Clinical Trials Register

Summary
EudraCT Number:	2018-003257-16
Sponsor's Protocol Code Number:	CitraFleet_H-2018
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2018-09-26
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

Hungary - National Institute of Pharmacy

A.2

EudraCT number

2018-003257-16

A.3

Full title of the trial

Efficacy, Safety and Tolerability of CitraFleet, a New Bowel Cleansing Agent – a Prospective, Single-Center, Single-Group Phase IV Study

Az újonnan forgalomba került CitraFleet béltisztító készítmény hatékonyságának, biztonságosságának és tolerabilitásának vizsgálata - egy prospektív, egy-csoportos, egy vizsgálóhelyen végzett fázis IV. klinikai vizsgálat

A.3.1

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

Efficacy, Safety and Tolerability of CitraFleet, a New Bowel Cleansing Agent – a Prospective, Single-Center, Single-Group Phase IV Study

A.4.1

Sponsor's protocol code number

CitraFleet_H-2018

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	Goodwill Pharma Kft.
B.1.3.4	Country	Hungary
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	Goodwill Pharma Kft.
B.4.2	Country	Hungary
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Goodwill Pharma Kft
B.5.2	Functional name of contact point	DQPPV
B.5.3	Address:
B.5.3.1	Street Address	Cserzy M. u. 32.
B.5.3.2	Town/ city	Szeged
B.5.3.3	Post code	H-6724
B.5.3.4	Country	Hungary
B.5.4	Telephone number	36704522104
B.5.6	E-mail	janoska.zsolt@goodwillpharma.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	Yes
D.2.1.1.1	Trade name	Citrafleet por belsőleges oldathoz
D.2.1.1.2	Name of the Marketing Authorisation holder	Casen Recordati S.L.
D.2.1.2	Country which granted the Marketing Authorisation	Hungary
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	CitraFleet por belsőleges oldathoz
D.3.4	Pharmaceutical form	Powder for oral solution in sachet
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	SODIUM PICOSULFATE
D.3.9.1	CAS number	10040-45-6
D.3.9.4	EV Substance Code	SUB10569MIG
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	10
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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Colonoscopy bowel preparation

Kolonoszkópia előkészítés

E.1.1.1

Medical condition in easily understood language

Colonoscopy bowel preparation

Kolonoszkópia előkészítés

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Diagnosis [E01]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	20.1
E.1.2	Level	HLT
E.1.2	Classification code	10017963
E.1.2	Term	Gastrointestinal and abdominal imaging procedures
E.1.2	System Organ Class	100000004848

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 measure efficacy of CitraFleet by using Boston Bowel Preparation Scale.

A CitraFleet hatékonyságának mérése a Boston Béltisztasági Skála (Boston Bowel Preparation Scale) használatával.

E.2.2

Secondary objectives of the trial

• To measure safety of CitraFleet.
• To determine patient’s opinion about the tolerability and other qualities: taste, possible side effects (excessive thirst, nausea, vomiting, bloating, abdominal pain and cramps, headache, dizziness, sleep disturbance) of CitraFleet.

• A CitraFleet biztonságosságának mérése.
• A betegek véleményének felmérése a CitraFleet tolerabilitásával és egyéb tulajdonságaival kapcsolatban, mint az íz és a lehetséges mellékhatások (túlzott szomjúság, hányinger, puffadás, hasi fájdalom és görcsök, fejfájás, szédülés, alvási zavarok)

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. age between 18 and 80 years
2. patients scheduled to undergo colonoscopy at Endoscopy Unit of First Department of Internal Medicine at University of Szeged.
3. signed Informed Consent Form

1. 18 és 80 év közötti életkor
2. A beteg előjegyzése kolonoszkópiás vizsgálatra a Szegedi Tudományegyetem I. sz. Belgyógyászati Klinikáján
3. Aláírt Betegtájékoztató és Beleegyező nyilatkozat

E.4

Principal exclusion criteria

1. chronic kidney disease,
2. severe heart failure (New York Heart Association [NYHA] class III or IV),
3. uncontrolled hypertension (systolic pressure ≥170 mm Hg, diastolic pressure ≥100 mm Hg),
4. severe constipation,
5. any bowel resection,
6. significant gastroparesis, or suspected bowel obstruction or perforation,
7. hypersensitivity to the active substances or to any of the excipients,
8. severe dehydration,
9. hypermagnesaemia,
10. gastric retention,
11. gastro-intestinal ulceration,
12. toxic colitis, toxic megacolon,
13. ascites,
14. acute surgical abdominal conditions such as acute appendicitis and known or suspected gastro-intestinal obstruction or perforation,
15. active inflammatory bowel disease,
16. rhabdomyolysis,
17. pregnancy or lactation.

1. Krónikus vesebetegség,
2. Súlyos szívelégtelenség (New York Heart Association [NYHA] besorolása szerinti III. vagy IV. stádium),
3. Kezeletlen magasvérnyomás betegség (≥170 Hgmm szisztolés nyomás, ≥100 Hgmm diasztolés nyomás),
4. Súlyos székrekedés,
5. Bélreszekció,
6. Jelentős gastroparesis, bélelzáródás vagy perforáció gyanúja,
7. Túlérzékenység a vizsgálati készítmény hatóanyagával vagy valamely segédanyagával szemben,
8. Súlyos kiszáradás,
9. Hipermagnesaemia,
10. Gyomorürülési zavar,
11. Gastrointestinális fekélyképződés,
12. Toxikus vastagbélgyulladás, toxikus megacolon,
13. Ascites,
14. Akut sebészi intervenciót szükségessé tevő hasi kórkép, mint akut vakbélgyulladás és ismert vagy feltételezett gyomor-bélelzáródás vagy perforáció,
15. Aktív gyulladásos bélbetegség,
16. Rhabdomyolisis,
17. Terhesség vagy szoptatás.

E.5 End points

E.5.1

Primary end point(s)

The efficacy of CitraFleet will be measured using the Boston Bowel Preparation Scale by the ratio of patients achieving appropriate cleaning.

A CitraFleet hatékonyságát a Boston Béltisztasági Skála (Boston Bowel Preparation Scale) használatával mérjük a megfelelő béltisztítást elért betegek arányában.

E.5.1.1

Timepoint(s) of evaluation of this end point

Colonscopy

Kolonoszkópia

E.5.2

Secondary end point(s)

- To assess the safety of CitraFleet serum parameters (Na, K, UN and creatinine) will be assessed before and after the cleansing.
- To determine patient’s opinion about the tolerability and other qualities: taste, possible side effects (excessive thirst, nausea, vomiting, bloating, abdominal pain and cramps, headache, dizziness, sleep disturbance) of CitraFleet a patient reported questionnaire will be used.

-• A CitraFleet biztonságosságának megítéléséhez a szérum nátrium, kálium, karbamid és kreatinin meghatározása céljából vérmintát veszünk a béltisztítás előtt, valamint azt követően.
• A betegek véleményének felmérésére a CitraFleet tolerabilitásával és egyéb tulajdonságaival kapcsolatban, mint az íz és a lehetséges mellékhatások (túlzott szomjúság, hányinger, hányás, puffadás, hasi fájdalom és görcsök, fejfájás, szédülés, alvási zavarok) a beteg által kitöltött kérdőív szolgál majd.

E.5.2.1

Timepoint(s) of evaluation of this end point

- Laboratory parameters will be assessed before and after cleansing
- Patient tolerability questionnaire will be completed by the patient once after cleansing.

- A laboratóriumi paramétereket a béltisztítás előtt és után értékeljük
- A beteg tolerabilitási kérdőívet a betegek a béltisztítást követően egyszer töltik ki.

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)

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

E.8.1.1

Randomised

E.8.1.2

Open

Yes

E.8.1.3

Single blind

E.8.1.4

Double blind

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

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

utolsó beteg utolsó vizitje

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

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

F.3.3.1

Women of childbearing potential not using contraception