Clinical Trials Register

Summary
EudraCT Number:	2018-001275-21
Sponsor's Protocol Code Number:	TAK-906-2002
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2020-11-10
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

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A. Protocol Information

A.1

Member State Concerned

Italy - Italian Medicines Agency

A.2

EudraCT number

2018-001275-21

A.3

Full title of the trial

A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 2b Study to Evaluate the Efficacy and Safety of Twice-Daily Oral Administration of a Peripherally Acting Dopamine Receptor D2/D3 Antagonist, TAK-906 for the Treatment of Adult Subjects With Symptomatic Idiopathic or Diabetic Gastroparesis

Studio di fase 2b, multicentrico, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli, volto a valutare l’efficacia e la sicurezza di due somministrazioni orali giornaliere di un antagonista dei recettori dopaminergici D2/D3 ad azione periferica, TAK-906, per il trattamento di soggetti adulti con gastroparesi idiopatica o diabetica sintomatica

A.3.1

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

TAK-906, Parallel-Group, Phase 2b Dose Response, Efficacy and Safety Study in Adult Subjects With Symptomatic Idiopathic or Diabetic Gastroparesis

Studio con TAK-906, a gruppi paralleli, fase 2b dose risposta, per valutarne l’efficacia e la sicurezza in soggetti adulti con gastroparesi idiopatica o diabetica sintomatica

A.3.2

Name or abbreviated title of the trial where available

A.4.1

Sponsor's protocol code number

TAK-906-2002

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	MILLENNIUM PHARMACEUTICALS, INC.
B.1.3.4	Country	United States
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	Millennium Pharmaceuticals, Inc., a wholly owned subsidiary of Takeda Pharmaceutical Company Limited
B.4.2	Country	United States
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Takeda Pharmaceuticals International, Co.
B.5.2	Functional name of contact point	Mark Patti
B.5.3	Address:
B.5.3.1	Street Address	350 Massachusetts Avenue
B.5.3.2	Town/ city	Cambridge, MA
B.5.3.3	Post code	02139
B.5.3.4	Country	United States
B.5.4	Telephone number	0016174441281
B.5.5	Fax number	0016175514965
B.5.6	E-mail	mark.patti@takeda.com

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	No
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	TAK-906
D.3.2	Product code	[TAK-906]
D.3.4	Pharmaceutical form	Capsule, hard
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	1352993-39-5
D.3.9.2	Current sponsor code	TAK-906
D.3.9.4	EV Substance Code	SUB195443
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	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	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.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	No
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	TAK-906
D.3.2	Product code	[TAK-906]
D.3.4	Pharmaceutical form	Capsule, hard
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	1352993-39-5
D.3.9.2	Current sponsor code	TAK-906
D.3.9.4	EV Substance Code	SUB195443
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	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	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.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	No
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	TAK-906
D.3.2	Product code	[TAK-906]
D.3.4	Pharmaceutical form	Capsule, hard
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	1352993-39-5
D.3.9.2	Current sponsor code	TAK-906
D.3.9.4	EV Substance Code	SUB195443
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	50
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Capsule, hard
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

Gastroparesis

Gastroparesi

E.1.1.1

Medical condition in easily understood language

Gastroparesis is a motility (movement) disorder of the stomach associated with slow or delayed emptying after meals.

La gastroparesi è un disturbo della motilità (movimento) dello stomaco associato a svuotamento lento o ritardato dopo i pasti.

E.1.1.2

Therapeutic area

Body processes [G] - Digestive System and Oral Physiological Phenomena [G10]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	PT
E.1.2	Classification code	10051153
E.1.2	Term	Diabetic gastroparesis
E.1.2	System Organ Class	10017947 - Gastrointestinal disorders

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10018043
E.1.2	Term	Gastroparesis
E.1.2	System Organ Class	10017947 - Gastrointestinal disorders

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	10021227
E.1.2	Term	Idiopathic gastroparesis
E.1.2	System Organ Class	10017947 - Gastrointestinal 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 assess the efficacy of treatment with various dose levels of TAK-906 in adult subjects with gastroparesis compared with placebo during 12 weeks of treatment.

Valutare l’efficacia del trattamento con diversi livelli di dosaggio di TAK-906 in soggetti adulti con gastroparesi rispetto al placebo nel corso di 12 settimane di trattamento

E.2.2

Secondary objectives of the trial

To evaluate the safety and tolerability of TAK-906 doses compared with placebo during 12 weeks of treatment

Additional Objectives:
To evaluate the pharmacokinetics of TAK-906 in subjects with gastroparesis
To evaluate the effect of TAK-906 on quality of life compared with placebo.
To evaluate the potential relationship between changes in C-reactive protein (CRP), glucose-dependent insulinotropic peptide (GIP), peptide tyrosine tyrosine (PYY), clinical symptoms and motility response
To evaluate the effect of TAK-906 on GEBT.

Valutare la sicurezza e la tollerabilità delle dosi di TAK-906 rispetto al placebo nel corso di 12 settimane di trattamento

Obiettivi aggiuntivi:
Valutare la farmacocinetica di TAK-906 in soggetti con gastroparesi.
Valutare l’effetto di TAK-906 sulla qualità della vita rispetto al placebo.
Valutare la potenziale relazione tra variazioni nei livelli di proteina C-reattiva (CRP), peptide insulinotropico glucosio-dipendente (GIP), peptide tirosina-tirosina (PYY), sintomi clinici e risposta di motilità.
Valutare l’effetto di TAK-906 sul GEBT.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Adult men and women aged 18 to 85 years, inclusive, and with body mass index =19 to =40 kg/m2 inclusive.
- Subjects should have symptoms of gastroparesis (eg, postprandial fullness, nausea, vomiting, upper abdominal pain, and early satiety) for
at least 3 months before Screening as assessed by a physician.
- Subjects must have an average composite ANMS GCSI-DD symptom score =2 during the 7 days before randomization. The predominant symptom experienced by subjects must not be abdominal pain.
- Subjects must experience nausea: nausea subscale (of ANMS GCSI-DD) symptom score =2 at least 4 of 7 days or an average nausea subscale symptom score =2 during the 7 days beforerandomization. Nausea symptoms must not be attributable to a central disorder (eg, motion sickness, glaucoma, menstrual cycles, migraine headache).
- Subjects must have confirmed delayed gastric emptying at Screening: delayed gastric emptying by GEBT,defined as time to gastric half
emptying (t1/2) =79 minutes (80th percentile).
- Absence of gastric outlet obstruction confirmed by upper GI, CT, or endoscopy.

Special Inclusion for Subjects with Diabetes Mellitus
- Subjects must have glycosylated hemoglobin (HbA1c) =11% before the Randomization Visit.

• Uomini e donne adulti di età compresa tra 18 e 85 anni, inclusi, e con indice di massa corporea da =19 a =40 kg/m2 inclusi.
• I soggetti devono presentare sintomi di gastroparesi (ad es. sazietà postprandiale, nausea, vomito, dolore al quadrante addominale superiore e sazietà precoce) per almeno 3 mesi prima dello screening, in base alla valutazione di un medico.
• I soggetti devono avere un punteggio medio composito dei sintomi valutati mediante l’ANMS GCSI-DD = durante i 7 giorni che precedono la randomizzazione. Il sintomo predominante manifestato dai soggetti non deve essere dolore addominale.
• I soggetti devono manifestare nausea: punteggio dei sintomi nella sottoscala nausea (dell’ANMS GCSI-DD) =2 almeno 4 giorni su 7 o un punteggio medio dei sintomi nella sottoscala nausea =2 durante i 7 giorni che precedono la randomizzazione. I sintomi della nausea non devono essere attribuibili a un disturbo centrale (ad es. chinetosi, glaucoma, cicli mestruali, mal di testa emicranico).
I soggetti devono presentare un ritardo nello svuotamento gastrico confermato allo screening: ritardo nello svuotamento gastrico in base al GEBT, definito come tempo necessario a raggiungere metà dello svuotamento gastrico (t1/2) =79 minuti (80° percentile).
• Assenza di ostruzione dell’efflusso gastrico confermata mediante esame diagnostico del tratto gastrointestinale (GI) superiore, tomografia computerizzata (TC) o endoscopia.

Inclusione specifica per i soggetti con diabete mellito
• I soggetti devono avere un livello di emoglobina glicosilata (HbA1c) =11% prima della visita di randomizzazione.

E.4

Principal exclusion criteria

- Known secondary causes of gastroparesis including but not limited to Parkinson disease, cancer, viral illness, or connective tissue diseases.
- Predominant gastroparetic symptom is epigastric pain, diffuse abdominal pain, or pain associated with bowel movement.
- Is taking medications that affect gastric emptying including opioids, glucagon-like peptide-1 analogs (eg,exenatide, liraglutide), amylin analogs (eg, pramlintide), and cannabinoids.
- Prior history of gastric surgery, including but not limited to gastrectomy, gastric bypass, gastric banding bariatric surgery pyloroplasty, vagotomy, or fundoplication, which has manipulated the natural anatomy of the stomach.
- History of intrapyloric botulinum toxin injection within 3 months of Screening or currently has a functioning implantable gastric electric stimulator.
- Nasogastric, percutaneous endoscopic gastrostomy, or percutaneous endoscopic jejunostomy feeding tube or inpatient hospitalization for gastroparesis within 2 weeks before the Screening Visit.
- Required parenteral nutrition for treatment of gastroparesis within 2 months before the Screening Visit.
- Previous diagnosis of gastric bezoar (the presence of retained liquid, bile, or small amounts of poorly organized food residue is permitted).
- Poor control of diabetes within 30 days before study entry, including diabetic ketoacidosis, hypoglycemia requiring medical intervention, admission for control of diabetes or diabetic complications.
- Elevated serum prolactin (>upper limit of normal [ULN]) at Screening. A high prolactin level at the Screening Visit that is considered to be due to stress of venipuncture, chest wall stimulation, or other physiological causes may be retested after a few days and if normal, the subjects may be enrolled in the study.
- Medical history of hypogonadism, current clinically significant menstrual abnormalities, or other clinical features of hyperprolactinemia will be excluded.
- Signs/symptoms of extrapyramidal system disease and other clinically relevant central nervous system or neuropsychiatric disease included but not limited to tardive dyskinesia, neuroleptic malignant syndrome, acute dystonia, parkinsonian like symptoms and severe depression.

• Cause secondarie di gastroparesi note, incluse, ma non limitate a, malattia di Parkinson, tumore, malattia virale o malattie del tessuto connettivo.
• Il sintomo gastroparetico predominante è dolore epigastrico, dolore addominale diffuso o dolore associato ai movimenti intestinali.
• Il soggetto sta assumendo farmaci che influenzano lo svuotamento gastrico, tra cui oppiacei, analoghi del peptide-1 glucagone-simile (ad es. exenatide, liraglutide), analoghi dell’amilina (ad es. pramlintide) e cannabinoidi.
• Precedente anamnesi di intervento chirurgico gastrico, inclusi ma non limitati a gastrectomia, bypass gastrico, bendaggio gastrico, chirurgia bariatrica, piloroplastica, vagotomia o fundoplicazione, che abbia alterato la naturale anatomia dello stomaco.
• Anamnesi di iniezione intrapilorica di tossina botulinica nei 3 mesi precedenti lo screening o presenza di uno stimolatore elettrico gastrico impiantabile attualmente in funzione.
• Gastrostomia endoscopica percutanea con sonda nasogastrica o digiunostomia endoscopica percutanea con sondino gastrico o ricovero ospedaliero per gastroparesi nelle 2 settimane precedenti la visita di screening.
• Necessità di nutrizione parenterale per il trattamento della gastroparesi entro 2 mesi precedenti la visita di screening.
• Precedente diagnosi di bezoario gastrico (è consentita la presenza di liquido trattenuto, bile o piccole quantità di residui alimentari scarsamente organizzati).
• Scarso controllo del diabete nei 30 giorni prima dell’ingresso nello studio, incluse chetoacidosi diabetica, ipoglicemia con necessità di intervento medico, ricovero per il controllo del diabete o complicanze diabetiche.
• Elevati livelli sierici di prolattina (>limite superiore della norma [ULN]) allo screening. Un alto livello di prolattina alla visita di screening, che sia ritenuto causato dallo stress della venipuntura, dalla stimolazione della parete toracica o da altre cause fisiologiche può essere rianalizzato dopo pochi giorni e, in caso di risultati nella norma, i soggetti potranno essere arruolati nello studio.
• Anamnesi medica di ipogonadismo, anomalie mestruali clinicamente significative in corso o altre caratteristiche cliniche di iperprolattinemia saranno escluse.
• Segni/Sintomi di malattia del sistema extrapiramidale e altre malattie del sistema nervoso centrale o neuropsichiatriche clinicamente rilevanti, comprese, ma non limitate a, discinesia tardiva, sindrome neurolettica maligna, distonia acuta, sintomi parkinsoniani e depressione grave.

E.5 End points

E.5.1

Primary end point(s)

Change from baseline to Week 12 of the Treatment Period in the ANMS GCSI-DD composite score (nausea, early satiety, upper abdominal pain, and postprandial fullness).

Variazione dal basale alla Settimana 12 del periodo di trattamento nel punteggio ANMS GCSI-DD composito (nausea, sazietà precoce, dolore al quadrante addominale superiore e sazietà postprandiale).

E.5.1.1

Timepoint(s) of evaluation of this end point

12 weeks

12 settimane

E.5.2

Secondary end point(s)

Proportion of subjects with at least 50% reduction from baseline in ANMS GCSI-DD composite score at Week 12.
Change from baseline to Week 12 of the treatment period in the ANMS GCSI-DD nausea symptom score.
Change from baseline to Week 12 of the treatment period in the ANMS GCSI-DD early satiety symptom score.
Change from baseline to Week 12 of the treatment period in the ANMS GCSI-DD postprandial fullness symptom score.
Change from baseline to Week 12 of the treatment period in the ANMS GCSI-DD upper abdominal pain symptom score.
Change from baseline to Week 12 of the treatment period in the ANMS GCSI-DD recorded vomiting frequency.
Change from baseline to Week 12 of the treatment period in the ANMS GCSI-DD overall severity of gastroparesis symptoms score.
Change from baseline to Week 12 of the treatment period in the bloating severity scale score.
Change from baseline to Week 12 of the treatment period in the ANMS GCSI-DD Total Score (nausea, early satiety, upper abdominal pain, postprandial fullness, bloating, and vomiting).
Proportion of symptomatic weeks (weeks with symptoms assessed as >mild [average ANMS GCSI-DD composite score =2]) during 12 weeks of treatment.
Change from baseline to Week 12 of the treatment period in the Patient Assessment of Upper Gastrointestinal Disorders-Symptom Severity Index (PAGI-SYM) total score.

• Percentuale di soggetti con una riduzione di almeno il 50% rispetto al basale nel punteggio ANMS GCSI-DD composito alla Settimana 12.
• Variazione dal basale alla Settimana 12 del periodo di trattamento nel punteggio dei sintomi della nausea valutati in base all’ANMS GCSI-DD.
• Variazione dal basale alla Settimana 12 del periodo di trattamento nel punteggio dei sintomi di sazietà precoce valutati in base all’ANMS GCSI-DD.
• Variazione dal basale alla Settimana 12 del periodo di trattamento nel punteggio dei sintomi di sazietà postprandiale valutati in base all’ ANMS GCSI-DD.
• Variazione dal basale alla Settimana 12 del periodo di trattamento nel punteggio dei sintomi del dolore al quadrante addominale superiorevalutati in base all’ANMS GCSI-DD.
• Variazione dal basale alla Settimana 12 del periodo di trattamento nella frequenza degli episodi di vomito registrati nell’ANMS GCSI-DD.
• Variazione dal basale alla Settimana 12 del periodo di trattamento nel punteggio relativo alla gravità complessiva dei sintomi gastroparetici valutati in base all’ANMS GCSI-DD.
• Variazione dal basale alla Settimana 12 del periodo di trattamento nel punteggio della scala di valutazione della gravità del gonfiore.
• Variazione dal basale alla Settimana 12 del periodo di trattamento nel punteggio ANMS GCSI-DD totale (nausea, sazietà precoce, dolore al quadrante addominale superiore, sazietà postprandiale, gonfiore e vomito).
• Percentuale di settimane sintomatiche (settimane con sintomi valutati come più che lievi [punteggio ANMS GCSI-DD medio composito =2]) durante le 12 settimane di trattamento.
• Variazione dal basale alla Settimana 12 del periodo di trattamento nel punteggio totale della Valutazione dei disturbi del tratto gastrointestinale superiore da parte del paziente-Indice di gravità dei sintomi (PAGI-SYM).

E.5.2.1

Timepoint(s) of evaluation of this end point

12 weeks

12 settimane

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

Yes

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

Yes

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

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

Information not present in EudraCT

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Belgium

Italy

Japan

Poland

United States

E.8.7

Trial has a data monitoring committee

Yes

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

LVLP

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:

250

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.4.2

For a multinational trial

F.4.2.1

In the EEA

F.4.2.2

In the whole clinical trial

280

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)

Study drug will not be available on completion of the subject’s participation in the study. The subject should be returned to the care of a physician and standard therapies as required

il farmaco dello studio non sarà disponibile dopo il completamento della partecipazione del soggetto allo studio. il soggetto dovrebbe tornare alle cure del medico e alle necessarie terapie standard.

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

2019-05-07

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2019-05-09

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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Orphan Designation Number:
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