Clinical Trials Register

Summary
EudraCT Number:	2011-005628-16
Sponsor's Protocol Code Number:	Uni-Koeln-1473
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:	2012-05-08
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

2011-005628-16

A.3

Full title of the trial

FTO-genotype dependent weight reduction under treatment with bromocriptin in obese patients

Gewichtsreduktion bei Adipositas unter der Therapie mit Bromocriptin in Abhängigkeit vom FTO-Genotyp

A.3.1

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

FTO-genotype dependent weight reduction under treatment with bromocriptin in obesity

Gewichtsreduktion bei übergewichtigen Patienten unter der Therapie mit dem Medikament Bromocriptin in Abhängigkeit vom FTO-Gen.

A.3.2

Name or abbreviated title of the trial where available

GAB-FTO

A.4.1

Sponsor's protocol code number

Uni-Koeln-1473

A.5.4

Other Identifiers

Name:

DRKS-Number

Number:

DRKS00003349

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	University of Cologne
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	Leibniz-Preis DFG-Projektnummer BR1492/7-1
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	University of Cologne
B.5.2	Functional name of contact point	Dr. Michael Faust
B.5.3	Address:
B.5.3.1	Street Address	Kerpener Str. 62
B.5.3.2	Town/ city	Cologne
B.5.3.3	Post code	50937
B.5.3.4	Country	Germany
B.5.4	Telephone number	004902214784098
B.5.5	Fax number	004902214783783
B.5.6	E-mail	michael.faust@uk-koeln.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	Bromocriptin ratiopharm 2,5mg tablets
D.2.1.1.2	Name of the Marketing Authorisation holder	ratiopharm 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.3.4	Pharmaceutical form	Capsule
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	BROMOCRIPTINE
D.3.9.1	CAS number	25614-03-3
D.3.9.2	Current sponsor code	Bromocriptinmesilat
D.3.9.4	EV Substance Code	SUB05918MIG
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	1,25
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	Capsule
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

Obesity with BMI ≥ 30kg/m²

Adipositas mit einem BMI ≥ 30kg/m²

E.1.1.1

Medical condition in easily understood language

Overweight

Übergewicht

E.1.1.2

Therapeutic area

Diseases [C] - Nutritional and Metabolic Diseases [C18]

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

reduction of BMI

Reduktion des BMI

E.2.2

Secondary objectives of the trial

• Change of delay discounting
• change of reward behaviour (delay discounting) (FEV / questionnaire)
• Change of Body composition

• Veränderung des Belohnungsverhaltens (delay discounting)
• Veränderung des Essverhaltens (FEV / Fragebogen)
• Veränderung der Körperzusammensetzung

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. BMI ≥ 30 kg/m2
2. Age ≥ 18 years
3. Existence of written informed consent

1. BMI ≥ 30kg/m²,
2. Alter ≥ 18 Jahre,
3. Vorliegen einer schriftlichen Einwilligungserklärung des Patienten

E.4

Principal exclusion criteria

1. Known intolerance to bromocriptine or other components oft he IMP
2. Diabetes mellitus type 1 and type 2 (excluded by measurement of HbA1c at the screening visit, exclusion with HbA1c > 6,5%)
3. Hypo- or hyperthyroidism (excluded by measurement of TSH, fT3 and fT4)
4. Pregnancy or lactation
5. Known uncontrolled arterial hypertension (systolic blood pressure > 160mmHg or diastolic blood pressure > 95mmHg; both under antihypertensive treatment)
6. Known coronary heart disease
7. Known peripheral artery occlusive disease (PAOD)
8. Known existence of one of the following hepatic diseases: acute or chronic viral hepatitis, cirrhosis oft he liver
9. Known existence of renal insufficiency, according to a glomerular filtration rate (GFR) ≤ 59 ml/min (calculation according to the MDRD formula)
10. Known existence of Parkinson’s Disease
11. Known existence or history of one of the following psychiatric diseases: major depression, mania, anxiety disorder, obsessive compulsive disorder, schizophrenia, psychosis, addiction
12. Known existence of the following pituitary diseases: hormone secreting microadenoma of the pituitary, pituitary macroadenoma, hypophysitis
13. Treatment with bromocritine in the past 12 month
14. Known existence of a neurodegenerative disorder
15. Known existence of a gastric or intestinal ulcer
16. Known existence of a malignant disease in the past 5 years
17. Known existence of a congestive heart disease (NYHA III or IV)
18. Excess of specific thresholds of laboratory parameters listed in the study protocol
19. Comedication with drugs listed in table 5 (study protocol 4.3.2)
20. Cardiac pacemaker
21. Participation in another interventional study and intake of another investigational drug in the past 21 days
22. Persons who are in a relationship of dependency or who are employed by the sponsor or one of the investigators of the study
23. Accommodation in an institution with court order or official order
24. Non-existence of reliable contraception. Reliable contraception is defined as methods with a Pearl-Index below 1%:
a. Oral hormonal contraception (“pill”)
b. Dermal hormonal contraception
c. Vaginal hormonal contraception (NuvaRing®)
d. contraception pflaster
e. Long active injectable contraception
f. Progesterone-releasing implant (Implanon®)
g. Tubal ligation (female sterilisation)
h. Hormone-releasing intrauterine device (“coil”)

1. Bekannte Überempfindlichkeit gegen Bromocriptin oder andere Inhaltsstoffe des Prüfpräparates
2. Diabetes mellitus Typ 1 und Typ 2 (ausgeschlossen durch Bestimmung des HbA1c im Screening; Ausschluss bei HbA1c > 6,5%)
3. Vorliegen einer Schilddrüsenunterfunktion oder -überfunktion (ausgeschlossen durch Bestimmung des TSH, fT3 und fT4)
4. Schwangerschaft oder Stillzeit
5. Bekanntes Vorliegen einer unkontrollierbaren Hypertonie (systolische Blutdruckwerte unter antihypertensiver Therapie > 160mmHg oder diastolische Blutdruckwerte unter antihypertensiver Therapie > 95mmHg)
6. Bekanntes Vorliegen einer Koronaren Herzerkrankung (KHK)
7. Bekanntes Vorliegen einer peripheren Arteriellen Verschlusskrankheit (pAVK)
8. Bekanntes Vorliegen einer der folgenden Lebererkrankung: akute und chronische Virushepatitis, Leberzirrhose
9. Bekanntes Vorliegen einer mittelschweren chronischen Niereninsuffizienz; entsprechend einer glomerulären Filtrationsrate (GFR) ≤ 59ml/min (Berechnung erfolgt nach der MDRD-Formel)
10. Bekanntes Vorliegen eines Morbus Parkinson
11. Bekanntes aktuelles Vorliegen oder positive Anamnese einer der folgenden psychiatrischen Erkrankungen: endogene Depression, Manie, Angst- und Panikstörung, Zwangsstörung, Schizophrenie, Psychose, Suchterkrankung
12. Bekanntes Vorliegen einer der folgenden hypophysären Erkrankungen: hormonaktives Hypophysenmikroadenom, Hypophysenmakroadenom, Hypophysitis
13. Vortherapie mit Bromocriptin in den letzten 12 Monaten
14. Bekanntes Vorliegen einer dementiellen Erkrankungen
15. Bekanntes Vorliegen eines Magen- bzw. Darmgeschwüres
16. Bekanntes Vorliegen einer malignen Erkrankung in den letzten 5 Jahren
17. Bekanntes Vorliegen einer Herzinsuffizienz entsprechend NYHA III oder IV
18. Überschreiten der Grenzwerte bestimmter laborchemischer Parameter (siehe Evaluationskriterien)
19. Komedikation mit Präparaten siehe Tabelle 5 (siehe 4.3.2.)
20. Tragen eines Herzschrittmachers
21. Teilnahme an anderen interventionellen Prüfungen sowie Erhalt einer anderen Prüfmedikation in den letzten 21 Tagen
22. Personen, die in einem Abhängigkeits- / Arbeitsverhältnis zum Sponsor oder Prüfer stehen
23. Unterbringung in einer Anstalt aufgrund gerichtlicher oder behördlicher Anordnung
24. Fehlende sichere Empfängnisverhütungsmaßnahmen. Als sichere Schwangerschaftsverhütungsmaßnahmen gelten Verfahren mit einem Pearl-Index kleiner 1 %:
a. Orale hormonelle Kontrazeption („Pille“),
b. Dermale hormonelle Kontrazeption,
c. Vaginale hormonelle Kontrazeption (NuvaRing®)
d. Kontrazeptionspflaster,
e. Langzeit wirksame, injizierbare Kontrazeptiva,
f. Progesteron abgebendes Implantat (Implanon®),
g. Tubenligatur (weibliche Sterilisation),
h. Hormon abgebendes Intrauterinpessar („Hormonspirale“),

E.5 End points

E.5.1

Primary end point(s)

BMI

E.5.1.1

Timepoint(s) of evaluation of this end point

after completion of the intake of study medication at week 18. The BMI will be determined additionally in the weeks 1,2,3,4,6,9,12,15,30,42.

nach Beendigung der Einnahme der Studienmedikation in der Woche 18. Weiter wird der BMI in den Wochen 1,2,3,4,6,9,12,15,30,42 bestimmt.

E.5.2

Secondary end point(s)

• Change of delay discounting
• change of reward behaviour (delay discounting) (FEV / questionnaire)
• Change of Body composition

• Belohnungsverhalten (delay discounting)
• Essverhalten (FEV / Fragebogen)
• Körperzusammensetzung

E.5.2.1

Timepoint(s) of evaluation of this end point

After completion of the intake of study medication at week 18. The delay discounting and the FEV will be determined additionally in the weeks 6,12,30,42. The questionnaire concerning the dietary habits will be done additionally in the weeks 1,2,3,4,6,9,12,15. Body composition will be determined additonally in the weeks 6 and 12.

Nach Beendigung der Einnahme der Studienmedikation in der Woche 18. Das Belohnungsverhalten und der FEV werden zusätzlich in den Wochen 6,12,30,42 bestimmt. Der Fragebogen bzgl. des Essverhaltens wird zusätzlich in den Wochen 1,2,3,4,6,9,12,15 bestimmt. Die Körperzusammensetzung wird zusätzlich in den Wochen 6 und 12 bestimmt.

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

Yes

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

Yes

E.8.4

The trial involves multiple sites in the 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

LVLS

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)

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

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)

treatment after completion of the trail will be normal treatment for that condition.

Die Behandlung nach Studienende entspricht der normalen Behandlung von Patienten mit dieser Indikation.

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

2012-08-06

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-05-21

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2015-06-03

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Orphan Designation Number:
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