Clinical Trials Register

Summary
EudraCT Number:	2009-015537-67
Sponsor's Protocol Code Number:	2009-08-17
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:	2009-10-26
Trial 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

2009-015537-67

A.3

Full title of the trial

Untersuchung der Wirksamkeit und Sicherheit von Vareniclin in der Postakutbehandlung der Alkoholabhängigkeit - eine prospektive, bizentrische, doppelblinde, placebokontrollierte, randomisierte Phase II Studie

A.3.1

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

Postaktutbehandlung der Alkoholabhängigkeit

A.4.1

Sponsor's protocol code number

2009-08-17

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	Universitätsmedizin der Johannes Gutenberg-Universität Mainz
B.1.3.4	Country	Germany
B.3.1 and B.3.2	Status of the sponsor	Non-Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	Universitätsmedizin der Johannes Gutenberg-Universität Mainz
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	Interdisziplinäres Zentrum Klinische Studien Mainz
B.5.2	Functional name of contact point	Tobias Wittig
B.5.3	Address:
B.5.3.1	Street Address	Langenbeckstraße 2
B.5.3.2	Town/ city	Mainz
B.5.3.3	Post code	55131
B.5.3.4	Country	Germany
B.5.4	Telephone number	4906131179917
B.5.5	Fax number	4906131179914
B.5.6	E-mail	wittig@izks-mainz.de

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	Champix 0,5 mg Filmtabletten
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, Great Britain
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.3.4	Pharmaceutical form	Film-coated 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	375815-87-5
D.3.9.3	Other descriptive name	VARENICLINE TARTRATE
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	0.5
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.IMP: 2
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	Champix 1 mg Filmtabletten
D.2.1.1.2	Name of the Marketing Authorisation holder	Pfizer Limited, Ramsgate Road, Sandwich, Kent, CT13 9NJ, Great Britain
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.3.4	Pharmaceutical form	Film-coated 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	375815-87-5
D.3.9.3	Other descriptive name	VARENICLINE TARTRATE
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	1
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	Film-coated 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

Alcohol dependence

E.1.1.1

Medical condition in easily understood language

Alcohol dependence

E.1.1.2

Therapeutic area

Psychiatry and Psychology [F] - Psychological processes [F02]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10001594
E.1.2	Term	Alcohol dependence syndrome
E.1.2	System Organ Class	10037175 - Psychiatric disorders

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 analyse the efficacy and safety of varenicline (Champix) versus placebo for relapse prevention in post-acute treatment (7-21 after last drink) in alcohol dependent patients.

E.2.2

Secondary objectives of the trial

Investigation of drinking-quantity reducing properties of varenicline in a group of alcohol dependent patients, as measured by
- Amount of alcoholic drinks per drinking day
- Percentage of heavy drinking days (more than six standard drinks for a man and four standard drinks for a woman)
Safety and tolerability of varenicline in post-acute treatment in alcohol dependent patients
Investigation of alcohol craving with the OCDS and VAS
Measurement the overall clinical impression (CGI)
Measurement of quality of life (SF-12 questionnaire)
Measurement of the frequency of smoking (number of cigarettes per day and percentage of abstinent days)
Measurement of nicotine dependence severity (Fagerstrom Index for Nicotine Dependence - FTND)
Measurement of severity of depression (Beck Depression Inventory - BDI)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Alcohol dependent as defined by the criteria of Diagnostic and Statistical Manual of mental disorders (DSM IV)
Male and female in- or outpatients
Current smoker
Aged 18 to 65 years
Last consumption of alcohol 7-21 days before randomisation
Detoxified and free of withdrawal symptoms at randomisation
Sufficient knowledge of German language
Able to follow verbal and written instructions
Able to provide written informed consent

E.4

Principal exclusion criteria

Delirium after current withdrawal, alcohol-induced dementia, Wernicke-Korsakoff syndrome
Severe renal insufficiency
Severe liver insufficiency
Involutary Detoxification
Female patients pregnant, breast feeding or fo child bearing age and not protected by medically acceptable contraception
Patients with clinically relevant concomitant psychiatric discorders (including a major depressive episode, psychotic discorders, antisocial personality disorder according to DSM IV in medial history)
Patients with an addiction or substance abuse of other addiction-inducing substances (except nicotine or cannabis) within the last 24 months before inclusion in the trial
Patient having a current suicide risk with a score > 6 at the suicidality item C of the M.I.N.I. international neuropsychiatric interview (MINI)
Patients with any clinically significant acute or chronic progressive neurological, gastrointestinal, cardiovascular, hepatic, renal, hematological, endocrine, dermatological or respiratory disease
Patients with a current relevant depression (Hamilton Rating Scale for Depression (German version) values ≥ 9 or Beck Depression Inventory (German version) values ≥ 12)
Patients with a history of cancer within the last five years
Patients with a history of stroke or myocardial infarction within the last 6 months before screening

E.5 End points

E.5.1

Primary end point(s)

Percent of days abstinent from any alcohol (TLFB) during 12-weeks treatment

E.5.1.1

Timepoint(s) of evaluation of this end point

after 12 weeks of treatment

E.5.2

Secondary end point(s)

• Zeit bis zum ersten alkoholischen Getränk/ Trinkzwischenfall (in Tagen), erfasst mittels Time-Line-Follow-Back Interview
• Anteil dauerhaft abstinenter Patienten während der Behandlung
(in Prozent der Anzahl der Patienten)
• Anzahl der Standarddrinks pro Trinktag, erfasst mittels Time-Line-Follow-Back Interview
• Zeit bis zum ersten schweren Trinken (in Tagen), erfasst mittels Time-Line-Follow-Back Interview
• Anzahl der Tage mit schwerem Trinken (in Prozent der Behandlungstage), erfasst mittels Time-Line-Follow-Back Interview
• Veränderungen der Gamma-Glutamyl-Transferase (ץ-GT)
• Unerwünschte Ereignisse
• Compliance der Patienten
• Alkohol Craving gemessen mit der Obsessive Compulsive Drinking Scale (OCDS) und einer Visuellen Analog Skala des Cravings (VAS)
• Schweregrad der Alkoholabhängigkeit gemessen mit dem EuropASI (siehe 6.1.1.9)
• Globale Zustandsveränderung gemessen mit der
Clinical Global Impression of Change (CGI)
• Lebensqualität (SF-12 Fragebogen)
• Intensität des Rauchens (Anzahl der Zigaretten/Tag und CO-Messung)
• Die Anzahl der nikotinabstinenten Behandlungstage (in Prozent der Behandlungstage)
• Schwere der Nikotinabhängigkeit gemessen mit dem Fagerstrom Test der Nikotinabhängigkeit (FTND)
• Intensität der depressiven Beschwerden
[gemessen mit dem Beck Depressions Inventar (BDI)]

E.5.2.1

Timepoint(s) of evaluation of this end point

after 12 weeks of treatment

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)

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

end of trial ist last visit of the last patient

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

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)

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

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)

see protocoll chapter 3.6.2 and chapter 4.1.7

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

2009-11-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2009-11-19

P. End of Trial
P.	End of Trial Status	Prematurely Ended
P.	Date of the global end of the trial	2013-10-04

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