Clinical Trials Register

Summary
EudraCT Number:	2011-002364-25
Sponsor's Protocol Code Number:	NOR-01/2011(PDR)
National Competent Authority:	Germany - BfArM
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2011-08-05
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

Germany - BfArM

A.2

EudraCT number

2011-002364-25

A.3

Full title of the trial

A multi-centre, randomised, investigator-blinded study comparing the polyp detection rate of two different types of bowel preparation: a 2-litre solution (MOVIPREP®) versus a hyperosmotic and stimulant combined low volume bowel preparation (Sodium Picosulfate and Magnesium Citrate)

A.3.1

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

A study to compare the polyp (tissue mass in the gut) detection rate after bowel cleansing using 2 different types of preparation

A.3.2

Name or abbreviated title of the trial where available

MOVIPREP versus Sodium Picosulfate & Magnesium Citrate in polyp detection

A.4.1

Sponsor's protocol code number

NOR-01/2011(PDR)

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	Norgine Limited
B.1.3.4	Country	United Kingdom
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	Norgine Limited
B.4.2	Country	United Kingdom
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Pierrel Research Europe GmbH
B.5.2	Functional name of contact point	CRO
B.5.3	Address:
B.5.3.1	Street Address	Zeche Katharina 6
B.5.3.2	Town/ city	Essen
B.5.3.3	Post code	45307
B.5.3.4	Country	Germany
B.5.4	Telephone number	004920189900
B.5.5	Fax number	00492018990201
B.5.6	E-mail	office.europe@pierrel-research.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	MOVIPREP
D.2.1.1.2	Name of the Marketing Authorisation holder	Norgine BV
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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	MOVIPREP
D.3.4	Pharmaceutical form	Powder for oral solution
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	Macrogols
D.3.9.1	CAS number	25322-68-3
D.3.9.3	Other descriptive name	Polyethylene glycol
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	100
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	SODIUM SULPHATE
D.3.9.1	CAS number	7757-82-6
D.3.9.3	Other descriptive name	SODIUM SULPHATE, ANHYDROUS
D.3.9.4	EV Substance Code	SUB12308MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	7.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Potassium Chloride
D.3.9.1	CAS number	7447-40-7
D.3.9.3	Other descriptive name	POTASSIUM CHLORIDE
D.3.9.4	EV Substance Code	SUB12559MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1.015
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Sodium Ascorbate
D.3.9.1	CAS number	134-03-02
D.3.9.3	Other descriptive name	Sodium Ascorbate
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4.7
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Sodium Chloride
D.3.9.1	CAS number	7646-14-5
D.3.9.3	Other descriptive name	Sodium Chloride
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	2.691
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ASCORBIC ACID
D.3.9.1	CAS number	50-81-7
D.3.9.3	Other descriptive name	ASCORBIC ACID
D.3.9.4	EV Substance Code	SUB05579MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	4.7
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	Comparator
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
D.2.1.1.2	Name of the Marketing Authorisation holder	E.C De Witt & Company Limited
D.2.1.2	Country which granted the Marketing Authorisation	Germany
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
D.3.4	Pharmaceutical form	Powder for oral solution
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.3.9.3	Other descriptive name	SODIUM PICOSULPHATE
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	10.0
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	light MAGNESIUM OXIDE
D.3.9.1	CAS number	546-93-0
D.3.9.3	Other descriptive name	MAGNESIUM OXIDE, LIGHT
D.3.9.4	EV Substance Code	SUB12130MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	3.5
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CITRIC ACID ANHYDROUS
D.3.9.1	CAS number	77-92-9
D.3.9.3	Other descriptive name	CITRIC ACID, ANHYDROUS
D.3.9.4	EV Substance Code	SUB11826MIG
D.3.10	Strength
D.3.10.1	Concentration unit	g gram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	10.97
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

Patients with clinical symptoms or polyp history scheduled for either a diagnostic/surveillance colonoscopy or for a screening procedure in patients with a personal or familial risk of colon neoplasia.

E.1.1.1

Medical condition in easily understood language

Colonoscopy investigation for colon cancer.

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	15.0
E.1.2	Level	PT
E.1.2	Classification code	10010007
E.1.2	Term	Colonoscopy
E.1.2	System Organ Class	10022891 - Investigations

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 compare the polyp and adenoma detection rate of MOVIPREP® versus an oral Sodium Picosulfate/Magnesium Citrate solution

E.2.2

Secondary objectives of the trial

To assess the correlation between the cleansing quality and the detection rate of the two types of bowel cleansing preparations.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Inclusion Criteria:
• Patient’s written informed consent must be obtained prior to inclusion
• Male or female outpatients or inpatients aged 40 to 80 years with an indication for complete colonoscopy
•Willing to undergo a colonoscopy for diagnostic or surveillance purposes
•Patients with a known personal of familial risk of colon neoplasia, willing to undergo a screening colonoscopy
• Willing, able and competent to complete the entire procedure and to comply with study instructions
• Females of childbearing potential must employ an adequate method of contraception

E.4

Principal exclusion criteria

Exclusion Criteria:
Patients will not be eligible to take part in the study if:
• History of gastric emptying disorders.
• History of ileus, toxic megacolon, gastrointestinal obstruction and colonic perforation.
• History of phenylketonuria.
• Known glucose-6-phosphate dehydrogenase deficiency.
• Known hypersensitivity to macrogol 3350, sodium sulphate or ascorbic acid/sodium ascorbate.
• History of colonic resection.
• Requirement for permanent medication and associated stable serum concentrations (e.g. neuroleptic drugs).
• Presence of congestive heart failure (NYHA III + IV).
• Acute life-threatening cardiovascular disease.
• Documented history of severe renal insufficiency (creatinine clearance <30 ml/min).
• Other contraindication described in the summary of product characteristics (SmPC) of either preparation.
• Patient has a condition, clinically significant laboratory results, or is in a situation which, in the investigator’s opinion, may put the patient at significant risk, may confound the study results, or may interfere significantly.
• Application of any unlicensed medication within the previous 3 months or participation in any other research study in the last 3 months.
• Females who are pregnant, nursing or planning a pregnancy.
• Patients who, in the opinion of the investigator, may not be compliant with the study requirements.
• Previous participation in this clinical study.

E.5 End points

E.5.1

Primary end point(s)

Polyp detection rate (PDR,) defined as number of patients with at least one polyp or flat lesion as recorded by the endoscopist.

E.5.1.1

Timepoint(s) of evaluation of this end point

Complete enrollment of 400 patients for interim analysis (IA) and subsequent enrollment of up to 800 patients dependent on the outcome of the IA.

E.5.2

Secondary end point(s)

• Adenoma detection rate (ADR) defined as number of patients with at least one adenoma as confirmed by the pathologist
• ADR and PDR by location:
• left-sided (rectum, colon sigmoideum, colon descendens, left half of colon transversum)
• right-sided (right half of colon transversum, colon ascendens, caecum)
• Cancer detection rate, defined as number of patients with at least one malignancy in relation to total analysis population.
• Flat lesion only detection rate.
• Advanced risk lesion detection rate.
• Colonoscopy completion rate.
• Colon cleansing quality, as reported by the gastroenterologist, according to the Harefield Cleansing Scale©.
• Acceptability and tolerability of the study medication.

E.5.2.1

Timepoint(s) of evaluation of this end point

Complete enrollment of 400 patients for interim analysis (IA) and subsequent enrollment of up to 800 patients dependent on the outcome of the IA.

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

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

Yes

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)

Yes

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

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.8.6 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

Past 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

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:

800

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

800

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 return to standard of care treatment with their physician.

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

2011-08-31

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-10-31

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2012-12-18

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