Clinical Trials Register

Summary
EudraCT Number:	2021-000985-14
Sponsor's Protocol Code Number:	VICAPEND
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2025-01-16
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

Spain - AEMPS

A.2

EudraCT number

2021-000985-14

A.3

Full title of the trial

Valuation of visualization quality of mucous membrane and diagnostic yield of small bowel capsule endoscopy using different bowel preparations clinical trial

Ensayo clínico sobre la valoración en la calidad de visualización de la mucosa y el rendimiento diagnóstico en la cápsula endoscópica de intestino delgado usando diferentes protocolos de preparación

A.3.1

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

Valuation of visualization quality of mucous membrane and diagnostic yield of small bowel capsule endoscopy using different bowel preparations clinical trial

A.4.1

Sponsor's protocol code number

VICAPEND

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	Universitary Hospital Príncipe de Asturias
B.1.3.4	Country	Spain
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	Hospital Universitario Príncipe de Asturias
B.4.2	Country	Spain
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Hospital Universitario Príncipe de Asturias
B.5.2	Functional name of contact point	Clinical Trial Information
B.5.3	Address:
B.5.3.1	Street Address	Carretera Alcalá-Meco, s/n
B.5.3.2	Town/ city	Alcalá de Henares
B.5.3.3	Post code	28805
B.5.3.4	Country	Spain
B.5.4	Telephone number	+349188781002610
B.5.6	E-mail	manisamed@hotmail.com

D. IMP Identification
D.IMP: 1
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	Aero-red 100 mg/ml gotas orales en solución
D.2.1.1.2	Name of the Marketing Authorisation holder	URIACH CONSUMER HEALTHCARE, S.L.
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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	Aero-red 100 mg/ml gotas orales en solución
D.3.2	Product code	39560
D.3.4	Pharmaceutical form	Solution for use in drinking water/milk
D.3.4.1	Specific paediatric formulation	Yes
D.3.7	Routes of administration for this IMP	Oral use
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 polvo para solución oral
D.2.1.1.2	Name of the Marketing Authorisation holder	Norgine BV
D.2.1.2	Country which granted the Marketing Authorisation	Spain
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 polvo para solución oral
D.3.2	Product code	68125
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.3.11 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	Oral solution
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

Obscure gastrointestinal bleeding.
Inflammatory bowel disease as Crohn's disease.
Tumors of the small intestine.
Hereditary polyposis syndrome (familial adenomatous polyposis or Peutz-Jeghers Syndrome).
Celiac disease.
Intestinal lymphoma.
Chronic abdominal pain with other symptoms associated and elevated calprotectin >100-150 mcg.

Hemorragia digestiva de origen oscuro
Enfermedad inflamatoria intestinal tipo Crohn
Tumores del intestino delgado
Síndromes de poliposis hereditarios (Poliposis adenomatosa familiar o el síndrome de Peutz Jeghers)
Enfermedad celiaca.
Linfoma intestinal.
Otras indicaciones menos frecuentes como el dolor abdominal crónico con otros síntomas asociados y calprotectina elevada >100-150 mcg

E.1.1.1

Medical condition in easily understood language

Obscure gastrointestinal bleeding.
Crohn's disease.
Tumors of the small intestine.
Celiac disease.
Intestinal lymphoma.
Chronic abdominal pain and elevated calprotectin >100-150 mcg.

Hemorragia digestiva de origen oscuro
Enfermedad tipo Crohn
Tumores del intestino
Enfermedad celiaca
Linfoma intestinal
Dolor abdominal crónico y calprotectina elevada >100-150 mcg

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10078598
E.1.2	Term	Small bowel capsule endoscopy
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 evaluate and to compare degree of cleanliness and visualization of small bowel mucosal in patients who have been treated with small bowel capsule endoscopy. This comparison will be done among three groups of bowel preparations:
• Clear liquid diet in previous day of the exam and fasting as only intervention.
• Clear liquid diet and two litres of polyethylene glycol in previous day of the exam and fasting
• Clear liquid diet in previous day of the exam and fasting associated to 2mL (200mg) of simeticone 15 minutes before the exploration.

Evaluar y comparar el grado de limpieza y visualización de la mucosa del intestino delgado en pacientes a los que se les realiza una cápsula endoscópica. La comparación se realizará entre los siguientes grupos de preparación:
• Dieta líquida el día anterior del examen y ayuno como única preparación.
• Dieta líquida y dos litros de polietilenglicol el día anterior al examen y ayuno.
• Dieta líquida el día anterior del examen, ayuno asociado a la administración de 2 ml (200 mg) de simeticona 15 minutos antes de la exploración.

E.2.2

Secondary objectives of the trial

• To establish if the findings of significant clinical injuries (diagnostic yield) of small bowel capsule endoscopy is increased due to the preparation use.
• To quantify gastric transit time among different preparations.
• To quantify small bowel transit time among different preparations.
• To evaluate the tolerability and acceptation of different preparations by patients.
• To quantify the percentage of completed studies.

• Establecer si el hallazgo de lesiones clínicamente significativas (rendimiento diagnóstico) en la cápsula endoscópica se ve incrementado con el uso de la preparación.
• Cuantificar el tiempo de tránsito gástrico (TTG) en las distintas pautas de preparación.
• Cuantificar el tiempo de tránsito del intestino delgado (TTID) en las distintas pautas de preparación.
• Investigar la tolerabilidad y aceptación por parte del paciente a las distintas preparaciones.
• Cuantificar el porcentaje de estudios completados.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

• Patients older than 18 years old who have been prescribed a study of small bowel through capsule endoscopy and its cause is encompassed in habitual clinical practice.
• Signed informed consent form for the study with capsule endoscopy.
• Signed informed consent form for the inclusion in the clinical trial.

• Pacientes mayores o igual a 18 años a quienes se les indique la realización de un estudio de intestino delgado a través de cápsula endoscópica y cuya indicación se encuentre englobada en la práctica clínica habitual.
• Aportarán consentimiento informado firmado para la realización de cápsula endoscópica.
• Aportar consentimiento informado firmado y fechado para la entrada en el ensayo clínico.

E.4

Principal exclusion criteria

• Suspicion or diagnosis of intestinal obstruction/perforation.
• Small bowel stenosis.
• Serious gastroparesis.
• Is a study with Patency® capsule has been previously done: retention or expulsion of deform capsule
• Pregnant women.
• Patients with serious hepatic or cardiovascular or renal disease where use of Moviprep® is contraindicated.
• Patients with adverse drug reactions or allergies of polyethylene glycol or simeticone.

• Sospecha o diagnóstico de obstrucción / perforación gastrointestinal.
• Estenosis de intestino delgado conocidas.
• Pacientes con gastroparesia severa
• En caso de realización de cápsula Patency® previa: Retención o expulsión deformada de la misma.
• Embarazadas
• Pacientes que presenten enfermedad hepática, cardiovascular o renal graves que contraindiquen la preparación con polietilenglicol (Movipep®).
• Pacientes que presenten o hayan presentado alguna reacción adversa o alergia al polietinenglicol (Moviprep ®) o a la simeticona.

E.5 End points

E.5.1

Primary end point(s)

Degree of cleanliness of small bowel using an accepted cleanliness scale.

Grado de limpieza del intestino delgado utilizando una escala de limpieza aceptada.

E.5.1.1

Timepoint(s) of evaluation of this end point

During the endoscopy.

Durante la endoscopia.

E.5.2

Secondary end point(s)

• diagnostic yield of small bowel capsule endoscopy
• Gastric transit time
• Small bowel transit time
• Tolerability of preparation
• Percentage of completed studies

o rendimiento diagnóstico de la cápsula endoscópica
o Tiempo de tránsito gástrico (TTG)
o Tiempo de tránsito del intestino delgado (TTID)
o Tolerabilidad de la preparación
o Porcentaje de estudios completos

E.5.2.1

Timepoint(s) of evaluation of this end point

During the endoscopy.

Durante la endoscopia.

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

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

E.8.1.5

Parallel group

E.8.1.6

Cross over

E.8.1.7

Other

Yes

E.8.1.7.1

Other trial design description

Abierto de evaluación ciega

Open and blind evaluation

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

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

Última visita del último paciente

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

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

172

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

Ninguno

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

2021-03-23

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2021-03-23

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

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