Clinical Trials Register

Summary
EudraCT Number:	2011-000670-62
Sponsor's Protocol Code Number:	M0001-C401(SPD555-C401)
National Competent Authority:	Belgium - FPS Health-DGM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-04-05
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

Belgium - FPS Health-DGM

A.2

EudraCT number

2011-000670-62

A.3

Full title of the trial

A randomised, double-blind, placebo-controlled trial to evaluate the efficacy, quality of life, safety and tolerability of long-term treatment (24 weeks) with prucalopride in subjects aged ≥18 years with chronic constipation.

A.3.1

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

A study to evaluate the potency, quality of life, side effects and tolerability of long-term treatment (24 weeks) with prucalopride in patients aged ≥18 years with chronic constipation.

A.4.1

Sponsor's protocol code number

M0001-C401(SPD555-C401)

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	Shire-Movetis NV
B.1.3.4	Country	Belgium
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	Shire-Movetis NV
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	Shire-Movetis NV
B.5.2	Functional name of contact point	Shire-Movetis Clinical Trials
B.5.3	Address:
B.5.3.1	Street Address	Veedijk 58
B.5.3.2	Town/ city	Turnhout
B.5.3.3	Post code	2300
B.5.3.4	Country	Belgium
B.5.4	Telephone number	+3214404390
B.5.5	Fax number	+32 14404391
B.5.6	E-mail	Shire-Movetis.clinicaltrials@shire.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	Resolor®
D.2.1.1.2	Name of the Marketing Authorisation holder	Shire-Movetis NV
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Resolor
D.3.2	Product code	M0001
D.3.4	Pharmaceutical form	Film-coated 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	Prucalopride
D.3.9.1	CAS number	179474818
D.3.9.2	Current sponsor code	M0001
D.3.9.3	Other descriptive name	PRUCALOPRIDE SUCCINATE
D.3.9.4	EV Substance Code	SUB28850
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	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.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	Resolor®
D.2.1.1.2	Name of the Marketing Authorisation holder	Shire-Movetis NV
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Resolor
D.3.2	Product code	M0001
D.3.4	Pharmaceutical form	Film-coated 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	Prucalopride
D.3.9.1	CAS number	179474818
D.3.9.2	Current sponsor code	M0001
D.3.9.3	Other descriptive name	PRUCALOPRIDE SUCCINATE
D.3.9.4	EV Substance Code	SUB28850
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	1
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	Coated tablet
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

Chronic constipation

E.1.1.1

Medical condition in easily understood language

Chronic constipation

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	14.1
E.1.2	Level	PT
E.1.2	Classification code	10010774
E.1.2	Term	Constipation
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 evaluate the long-term (24 weeks) efficacy of prucalopride versus placebo in subjects aged 18 years and older with chronic constipation.

E.2.2

Secondary objectives of the trial

To evaluate the long-term safety, tolerability and the effect on quality of life of prucalopride versus placebo in subjects aged 18 years and older with chronic constipation.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Main inclusion criteria to be assessed at screening:
1. Subject is a male or non-pregnant, non-breastfeeding female out-patient ≥18 years of age (no upper age limit).
2. Subject has a history of constipation. The subject reports an average of ≤2 SBM/week that result in a feeling of complete evacuation (SCBM) and one or more of the following for at least 6 months before the selection visit:
a) Very hard (little balls) and/or hard stools at least a quarter of the
stools;
b) Sensation of incomplete evacuation following at least a quarter of
the stools;
c) Straining at defecation at least a quarter of the time.
The above criteria are only applicable for SBMs, i.e. BMs not preceded
within a period of 24 hours by the intake of a laxative agent or by the use of an enema.
Subjects who never have SBMs are considered to be constipated and are eligible for the trial.
3. Subject agrees to stop his/her current laxative treatment and is willing to use rescue medication according to the rescue rule [bisacodyl (Dulcolax®)/enemas]

Main inclusion criteria to be assessed at randomisation:
1. During the run-in phase the subject reports an average of ≤2 SBM/week that result in a feeling of complete evacuation (SCBM).
2. Subject stopped his/her laxative treatment and did not use rescue mediation on more than 75% of days during the run-in phase.
3. Subject did not use disallowed medication during the run-in phase.

E.4

Principal exclusion criteria

Main exclusion criteria to be assessed at screening:
1. Subjects in whom constipation is thought to be drug-induced
2. Subjects using any disallowed medication.
3. Subjects who previously used prucalopride.
4. Subjects suffering from secondary causes of chronic constipation

E.5 End points

E.5.1

Primary end point(s)

The primary endpoint is defined as the proportion (%) of subjects with an average of ≥3 SCBM/week evaluated over the 24-week treatment phase.

E.5.1.1

Timepoint(s) of evaluation of this end point

The key evaluation period will be the 24-week double-blind
treatment phase. This endpoint will also be evaluated in periods of 4 weeks and per week of treatment.

E.5.2

Secondary end point(s)

A:
- The proportion of subjects with an average increase of ≥1 SCBM/week.
- The average number of (SC)BM/week and change from baseline.
- The number of (SC)BMs per week: descriptive statistics and distribution in categories as 0, (0;1),[1;2),[2;3),[3;->).
- Consistency per (SC)BM: descriptive statistics of 7-point score and
% (SC)BM with normal consistency (Type 3 or 4 on the Bristol stool scale) and % (SC)BM with hard/very hard consistency (Type 1 or 2 on the Bristol stool scale).
- Straining per (SC)BM: descriptive statistics of 5-point score and %
(SC)BM with no straining and with severe/very severe straining.
- Sensation of complete evacuation per (S)BM: % (S)BM with sensation of complete evacuation.
- Average time to first (SC)BM after the first intake of the trial medication (Day 1) and on Day 28 (Week 4).
- Average number of bisacodyl (Dulcolax®) tablets taken per week and the number of days with bisacodyl (Dulcolax®) use per week.

B:
- Subject’s global assessment on severity of constipation (5-point scales; 0=none, 4=very severe).
- Subject’s global assessment on efficacy of treatment (5-point scales;
0=none, 4=extremely effective).
- Subject’s lower gastrointestinal symptom assessment by the PAC-SYM total score, subscale scores (stool symptoms, abdominal symptoms and rectal symptoms) and individual item scores (5 point scales; 0=none, 4=very severe).

Quality of life data measured at scheduled visits will be analysed by each scheduled visit and at endpoint. For all scores, summary statistics, will be provided as well as tabulations showing the percentage of subjects with an average improvement of ≥ 1 point.

E.5.2.1

Timepoint(s) of evaluation of this end point

Secondary parameters in category A will be derived from the e-diary and evaluated over the 24-week treatment period as well as after 4 weeks of treatment and per week of treatment.

Secondary parameters in category B will be summarised per scheduled visits and endpoint (last observation carried forward, LOCF), for both observed values and changes from baseline.

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

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

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

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

last patient last visit

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

F. Population of Trial Subjects
F.1 Age Range
F.1.1	Trial has subjects under 18	No
F.1.1.1	In Utero	No
F.1.1.2	Preterm newborn infants (up to gestational age < 37 weeks)	No
F.1.1.3	Newborns (0-27 days)	No
F.1.1.4	Infants and toddlers (28 days-23 months)	No
F.1.1.5	Children (2-11years)	No
F.1.1.6	Adolescents (12-17 years)	No
F.1.2	Adults (18-64 years)	Yes
F.1.2.1	Number of subjects for this age range:	295
F.1.3	Elderly (>=65 years)	Yes
F.1.3.1	Number of subjects for this age range:	65
F.2 Gender
F.2.1	Female	Yes
F.2.2	Male	Yes
F.3 Group of trial subjects
F.3.1	Healthy volunteers	No
F.3.2	Patients	Yes
F.3.3	Specific vulnerable populations	Yes
F.3.3.1	Women of childbearing potential not using contraception	No
F.3.3.2	Women of child-bearing potential using contraception	Yes
F.3.3.3	Pregnant women	No
F.3.3.4	Nursing women	No
F.3.3.5	Emergency situation	No
F.3.3.6	Subjects incapable of giving consent personally	No
F.3.3.7	Others	No
F.4 Planned number of subjects to be included
F.4.1	In the member state	20
F.4.2	For a multinational trial
F.4.2.1	In the EEA	360
F.4.2.2	In the whole clinical trial	360

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

2011-05-02

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-05-26

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-12-19

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