticoagulant medication
- Any condition or concomitant therapy that in the opinion of the investigator may jeopardize the patients well-being
- Total colectomy
- Known allergies to components of STW5-II
- Severe allergic diathesis
- History of current or past alcohol or drug abuse
- Known intolerance to azo dyes E110 und E151
- Severe comorbidity
- Consumption of any investigational product within one month prior to the screening visit

- Schwere Formen der CU (CAI > 10)
- Morbus Crohn, infektiöse Colitis oder undifferenzierte Colitis
- Steroidabhängigkeit oder Steroidresistenz
- Begleitmedikation orale Steroide, orales oder topisches Budesonid, Biologika, Immunmodulatoren, Immunsuppressiva
- Topische Mesalazinanwendung
- Antibiotikaeinnahme zur Visite 1; während des Studienverlaufs ist eine kurzfristige Antibiotikaeinnahme für nicht colitisbezogene Beschwerden erlaubt und wird dokumentiert
- Vorangegangene Therapie mit Biologika, Immunmodulatoren und Immunsuppressiva mit einer Auswaschphase von < 3 Monaten
- Therapie mit Antikoagulantien
- Sonstige Bedingungen oder Begleitmedikation, die der Prüfer als Gefährdung für das Wohlbefinden des Patienten beurteilt
- Totale Kolektomie
- Bekannte Allergien gegen Inhaltsstoffe von STW5-II
- Schwere allergische Diathese
- Bekannte Alkohol- oder Drogenabhängigkeit
- Bekannte Unverträglichkeit gegen Azofarbstoffe E110 und E151
- Schwere Begleiterkrankungen

E.5 End points

E.5.1

Primary end point(s)

Remission Rate at final visit (Week 12) investigated with CAI. Responder Definition: patients with Remission. Remission is defined as CAI ≤ 4.
- Change of endoscopic index [EI]
- Change of histological index [HI] based on Riley
- Incidence of sustained remissions (proportion of patients reaching a clinical CAI ≤ 2 points at Week 12 with remission acc. to Rachmilewitz)
- Time to remission (CAI ≤ 4 points): days from Day 0 until first remission is reached
- Time to sustained remission (CAI ≤ 2 points): days from Day 0 until first sustained remission is reached
- Number of patients who reached a remission at least once during the course of the study
- Number of patients who reached a sustained remission at least once during the course of the study
- Change from baseline of absolute CAI values to final visit (Day 0 to Week 12)
- Change from baseline in Inflammatory Bowel Disease Questionnaire (IBDQ-D) (German version) at final visit (Day 0 to Week 12)
- Change from baseline in Irritable Bowel Severity Score (IBSS) at final visit (Day 0 to Week 12)
- Change from baseline in EuroQol 5 dimensions questionnaire (EQ-5D) at final visit (Day 0 to Week 12)
- (Partial) Mayo Score throughout the study
- Determination of changes in UC markers C-reactive protein (CRP), calprotectin, lactoferrin, polymorphonuclear (PMN) elastase for determination of parameters associated with acute flare of UC patients
- Change of oral mesalazine dose throughout the study period.

Ansprechrate (Anteil an Patienten, die einen klinischen CAI ≤ 4 Punkte zur finale Visite (Woche 12) erreichen) bezogen auf die Remission nach Rachmilewitz (Aktivitätsindex [CAI])
- Veränderung im Endoskopischen Index [EI]
- Veränderung im Histologischen Index [HI] basierend auf Riley
- Inzidenz einer anhaltenden Remission (Anteil an Patienten, die einen klinischen CAI ≤ 2 Punkte zur finale Visite (Woche 12) erreichen) bezogen auf die Remission nach Rachmilewitz
- Zeit bis zum Eintritt der Remission (CAI ≤ 4 Punkte): Anzahl der Tage von Tag 0 bis zum Eintritt der Remission
- Zeit bis zum Eintritt der anhaltenden Remission (CAI ≤ 2 Punkte): Anzahl der Tage von Tag 0 bis zum Eintritt der anhaltenden Remission
- Anzahl an Patienten, die mindestens einmal im Verlauf der Studie in Remission waren
- Anzahl an Patienten, die mindestens einmal im Verlauf der Studie in anhaltender Remission waren
- Veränderung der absoluten CAI Werte (Tag 0 bis Woche 12)
- Veränderung des IBDQ-D vom Behandlungsbeginn bis zur finalen Visite (Tag 0 bis Woche 12)
- Veränderung des IBSS vom Behandlungsbeginn bis zur finalen Visite (Tag 0 bis Woche 12)
- Veränderung des EQ-5D vom Behandlungsbeginn bis zur finalen Visite (Tag 0 bis Woche 12)
- (Partieller) Mayo Score während der Studie
- Veränderung der CU Marker im Verlauf der Studie
- Veränderung der oralen Mesalazindosis im Verlauf der Studie

E.5.1.1

Timepoint(s) of evaluation of this end point

see E.5.1

vgl. E.5.1

E.5.2

Secondary end point(s)

Not applicable

E.5.2.1

Timepoint(s) of evaluation of this end point

Not applicable

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

Yes

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)

Yes

E.7.3

Therapeutic confirmatory (Phase III)

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

The end of the study is defined as the day of blind data review meeting

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

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)

F.1.1.5

Children (2-11years)

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

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

Yes

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

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

100

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)

After discontinuation / termination of the trial, patients will be treated according to the discretion of their physicians. Mesalazin may be continued as well as a marketed product (Iberogast ®) which is similar to the IMP is available for a continued therapy.

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

2014-07-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-06-25

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2015-12-02

Select Country:	Select Age Range:
Select Trial Status:	Select Trial Phase:
Select Gender:
Select Date Range: to
Select Rare Disease:
IMP with orphan designation in the indication
Orphan Designation Number:
Results Status:
Clear advanced search filters

Austria
Belgium
Bulgaria
Croatia
Cyprus
Czechia
Denmark
Estonia
Finland
France
Germany
Greece
Hungary
Iceland
Ireland
Italy
Latvia
Liechtenstein
Lithuania
Luxembourg
Malta
Netherlands
Norway
Poland
Portugal
Romania
Slovakia
Slovenia
Spain
Sweden
United Kingdom
Outside EU/EEA

Clinical trials