Clinical Trials Register

Summary
EudraCT Number:	2015-000197-35
Sponsor's Protocol Code Number:	IR-HP-14-01
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2016-03-11
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2015-000197-35

A.3

Full title of the trial

insulin resistance, obesity and gastrointestinal bacteria

Insulino-Resistenza, Obesità e Batteri Gastrointestinali

A.3.1

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

insulin resistance, obesity and gastrointestinal bacteria

Insulino-Resistenza, Obesità e Batteri Gastrointestinali

A.3.2

Name or abbreviated title of the trial where available

HR-HP-14-01

A.4.1

Sponsor's protocol code number

IR-HP-14-01

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	AOU DI BOLOGNA POLICLINICO S.ORSOLA-MALPIGHI
B.1.3.4	Country	Italy
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	Ministero della Salute
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	AOU di Bologna, Policlinico S.Orsola-Malpighi
B.5.2	Functional name of contact point	U.O. Medicina Interna (Direttore St
B.5.3	Address:
B.5.3.1	Street Address	Via Albertoni 15
B.5.3.2	Town/ city	Bologna
B.5.3.3	Post code	40138
B.5.3.4	Country	Italy
B.5.4	Telephone number	051-6364134
B.5.5	Fax number	051-392486
B.5.6	E-mail	federico.perna@unibo.it

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	PANTORC - 14 COMPRESSE GASTRORESISTENTI DA 40 MG IN BLISTER
D.2.1.1.2	Name of the Marketing Authorisation holder	TAKEDA ITALIA S.P.A.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	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.3.8	INN - Proposed INN	PANTOPRAZOLO SODICO SESQUIDRATO
D.3.9.1	CAS number	164579-32-2
D.3.9.2	Current sponsor code	na
D.3.9.3	Other descriptive name	PANTOPRAZOLE SODIUM SESQUIHYDRATE
D.3.9.4	EV Substance Code	SUB21564
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	80
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	KLACID - 500 MG COMPRESSE RIVESTITE A RILASCIO MODIFICATO 14 CPR
D.2.1.1.2	Name of the Marketing Authorisation holder	ABBOTT S.R.L.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	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.3.8	INN - Proposed INN	CLARITROMICINA
D.3.9.2	Current sponsor code	na
D.3.9.3	Other descriptive name	CLARITHROMYCIN
D.3.9.4	EV Substance Code	SUB06641MIG
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	1000
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: 3
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	ZIMOX - 1 G COMPRESSE 12 COMPRESSE
D.2.1.1.2	Name of the Marketing Authorisation holder	PFIZER ITALIA S.R.L.
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	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.3.8	INN - Proposed INN	AMOXICILLINA TRIIDRATO
D.3.9.2	Current sponsor code	na
D.3.9.3	Other descriptive name	AMOXICILLIN TRIHYDRATE
D.3.9.4	EV Substance Code	SUB00504MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2
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

Helicobacter pylori infection

Infezione da Helicobacter pylori

E.1.1.1

Medical condition in easily understood language

Helicobacter pylori infection

Infezione da Helicobacter pylori

E.1.1.2

Therapeutic area

Diseases [C] - Bacterial Infections and Mycoses [C01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.1
E.1.2	Level	PT
E.1.2	Classification code	10022489
E.1.2	Term	Insulin resistance
E.1.2	System Organ Class	10027433 - Metabolism and nutrition disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.1
E.1.2	Level	LLT
E.1.2	Classification code	10004028
E.1.2	Term	Bacterial infection due to helicobacter pylori (H. pylori)
E.1.2	System Organ Class	100000004862

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 primary objective of the study is to evaluate the effects of eradication of Helicobacter pylori in patients with proven hyper-insulinismo, using drug treatment as a standard triple therapy (40 mg pantoprazole, clarithromycin 500 mg and amoxicillin 1 g twice daily for 10 days) on insulin resistance, with an interventional study with medicine, randomized, double-blind, placebo-controlled study.

L’obiettivo primario dello studio è di valutare gli effetti dell’eradicazione dell’Helicobacter pylori, in soggetti con comprovato iper-insulinismo, utilizzando come trattamento farmacologico una triplice standard terapia (pantoprazolo 40 mg, claritromicina 500 mg e amoxicillina 1 g, due volte al giorno per 10 giorni) sulla resistenza all'insulina, con uno studio interventistico con medicinale, randomizzato in doppio cieco, controllato verso placebo.

E.2.2

Secondary objectives of the trial

Secondary objectives of the study are:
1) compare the role of eradication on the endpoint to a possible primary role of antibiotics;
2) evaluate, with methods of proteomics, the plasma of patients enrolled to clarify the pathophysiology of insulin resistance;
3) assessing, metabolomics methods, the plasma of patients enrolled to clarify the pathophysiology of insulin resistance
4) assess the possible variation of the intestinal flora before and after drug treatment using genomic analysis of bacterial fecal sample;
5) whether the set of metabolic and inflammatory patients with proven hyper-insulinismo but negative to infection by Helicobacter pylori infection differs from the positive group and the group turned negative to infection as a result of eradication treatment.

Gli obiettivi secondari dello studio sono:
1) confrontare il ruolo dell’eradicazione sull’end-point primario verso un possibile ruolo degli antibiotici;
2) valutare, con metodiche di proteomica, il plasma dei pazienti arruolati per chiarire la fisiopatologia dell’insulino-resistenza;
3) valutare, con metodiche di metabolomica, il plasma dei pazienti arruolati per chiarire la fisiopatologia dell’insulino-resistenza
4) valutare l’eventuale variazione della flora batterica intestinale prima e dopo il trattamento farmacologico mediante analisi genomica batterica del campione fecale;
5) valutare se l’assetto metabolico ed infiammatorio dei pazienti con comprovato iper-insulinismo ma negativi all’infezione da Helicobacter pylori, differisce dal gruppo positivo all’infezione e dal gruppo divenuto negativo all’infezione a seguito del trattamento eradicante.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• proven hyper-insulinismo (using OGTT)
• BMI> 24.9 kg / m2 and <39.9 kg / m2
• Age ≥ 18 years and ≤ 65
• Informed consent 1 [ for the immunoassay on stool]
• Informed consent 2 [for Visit1 enrollment]

• comprovato iper-insulinismo (mediante OGTT)
• BMI > 24,9 Kg/m2 e < 39,9 Kg/m2
• Età ≥ 18 Anni e ≤ 65
• Consenso informato 1 [per esuguire il test rapido immunocromatografico sulle feci]
• Consenso informato 2 [per effettivo arruolamento]

E.4

Principal exclusion criteria

Patients who have already performed a therapy for the eradication of Helicobacter pylori, including proton pump inhibitors, preparations of bismuth, prokinetic or antibiotics in the two previous months;
• Patients who make use of drugs including anti-inflammatory and / or aspirin, glucose and lipid-lowering agents; alcohol addiction; previous gastric surgery; decompensated congestive heart failure; liver cirrhosis; chronic renal failure; diagnosis of cancer; pregnancy; systemic or local infections
• Women of childbearing potential not using contraception and breastfeeding women;
• Known or suspected hypersensitivity to the drug or drug class in the studio;
• Patients with serious medical conditions that, in the opinion of the investigator, contraindicate the patient's participation in the study;
• Use of experimental drugs in the last three months prior to study entry.

• Pazienti che hanno già eseguito una terapia per l’eradicazione dell’Helicobacter pylori, tra cui inibitori della pompa protonica, preparati a base di bismuto, procinetici o antibiotici nei due mesi precedenti;
• Pazienti che fanno uso di farmaci tra cui anti-infiammatori e/o aspirina, glucosio e agenti ipolipemizzanti; dipendenza da alcol; precedenti interventi di chirurgia gastrica; insufficienza cardiaca congestizia scompensata; cirrosi epatica; insufficienza renale cronica; diagnosi di tumore; gravidanza; infezioni sistemiche o locali
• Donne in età fertile che non utilizzano metodi contraccettivi e donne in allattamento;
• Nota o sospetta ipersensibilità al farmaco o alla classe farmacologica in studio;
• Pazienti con gravi condizioni cliniche che, a giudizio dello sperimentatore, controindicano la partecipazione del paziente allo studio;
• Utilizzo di farmaci sperimentali negli ultimi 3 mesi prima dell’inclusione nello studio.

E.5 End points

E.5.1

Primary end point(s)

evaluate, with a prospective, double-blind,randomized, placebo-controlled study the effects of Helicobacter Pylori eradication on insulin resistance as well as the serum/plasma related markers.

valutare gli effetti dell’eradicazione dell’Helicobacter pylori, in soggetti con comprovato iper-insulinismo, utilizzando come trattamento farmacologico una triplice standard terapia (pantoprazolo 40 mg, claritromicina 500 mg e amoxicillina 1 g, due volte al giorno per 10 giorni) sulla resistenza all'insulina

E.5.1.1

Timepoint(s) of evaluation of this end point

30 days

30 giorni

E.5.2

Secondary end point(s)

compare the role of eradication on the endpoint to a possible primary role of antibiotics; 2) evaluate, with methods of proteomics, the plasma of patients enrolled to clarify the pathophysiology of insulin resistance; 3) assessing, metabolomics methods, the plasma of patients enrolled to clarify the pathophysiology of insulin resistance 4) assess the possible variation of the intestinal flora before and after drug treatment using genomic analysis of bacterial fecal sample; 5) whether the set of metabolic and inflammatory patients with proven hyper-insulinismo but negative to infection by Helicobacter pylori infection differs from the positive group and the group turned negative to infection as a result of eradication treatment.

confrontare il ruolo dell’eradicazione sull’end-point primario verso un possibile ruolo degli antibiotici; 2) valutare, con metodiche di proteomica, il plasma dei pazienti arruolati per chiarire la fisiopatologia dell’insulino-resistenza; 3) valutare, con metodiche di metabolomica, il plasma dei pazienti arruolati per chiarire la fisiopatologia dell’insulino-resistenza 4) valutare l’eventuale variazione della flora batterica intestinale prima e dopo il trattamento farmacologico mediante analisi genomica batterica del campione fecale; 5) valutare se l’assetto metabolico ed infiammatorio dei pazienti con comprovato iper-insulinismo ma negativi all’infezione da Helicobacter pylori, differisce dal gruppo positivo all’infezione e dal gruppo divenuto negativo all’infezione a seguito del trattamento eradicante.

E.5.2.1

Timepoint(s) of evaluation of this end point

30 days

30 giorni

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

E.6.5

Efficacy

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)

E.7.4

Therapeutic use (Phase IV)

Yes

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

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.8.5.1

Number of sites anticipated in the EEA

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:

100

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

100

F.4.2

For a multinational trial

F.4.2.1

In the EEA

100

F.4.2.2

In the whole clinical trial

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)

normal care

normale percorso assistenziale

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

2015-05-12

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2015-06-09

P. End of Trial
P.	End of Trial Status	Ongoing

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