Clinical Trials Register

Summary
EudraCT Number:	2017-002679-25
Sponsor's Protocol Code Number:	S60420
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2017-07-04
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

Expand All Collapse All

A. Protocol Information

A.1

Member State Concerned

Belgium - FPS Health-DGM

A.2

EudraCT number

2017-002679-25

A.3

Full title of the trial

Characterization of colonic motility patterns in different functional bowel disorders compared to health and their role in moving content

Karakteriseren van colon motor patronen in verschillende functionele darmziekten in vergelijking met gezonden en hun rol in het voortbewegen van inhoud

A.3.1

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

Describing movements of the large bowel in different bowel disorders in comparison to health and their role in moving bowel content

Beschrijven van bewegingen die de dikke darm maakt in verschillende darmziekten in vergelijking met gezonden en hun rol in het voorbewegen van de darminhoud

A.4.1

Sponsor's protocol code number

S60420

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	KU Leuven
B.1.3.4	Country	Belgium
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	KU Leuven
B.4.2	Country	Belgium
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	KU Leuven
B.5.2	Functional name of contact point	Jasper Pannemans; Sub Investigator
B.5.3	Address:
B.5.3.1	Street Address	Herestraat 49
B.5.3.2	Town/ city	Leuven
B.5.3.3	Post code	3000
B.5.3.4	Country	Belgium
B.5.4	Telephone number	+32 16322794
B.5.6	E-mail	jasper.pannemans@kuleuven.be

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	Bisacodyl
D.2.1.1.2	Name of the Marketing Authorisation holder	Boehringer Ingelheim
D.2.1.2	Country which granted the Marketing Authorisation	Belgium
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	Bisacodyl
D.3.4	Pharmaceutical form	Tablet
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intestinal use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Bisacodyl 5mg
D.3.9.1	CAS number	603-50-9
D.3.9.3	Other descriptive name	BISACODYL
D.3.9.4	EV Substance Code	SUB05846MIG
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

Functional bowel disorders; irritable bowel syndrome (constipation, diarrhea and mixed), chronic constipation, and chronic diarrhea.

Functionele darmziekten; prikkelbare darmsyndroom (constipatie, diarree en gemengd subtype), chronische constipatie en chronische diarree

E.1.1.1

Medical condition in easily understood language

Bowel disorders in which there is a disturbance in the function.

Stoornissen van het darmstelsel waarbij er problemen zijn met de functie.

E.1.1.2

Therapeutic area

Diseases [C] - Digestive System Diseases [C06]

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

Clarify whether FBD-type related differences in motor pattern occurrence and aspects (amplitude in mmHg, duration in seconds, simultaneous or propagating, with direction and extent in centimeters, velocity in centimeters /second and colonic site of origin) can explain disease presentation, and give insight in disease pathophysiology.

Meer inzicht verkrijgen in de FBD-type gerelateerde verschillende in motor patroon voorkomen en aspecten (amplitude in mmHG, duur in seconden, simultane or propagerende patronen, met richting en uitbreiding in centimeters, voortgeleiding in centimeters/seconden en oorsprong in het colon) meer inzicht kan geven in ziektepresentatie en pathofysiologie.

E.2.2

Secondary objectives of the trial

Linking colonic motor patterns to propagation of content using colonic intraluminal impedance monitoring.

Het verbinden van colon motorpatronen aan de voortgeleiding van de inhoud met behulp van de intraluminale impedantie monitoring in het colon.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patient is a man or woman aged 18 to 80 years, inclusive, at prescreening.
2. Patient has a diagnosis of a functional bowel disorder according to the Rome IV criteria.
3. Patient needs a colonoscopy for diagnostic reasons, for risk factors (age above 50 years of age), or because of occurrence of alarm features (weight loss within the past 6 months; family history of colorectal cancer or IBD; blood loss with their stool, not convincingly due to hemorrhoids or fissure).
4. Patient has not used any loperamide rescue medication within 2 days prior to randomization.
5. Patient has not used any opioid medication to reduce their pain within 14 days prior to randomization
6. Patients on stable doses of antidepressants (ie, for the 3 months prior to prescreening) will be allowed to participate in the study. Medications taken for the treatment of allergies, chronic medical conditions, and migraine headaches can be taken during this study (with the exception of opioids for acute treatment of migraines). Patient must be on a stable dose of medication for chronic migraines or preventative therapy for at least 1 month at prescreening. As needed use of benzodiazepines, if habitual, is permitted.
7. Female patients must be:
a. postmenopausal, defined as 52 years or older and amenorrheic for at least 2 years at prescreening,
b. surgically sterile (have had a hysterectomy or bilateral oophorectomy, tubal ligation, or otherwise be incapable of pregnancy),
c. abstinent, or
d. if sexually active, be practicing an effective method of birth control such as hormonal prescription oral contraceptives, progesterone implants or injections, contraceptive patch, intrauterine device, or male partner with a vasectomy.
8. Patient must sign an informed consent document before the initiation of any study-related procedures indicating that he or she understands the purpose of and procedures required for the study and is willing to participate in the study.

1. Patient is een man of vrouw, tussen de 18 - 80 bij prescreening.
2. Patient heeft een diagnose van functionele darmziekten op basis van de Rome IV criteria.
3. Patient heeft een coloscopie nodig, voor diagnostische redenen, voor risicofactoren, of vanwege het voorkomen van alarmsymptomen.
4. Patient heeft geen loperamide gebruikt 2 dagen voor coloscopie.
5. Patient heeft geen opiaten genomen 14 dagen voor het onderzoek.
6. Patienten die een stabiel dosis antidepressiva gebruiken worden toegelaten te participeren. Medicatiegebruik voor de behandeling van allergieen, chronische medische condities en migraine mogen gebruikt worden tijdens deze studie. Benzodiazepinen gebruik, wanneer gebruikelijk, is toegestaan.
7. Vrouwelijke patienten moeten:
a. postmenopauzaal zijn, gedefinieerd als 52 jaar of ouder en een ammenoroeduur van tenminste 2 jaar bijprescreening.
b. chirurgisch gesteriliseerd zijn
c. abstineren
d. wanneer seksueel actief zijn, gebruik maken van effectieve anticonceptie.
8. Patienten moeten een informed consent tekenen alvorens ze mogen deelnemen aan de studie.

E.4

Principal exclusion criteria

1. History of inflammatory or immune-mediated GI disorders including inflammatory bowel disease (ie, Crohn’s disease, ulcerative colitis) and celiac disease.
2. History of diverticulitis
3. History of intestinal obstruction, stricture, toxic megacolon, GI perforation, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation (eg, aortoiliac disease).
4. Patient has any of the following surgical history:
a. Any abdominal surgery within the 3 months prior to prescreening;
b. Patient has a history of major gastric, hepatic, pancreatic, or intestinal surgery (appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post-surgery are allowed).
5. History or current evidence of laxative abuse.
6. Patient has a history of a cardiovascular event, including stroke, myocardial infarction, congestive heart failure, or transient ischemic attack within 6 months prior to prescreening.
7. Patient has an unstable renal, hepatic, metabolic, or hematologic condition.
8. Patient has a history of malignancy within 5 years before prescreening (except squamous and basal cell carcinomas and cervical carcinoma in situ).
9. Patient has abnormal thyroid function test as confirmed by thyroid-stimulating hormone <0.3 mcIU/mL or ≥5 mcIU/mL at Prescreening. However, patients who are clinically euthyroid due to thyroid supplement are candidates for the study.
10. Patient has current (within 14 days of randomization) or expected use of any narcotic or opioid containing agents, docusate, enemas, GI preparations (including antacids containing aluminum or magnesium, antidiarrheal agents, antinausea agents, antispasmodic agents, bismuth, or prokinetic agents).
11. Patient is pregnant or breastfeeding.
12. Patient has any condition that, in the opinion of the investigator, would compromise the well-being of the patient or the study or prevent the patient from meeting or performing study requirements.

1. Voorgeschiedenis van inflammatoire darmziekten of immuun gemedieerde gastrointestinale aandoeningen als inflammatoire darmziekten en Coeliakie.
2. Voorschiedenis van diverticulitis.
3. Voorgeschiedenis van intestinale obstructie, strictuur, toxisch megacolon, darmperforatie, maagband, bariatrische heelkunde, adhesies, ischemische colitis of verminderde darmdoorbloeding.
4. Patient heeft een van de volgende chirurgische precedenten:
a. Enige abdominale heelkunde binnen 3 maanden voor de prescreening
b. Patient heeft een voorgeschiedenis van grote maag, lever, pancreas, of darmheelkunde.
5. Voorgeschiedenis of huidig bewijs van laxeermiddelenmisbruik.
6. Patient heeft een voorgeschiedenis van cardiovasculaire events binnen 6 maanden van prescreening.
7. Patient heeft een onstabiele nier-, lever-, metabole functie of hematologische conditie.
8. Patient heeft een voorgeschiedenis met maligniteit binnen 5 jaar voor prescreening.
9. Patient heeft een abnormale schildklierfunctie. Patienten die euthyroid zijn door gebruik te maken van supplementen worden toegelaten.
10. Patient heeft huidig of verwacht gebruik van enig narcotisch or opiaatbevattend middel, natriumdioctylsulfosuccinaat, klysma's, preparaten die alluminium, magnesium, antidiarree middelen, antimisselijkheidsmiddelen, antispastische middelen, bismuth of prokinetica bevatten.
11. Patient is zwanger of geeft borstvoeding.
12. Patient heeft een conditie die volgens de investigator het welzijn van de patient comprimeert of voorkomt dat de patient voldoet aan de voorwaarden om de studie te voltooien.

E.5 End points

E.5.1

Primary end point(s)

Evaluation of the motor patterns characteristics and the discrepancy in occurrence of sequences in FBDs versus health and between separate FBDs.

Evaluatie van de motorische patroon karakteristieken en de discrepantie in het voorkomen van sequenties in functionele darmziekten t.o.v. gezonde vrijwilligers en tussen de verschillende functionele darmziekten.

E.5.1.1

Timepoint(s) of evaluation of this end point

After the single colonic manometry

Na de enkele colonmanometrie

E.5.2

Secondary end point(s)

- Description of the relationship between colonic motor patterns and propulsion.
- Description of the relationship between colonic motor patterns and symptoms.

- Beschrijving van de relatie tussen colon motor patronen en propulsie.
- Beschrijving van de relatie tussen colon motor patronen en symptomen.

E.5.2.1

Timepoint(s) of evaluation of this end point

After the single colonic manometry

Na de enkele colonmanometrie

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

E.6.3

Therapy

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

Yes

E.6.13.1

Other scope of the trial description

Pathophysiologic

Pathofysiologisch

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.8.3

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

The trial is finished when we have included the total amount of patients. Subjects will not be required to come back for another visit. This study only requires one visit to the hospital.

Het onderzoek is afgelopen wanneer we het totale gewenste aantal patienten hebben geincludeerd. Patienten hoeven niet terug te komen voor een bezoek. Er is slechts 1 bezoek aan het ziekenhuis noodzakelijk.

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)

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)

None

Geen

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

2017-07-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-09-12

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

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