Clinical Trials Register

Summary
EudraCT Number:	2011-004384-75
Sponsor's Protocol Code Number:	37970
National Competent Authority:	Netherlands - Competent Authority
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2012-09-10
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

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A. Protocol Information

A.1

Member State Concerned

Netherlands - Competent Authority

A.2

EudraCT number

2011-004384-75

A.3

Full title of the trial

Randomized controlled trial: Picoprep versus Moviprep for efficacy, safety and patient tolerability in colonoscopy bowel preparation.

Gerandomiseerd onderzoek naar de werkzaamheid, veiligheid en patienten acceptatie van Picoprep versus Movioprep bij de voorbereiding voor een coloscopie

A.3.1

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

Is Picoprep and Moviprep equally adequate, safe and tolerable in the adequate bowel cleansing for colonosocpy?

Is Picoprep en Moviprep even effectief, veilig en acceptabel bij de voorbereiding voor een coloscopie?

A.3.2

Name or abbreviated title of the trial where available

PicoMovi

A.4.1

Sponsor's protocol code number

37970

A.7

Trial is part of a Paediatric Investigation Plan

A.8

EMA Decision number of Paediatric Investigation Plan

B. Sponsor Information

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	picoprep
D.2.1.1.2	Name of the Marketing Authorisation holder	Ferring BV
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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	picoprep
D.3.2	Product code	RGV 106616
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.3.9.4	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.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	magnesium oxide
D.3.9.1	CAS number	3344-18-1
D.3.9.3	Other descriptive name	MAGNESIUM CITRATE
D.3.9.4	EV Substance Code	SUB14422MIG
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	anhydrous citric acid
D.3.9.1	CAS number	77-92-9
D.3.9.3	Other descriptive name	ANHYDROUS CITRIC ACID
D.3.9.4	EV Substance Code	SUB16203MIG
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	12
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	moviprep
D.2.1.1.2	Name of the Marketing Authorisation holder	Norgine
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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.3.2	Product code	RVG 34072
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.3.9.1	CAS number	8000014-43-9
D.3.9.3	Other descriptive name	MACROGOL 4000
D.3.9.4	EV Substance Code	SUB14400MIG
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.3.9.1	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	ASCORBIC ACID
D.3.9.1	CAS number	50-81-7
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	10,6
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 who need a colonoscopy for screening, surveillance or diagnosis of a disease have to be prepared by bowel cleansing

Patienten die een coloscopie moeten ondergaan vanwege screening, opvolging of diagnose van een ziekte moeten darmvoorbereiding krijgen

E.1.1.1

Medical condition in easily understood language

Polyp detection and removal, detection of large bowel cancer and diagnosis of defecation problems by colonoscopy after adequate bowel cleansing

Ontdekken en verwijderen van poliepen, opsporen van darmkanker en diagnose van defecatie klachten via colonoscopy na adequate darmvoorbereiding

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	LLT
E.1.2	Classification code	10010009
E.1.2	Term	Colonoscopy and sigmoidoscopy abnormal
E.1.2	System Organ Class	10022891 - Investigations

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	LLT
E.1.2	Classification code	10010010
E.1.2	Term	Colonoscopy and sigmoidoscopy normal
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

Colonoscopy is considered the reference standard for detection of colonic neoplasia. Polyp detection is dependent on quality standards including colonoscopist and patient related factors. Optimal bowel preparation is associated with lower polyp miss rates. Improving tolerability of bowel cleansing may encourage patient compliance. Lowering the intake of bowel preparation would increase patient tolerability. We hypothesize that the small dose Picoprep is as efficacious for bowel cleansing as small dose Moviprep (PEG) and that Picoprep is as safe as Moviprep and may be more tolerable for patients.

Coloscopie is de standaard voor de detectie van darmkanker en darmpoliepen. Het ontdekken van poliepen is afhankelijk van de ervaring van de endoscopist en de voorbereiding van de patient. Optimale darmvoorbereiding is geassocieerd met het minder missen van poliepen maar wel een belasting voor de patient. Vermindering van het in te nemen volume zal de patiententrouw doen toenemen.We veronderstellen dat een de verminderde dosering bij het gebruik van picoprep en moviprep dezelfde goede voorbereiding zal geven en dezlefde veiligheid, maar dat de kleinere dosis van picoprep de acceptatie van de patient zal vergroten.

E.2.2

Secondary objectives of the trial

Patient safety by blood sampling and telephone contact

Veiligheid voor de patient door afname van bloed en nabellen

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patient 18 years and older, who have to uindergo a colonoscopy and who are able to give their informed consent and are eligible to undergo bowel-cleansing

Patienten ouder dan 18 jaar bij wie een indicatie bestaat voor coloscopie en die in staat zijn hun informed consent te geven en die de darmvoorbereiding kunnen ondergaan

E.4

Principal exclusion criteria

Patients with significant gastroparesis or gastric outlet obstruction; ileus; known or suspected bowel obstruction or perforation; severe chronic renal failure (creatinine clearance < 30mL/minute); severe congestive heart failure (AHA class III or IV); toxic colitis or megacolon. Also, patients with a subtotal colectomy or a colostomy will be excluded because of insufficient remaining colonic surface to evaluate the effects of bowel cleansing.

Patienten met significant gastroparese of maaguitgangsstenose; ileus; bekende of vermoede darm obestructie of perforatie; ernstig nierlijden (kreatinine klaring < 30mL/minute); ernstig hartfalen (AHA classe III or IV); toxische colitis of megacolon. Patienten met een subtotale colectomie of een colostoma worden uitgesloten omdat er te weinig overblijvend darmoppervlakte is voor een effectieve beoordeling.

E.5 End points

E.5.1

Primary end point(s)

Preparation efficacy is evaluated by the blinded colonoscopist. Bowel preparation is assessed by the validated Ottawa Bowel Preparation Scale and the Boston Bowel Preparation Scale based on the preparation scores from three segments of the colon (right colon, transverse colon and left colon), as well as a score for overall colonic fluid. A questionnaire is used to assess tolerance of the bowel preparation. This questionnaire is will assess items as bloating, cramping, nausea and overall burden. All items are scored on a 5-point Likert scale.

De darmvoorberiding wordt blind door de endoscopist beoordeeld aan de hand van 2 gevalideerde vragenlijsten (Ottawa Bowel Preparation Scale and the Boston Bowel Preparation Scale) die de 3 segmenten van het colon (rechter, transversum en linker) colon scoren en een score geven voor de hoeveelheid vocht. tevens wordt met een vragenlijst de tolerantie van de darmvoorbereiding zoals opgeblazen gevoel, misselijkheid, braken, belasting inschatten op een 5-punts Likert schaal.

E.5.1.1

Timepoint(s) of evaluation of this end point

Endoscopist once after the colonoscopy, patient once after taking the preparation.

De endoscopist direct na de coloscopy, de patient na inname van de darmvoorbereiding

E.5.2

Secondary end point(s)

Adverse events will be recorded for 30 days after colonoscopy. Blood will be collected after the prep and right before the procedure to assess electrolyte shifts and tested for bicarbonate, blood urea nitrogen, calcium, chloride, creatinine, magnesium, phosphate, potassium, sodium, haemoglobin and hematocrite.

Compliacties worden gedurende 30 dagen na de coloscopie opgevolgd. Bloed wordt afgenomen voor de start en na het voltooien van de voorbereiding en onderzocht op bicarbonaat, ureum, calcium, chloor, kreatinine, magnesium, fosfaat, kalium, natrium, haemoglobine and hematocriet.

E.5.2.1

Timepoint(s) of evaluation of this end point

Blood sampling twice and a telephone call after 30 days

Tweemaal bloedafname en een telefonische afspraak na 30 dagen.

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

Yes

E.6.2

Prophylaxis

Yes

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

Yes

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

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

End of study by LVLS

Einde studie bij de laatste visite van laatste patient

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:

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

F.3.3.1

Women of childbearing potential not using contraception

F.3.3.2

Women of child-bearing potential using contraception

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

340

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)

Care for patients after the trial should be needed when an adverse event occurs. Electrolyte disturbances may tbe present in the worst case and will be coreected by intravenous fluids

Patienten die door de voorbereiding een stoornis in de electroliten krijgen zullen worden opgenomen om dit met een infuus te correigeren

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

2012-09-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-07-17

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

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