Clinical Trials Register

Summary
EudraCT Number:	2017-002811-33
Sponsor's Protocol Code Number:	LAINCO1107
National Competent Authority:	Spain - AEMPS
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2017-10-10
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

Spain - AEMPS

A.2

EudraCT number

2017-002811-33

A.3

Full title of the trial

Unilateral, open and randomized phase IV study of 2 groups to assess the degree of comfort with simple Emuliquen® in patients undergoing proctological surgery

Estudio de fase IV, unicéntrico, abierto y aleatorizado de 2 grupos para evaluar el grado de confort con Emuliquen® simple en pacientes sometidos a cirugía proctológica

A.3.1

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

study to assess the degree of comfort with simple Emuliquen® in patients undergoing proctological surgery

ensayo para evaluar el grado de conford con Emuliquen Simple en pacientes sometidos a cirugía proctológica

A.3.2

Name or abbreviated title of the trial where available

LAINCO1107

A.4.1

Sponsor's protocol code number

LAINCO1107

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	LAINCO S.A
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	LAINCO S.A
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	Dynamic
B.5.2	Functional name of contact point	Teresa Pascual
B.5.3	Address:
B.5.3.1	Street Address	C/Azcona 31
B.5.3.2	Town/ city	Madrid
B.5.3.3	Post code	28028
B.5.3.4	Country	Spain
B.5.4	Telephone number	0000+ 34 91 456 11 0500
B.5.5	Fax number	0000+ 34 91 456 11 2600
B.5.6	E-mail	t.pascual@dynasolutions.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	Emuliquen
D.2.1.1.2	Name of the Marketing Authorisation holder	LAINCO S.A
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	EMULIQUEN
D.3.2	Product code	16678
D.3.4	Pharmaceutical form	Oral emulsion
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.3.9.2	Current sponsor code	16678
D.3.9.3	Other descriptive name	Emuliquen
D.3.9.4	EV Substance Code	SUB10569MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	500
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	Lactulosa Lainco
D.2.1.1.2	Name of the Marketing Authorisation holder	LAINCO S.A
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	Lactulosa Lainco
D.3.2	Product code	69299
D.3.4	Pharmaceutical form	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	LACTULOSE
D.3.9.1	CAS number	4618-18-2
D.3.9.2	Current sponsor code	69299
D.3.9.3	Other descriptive name	Lactulosa Lainco
D.3.9.4	EV Substance Code	SUB08386MIG
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
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

Surgery proctological

cirugía proctológica

E.1.1.1

Medical condition in easily understood language

Surgery proctological

cirugía proctológica

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10042759
E.1.2	Term	Symptoms involving digestive system
E.1.2	System Organ Class	100000016398

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 degree of comfort that patients experience after undergoing proctological surgery

Evaluar el grado de conford que experimentan los pacientes tras ser sometidos a cirugía proctológica

E.2.2

Secondary objectives of the trial

determine the degree of effort defecation
to evaluate the pain reliever in the act of defecation
to determine diarrhea processes
evaluate fecal impaction.
determine if there has been infection of the surgical wound

determinar el grado de esfuerzo defecatorio
evaluar el guardo de dolor en el acto defecatorio
determinar procesos de diarrea
evaluar la impactación fecal.
determinar si se ha producido infección de la herida quirúrgica

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients of both sex, between 18 and 75 years.
Patients who will be operated on for anorectal surgery, including hemorrhoids, fissure, anal fistula or benign anal canal polyps, regardless of the surgical technique to be used.
Patients who have given informed consent

Pacientes de ambos sexos, de entre 18 y 75 años.
Pacientes que van a ser intervenidos de cirugía ano-rectal, incluyendo hemorroides, fisura, fístula anal o pólipos canal anal benignos, independientemente de la técnica quirúrgica a utilizar.
Pacientes que hayan otorgado el consentimiento

E.4

Principal exclusion criteria

Cancer patient.
Patient with chronic functional constipation, according to Rome III criteria.
Patient with irritable bowel syndrome, according to Rome III criteria.
Woman of childbearing age with positive urine pregnancy test.
Patients who are participating in another clinical trial.

Paciente oncológico.
Paciente con estreñimiento funcional crónico, según criterios de Roma III.
Paciente con síndrome de intestino irritable, según criterios de Roma III.
Mujer en edad fértil con prueba de embarazo en orina positiva.
Pacientes que estén participando en otro ensayo clínico.

E.5 End points

E.5.1

Primary end point(s)

Percentage of patients who present intestinal colic and flatulence during treatment administration

Porcentaje de pacientes que presentan cólicos intestinales y flatulencias durante la administración del tratamiento

E.5.1.1

Timepoint(s) of evaluation of this end point

During 4-5 weeks

Durante 4-5 semanas

E.5.2

Secondary end point(s)

Degree of effort in defecation (using a scale of 0 = incontinence, 1 = slides, no effort, 2 = normal, 3 = a lot of pain) during treatment administration.
Degree of pain in defecation (using a visual analogue scale (EVA) of 0-10 cm, where 0 = no pain and 10 = maximum possible pain) during treatment administration.
Processes of diarrhea (according to the Bristol Stool Scale) during the treatment period.
Fecal impaction during the treatment period.
Infection of the wound during the treatment period.

Grado de esfuerzo en la defecación (mediante una escala de 0= incontinencia; 1= se desliza, ningún esfuerzo; 2= normal; 3= mucho dolor), durante la administración del tratamiento.
Grado de dolor en la defecación (mediante una escala visual analógica (EVA) de 0-10 cm, donde 0=sin dolor y 10=el máximo dolor posible), durante la administración del tratamiento.
Procesos de diarrea (según la Escala de heces de Bristol) durante el periodo de tratamiento.
Impactación fecal durante el periodo de tratamiento.
Infección de la herida durante el periodo de tratamiento.

E.5.2.1

Timepoint(s) of evaluation of this end point

during 4-5 weeks

Durante 4-5 semanas

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

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

E.8.1.1

Randomised

Yes

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

End of the trial is the last patient last vitis for last patient included on study

El fin del estudio se considerará la última visita del último paciente incluido en el estudio

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:

100

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

120

F.4.2

For a multinational trial

F.4.2.1

In the EEA

120

F.4.2.2

In the whole clinical trial

120

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)

Once the clinical trial is completed, the patients will continue to be followed according to the clinical practice of the center.

Una vez finalizado el ensayo clínico los pacientes continuarán en seguimiento según la práctica clínica del centro.

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

2017-12-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-11-24

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2021-04-20

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