Clinical Trials Register

Summary
EudraCT Number:	2016-004503-31
Sponsor's Protocol Code Number:	PSC-DSGERDAP16
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2018-12-10
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2016-004503-31

A.3

Full title of the trial

Evaluation of the effect of Gerdoff administered in combination to a treatment with protonic pump inhibitors vs the only treatment with protonic pump inhibitors, administered for 6 weeks, on higher symptoms associated to gerd, in patients with first diagnosis of gastroesophageal reflux disease. An open, multicentre, prospective, randomized, double parallel treatment arms study.

Valutazione dell’effetto di GERDOFF® in combinazione ad un trattamento con inibitori della pompa protonica, verso il solo trattamento con inibitori della pompa protonica, somministrati per 6 settimane, sui sintomi alti associati a GERD, in pazienti con prima diagnosi di malattia da reflusso gastroesofageo. Studio clinico policentrico, prospettico, randomizzato, in aperto a due bracci paralleli di trattamento.

A.3.1

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

Evaluation of the treatment with Gerdoff and omeprazole in respect of the treatment with omeprazole only for six weeks in patients suffering of gastroesophageal reflux disease.

Valutazione del trattamento con Gerdoff e omeprazolo rispetto al trattamento con solo omeprazolo per sei settimane in pazienti che soffrono di malattia da reflusso gastroesofageo.

A.3.2

Name or abbreviated title of the trial where available

Evaluation of GERDOFF and PPI in patients affected by GERD

Valutazione di GERDOFF e PPI in pazienti affetti da GERD

A.4.1

Sponsor's protocol code number

PSC-DSGERDAP16

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	SOFAR S.P.A.
B.1.3.4	Country	Italy
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	SOFAR S.p.A.
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	SOFAR S.p.A.
B.5.2	Functional name of contact point	Direzione Scientifica
B.5.3	Address:
B.5.3.1	Street Address	Via Firenze, 40
B.5.3.2	Town/ city	Trezzano Rosa (MI)
B.5.3.3	Post code	20060
B.5.3.4	Country	Italy
B.5.4	Telephone number	02 9093621
B.5.5	Fax number	02 90967239
B.5.6	E-mail	laura.patrucco@sofarfarm.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	OMEPRAZEN - 20 MG CAPSULE RIGIDE GASTRORESISTENTI 14 CAPSULE
D.2.1.1.2	Name of the Marketing Authorisation holder	ISTITUTO FARMACOBIOLOGICO MALESCI 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.3.1	Product name	Omeprazen
D.3.4	Pharmaceutical form	Gastro-resistant capsule, hard
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP
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	Information not present in EudraCT
D.3.11.3.2	Gene therapy medical product	Information not present in EudraCT
D.3.11.3.3	Tissue Engineered Product	Information not present in EudraCT
D.3.11.3.4	Combination ATIMP (i.e. one involving a medical device)	Information not present in EudraCT
D.3.11.3.5	Committee on Advanced therapies (CAT) has issued a classification for this product	Information not present in EudraCT
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Gastroesophageal reflux disease

Malattia da reflusso Gastroesofageo

E.1.1.1

Medical condition in easily understood language

Gastroesophageal reflux disease

Malattia da reflusso Gastroesofageo

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	LLT
E.1.2	Classification code	10018203
E.1.2	Term	GERD
E.1.2	System Organ Class	100000004856

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 evaluate the capacity of GERDOFF to improve higher symptoms in association with PPI (omeprazole) vs. the only treatment with PPI (omeprazole) during 6 weeks of treatment and during the following retention period of 12 weeks.

Valutare la capacità di GERDOFF di migliorare la sintomatologia alta in associazione con PPI (omeprazolo) vs. il solo trattamento con PPI (omeprazolo) durante le 6 settimane di trattamento e durante il successivo periodo di mantenimento di 12 settimane.

E.2.2

Secondary objectives of the trial

To verify in treated patients:
1. number and percentage of Responders/Non-Responders at Visit V4, after 6 weeks of treatment with GERDOFF®+PPI/PPI;
2. number and percentage of patients maintaining the effect of treatment at FU Visit V6 vs. end of study visit V4 after 12 weeks of treatment with GERDOFF® or non-treatment (control group) ;
3. percentage of symptoms frequency reduction at V4, after 6 weeks of treatment, vs the baseline and vs the two groups of treatment;
4. percentage of symptoms frequency reduction at V6, after 18 weeks of treatment, vs V4 and vs. the two groups of treatments;
5. global patient satisfaction in respect of the treatment during the treatment period;
6. the potential concomitant utilization of other medication/products, not allowed, used as “rescue medication” during the first 6 weeks of treatment;
7. the potential concomitant use of “rescue medication”, permitted and not permitted, in the FU period.

Verificare nei pazienti trattati:
1.Numero e percentuale di Responders /Non-Responders alla visita V4, dopo 6 settimane di trattamento con GERDOFF®+PPI/PPI;
2.Numero e percentuale di pazienti che mantengono l’effetto del trattamento alla visita di FU V6 vs la visita di fine studio V4, dopo 12 settimane di trattamento con GERDOFF o di non trattamento (gruppo controllo);
3.Percentuale di riduzione della frequenza dei sintomi alla V4, dopo 6 settimane di trattamento, vs il basale e vs i due gruppi di trattamento;
4.Percentuale di riduzione della frequenza dei sintomi alla V6, dopo 18 settimane di trattamento, vs V4 e vs i due gruppi di trattamento;
5.Soddisfazione complessiva del paziente verso il trattamento nel corso del periodo di trattamento;
6.Eventuale utilizzo concomitante di altri farmaci/prodotti, non ammessi, utilizzati come "rescue medication" nelle prime 6 settimane di trattamento;
7.Eventuale utilizzo concomitante di “rescue medication”, ammesse e non ammesse, nel FU.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Male or female subject;
2. age  18 years;
3. first diagnosis of GERD with higher symptoms, on clinical basis made and confirmed by ORL and/or confirmed by the Gastroenterologist through RSI Questionnaire;
4. presence of extraesophageal symptoms associated to GERD;
5. RSI value ≥ 20;
6. pazients not pre-treated with PPI, also for different problems from GERD, and/or medical devices and/orsimilar products (i.e. alginates) in the last 4 weeks.
7. cooperative patients, able to understand and respect study procedures;
8. patients able to freely provide their written informed consent to study participation;
9. patients who have freely given the consent to the treatment of study related personal data.

1. soggetti maschi o femmine;
2. età  18 anni;
3. prima diagnosi di GERD con sintomi alti, posta su base clinica effettuata e confermata da ORL e/o confermata da Gastroenterologo mediante questionario RSI;
4. presenza di sintomatologia extra-esofagea associata alla GERD;
5. valore RSI ≥ 20;
6. pazienti non pretrattati con PPI, anche per problemi differenti dalla GERD, e/o con dispositivi medici, e/o con prodotti analoghi (es. alginati) nelle ultime 4 settimane.
7. pazienti collaboranti, in grado comprendere le procedure dello studio e di rispettarle;
8. pazienti in grado di dare liberamente il proprio consenso informato scritto di partecipazione allo studio;
9. pazienti che hanno dato liberamente il consenso al trattamento dati personali relativi allo studio.

E.4

Principal exclusion criteria

1. known infective or alkaline or acid esophagitis;
2. acute or chronic rhinosinusitis;
3. chronic bronchitis;
4. known Zollinger-Ellison syndrome, hiatal hernia over 3 cm and Barrett esophagus;
5. ongoing neoplasy;
6. uncontrolled diabetes;
7. patients with impairment hepatic function;
8. patients with rare hereditary problems of galactose intolerance;
9. patients that, according to Investigator’s opinion, cannot be enrolled also due to other diseases or concomitant therapies like atazanavir, nelfinavir, clopidogrel, posaconazolo andd erlotinib (as recommended in the SPC);
10. patient with Lapp lactase deficiency;
11. patients with glucose-galactose malabsorption syndrom;
12. patients with hypersensitivity to omeprazole, to benzimidazolic substitutes or to any of the excipients;
13. patients already in treatment with PPI or similar products;
14. chronic use of medication interfering with salivary secretion (i.e. antistaminics or inhalated steroids);
15. drugs and alcohol abuse;
16. subject unable to adequately express his disorders;
17. patients with planned or established pregnancy or patients not adopting an accepted contraceptive method;
18. brest-feeding patients;
19. missing concession of personal data treatment consent.

1. nota esofagite infettiva o da sostanze acide o alcaline;
2. rinosinusite acuta e cronica;
3. bronchite cronica;
4. nota sindrome di Zollinger-Ellison, ernia jatale superiore a 3 cm ed esofago di Barrett;
5. neoplasie in corso;
6. diabete non controllato;
7. pazienti con funzionalità epatica compromessa;
8. pazienti con rari problemi ereditari di intolleranza al galattosio;
9. pazienti che, a giudizio dello sperimentatore, non possono entrare nel protocollo anche in base ad altre patologie o terapie concomitanti quali ad esempio l’assunzione di atazanavir, nelfinavir, clopidogrel, posaconazolo ed erlotinib (come raccomandato in RCP);
10. pazienti con deficit di Lapp lattasi;
11. pazienti con sindrome da malassorbimento Glu-Gal;
12. pazienti con ipersensibilità ad omeprazolo, ai sostituti benzimidazolici o ad uno qualsiasi degli eccipienti;
13. pazienti già in trattamento con PPI o con prodotti analoghi;
14. uso cronico di farmaci che interferiscono con la secrezione salivare (es. antistaminici o steroidi per uso inalatorio);
15. abuso di droghe e alcol;
16. incapacità da parte del soggetto ad esprimere in modo adeguato i propri disturbi;
17. pazienti con pianificata o accertata gravidanza o che non adottano un metodo anticoncezionale accettato;
18. pazienti in allattamento;
19. mancata concessione del consenso al trattamento dei propri dati personali.

E.5 End points

E.5.1

Primary end point(s)

At Visit V4 (end of the first phase of the study) it will be evaluated the difference in the respect of the baseline of the RSI questionnaire score to verify the effect of the treatment on higher symptoms.

Alla visita V4 (fine prima fase dello studio) sarà valutata la variazione rispetto al basale nello score del questionario RSI per verificare l’effetto dei trattamenti sui sintomi alti.

E.5.1.1

Timepoint(s) of evaluation of this end point

6 weeks

6 settimane

E.5.2

Secondary end point(s)

"Rescue medication" intake, when needed during the FU phase

Il consumo di “rescue medication”, al bisogno nel corso della fase di FU

E.5.2.1

Timepoint(s) of evaluation of this end point

During the 18 weeks of study

Nel corso delle 18 settimane di studio

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

Yes

E.6.4

Safety

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

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

Dispositivo Medico GERDOFF

Medical Device GERDOFF

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.8.5.1

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

Information not present in EudraCT

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

Number of subjects for this age range:

F.1.1.1

In Utero

Information not present in EudraCT

F.1.1.2

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

Information not present in EudraCT

F.1.1.3

Newborns (0-27 days)

Information not present in EudraCT

F.1.1.4

Infants and toddlers (28 days-23 months)

Information not present in EudraCT

F.1.1.5

Children (2-11years)

Information not present in EudraCT

F.1.1.6

Adolescents (12-17 years)

Information not present in EudraCT

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

Yes

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

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

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)

Patients will be treated according to the local clinical practice

I pazienti saranno trattati in accordo alla pratica clinica locale

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

2017-02-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-03-14

P. End of Trial
P.	End of Trial Status	Completed

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