Clinical Trials Register

Summary
EudraCT Number:	2015-003740-39
Sponsor's Protocol Code Number:	URO-CHUAC-BPSat-001.
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:	2016-02-24
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

2015-003740-39

A.3

Full title of the trial

Open randomized clinical trial to examine individual pain tolerance in the use of two anesthetic techniques to perform saturation prostate biopsy .

Ensayo clínico aleatorizado abierto para analizar la tolerancia individual al dolor en el empleo de dos técnicas anestésicas para la realización de la biopsia de próstata de saturación.

A.3.1

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

Open randomized clinical trial to examine individual pain tolerance in the use of two anesthetic techniques to perform extended prostate biopsy .

Ensayo clínico aleatorizado abierto para analizar la tolerancia individual al dolor en el empleo de dos técnicas anestésicas para la realización de la biopsia de próstata más ampliada.

A.3.2

Name or abbreviated title of the trial where available

URO ? CHUAC ? BPSat ? 001.

A.4.1

Sponsor's protocol code number

URO-CHUAC-BPSat-001.

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	Jose Luis Ponce Díaz-Reixa
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	Complexo Hospitalario Universitario de A Coruña
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	Jose Luis Ponce Díaz-Reixa
B.5.2	Functional name of contact point	Jose Luis Ponce Díaz-Reixa
B.5.3	Address:
B.5.3.1	Street Address	As Xubias 84 - Servicio de Urología - Planta 11
B.5.3.2	Town/ city	A Coruña
B.5.3.3	Post code	15006
B.5.3.4	Country	Spain
B.5.4	Telephone number	34981178057
B.5.5	Fax number	34981176380
B.5.6	E-mail	Jose.Luis.Ponce.Diaz-Reixa@sergas.es

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	MIDAZOLAM GENFARMA 15 mg/3 ml solucio?n inyectable
D.2.1.1.2	Name of the Marketing Authorisation holder	GENFARMA LABORATORIO, 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.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous bolus use (Noncurrent)
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	FENTANEST 0,05 mg/ml solucion inyectable
D.2.1.1.2	Name of the Marketing Authorisation holder	Kern Pharma, 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.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous bolus use (Noncurrent)
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: 3
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	KETOLAR 50 mg/ml solucio?n inyectable
D.2.1.1.2	Name of the Marketing Authorisation holder	Parke-Davis, 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.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous bolus use (Noncurrent)
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: 4
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	Mepivacai?na Inyectable Braun 2% Miniplasco
D.2.1.1.2	Name of the Marketing Authorisation holder	B.BRAUN MEDICAL 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.3.4	Pharmaceutical form	Solution for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intraprostatic 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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Prostate biopsy anesthesia

Anestesia en la biopsia de próstata

E.1.1.1

Medical condition in easily understood language

Procedure to remove pain during prostate sampling.

Procedimiento para quitar el dolor durante la toma de muestras de la próstata

E.1.1.2

Therapeutic area

Diseases [C] - Male diseases of the urinary and reproductive systems [C12]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.1
E.1.2	Level	LLT
E.1.2	Classification code	10004825
E.1.2	Term	Biopsy of prostate
E.1.2	System Organ Class	100000004848

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 assess the effectiveness of two anesthetic techniques by measuring the pain through visual analog scale (VAS ), to obtain saturation prostate biopsies .

Valorar la efectividad de dos técnicas anestésicas mediante la medición del dolor a través de la escala visual analógica (EVA), para la obtención de biopsias de próstata de saturación.

E.2.2

Secondary objectives of the trial

To assess the safety of the procedure and complications in the use of each of the anesthetic techniques during saturation prostate biopsy

Valorar la seguridad del procedimiento y complicaciones en el uso de cada una de las técnicas anestésicas de la biopsia de próstata de saturación

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

-Male patient
-Persistence of suspected prostate cancer by altering the prostatic specific antigen and / or digital rectal examination.
-Two previous negative prostate biopsies .
-Age < 75 years.
-Signature of informed consent to perform prostate biopsy.
-Signature of informed consent for the study.
-Pre-anesthetic consultation to all patients

-Paciente varón
-Persistencia de sospecha de cáncer de próstata por alteración del antígeno específico prostático y/o tacto rectal.
-Dos biopsias de próstata previas negativas.
-Edad < 75 años.
-Firma del consentimiento informado para la realización de la biopsia de próstata.
-Firma del consentimiento informado del paciente para la realización del estudio.
-Consulta preanestésica a todos los pacientes

E.4

Principal exclusion criteria

-Age > 75 years.
-Absence of consent or refusal to the study .
-Presence of prostate cancer in previous biopsy observation .
-Medical-surgical patient's problems, absolutely contraindicating biopsy under local anesthesia.
-Presence of any allergies to medications involved in the study .
-Patient's clinical situation that does not allow an outpatient operation and aftercare required .
-Medical condition of the patient, preventing the realization of outpatient biopsy.
-No companion.

-Edad > 75 años.
-Ausencia de consentimiento o rechazo para la realización del estudio.
-Presencia de carcinoma prostático en observación en biopsia previa.
-Problemas médico-quirúrgicos del paciente, que contraindiquen de manera absoluta la biopsia con anestesia local.
-Presencia de algún tipo de alergia a medicamentos implicados en el estudio.
-Situación clínica del paciente que no permita un manejo ambulatorio y precise vigilancia postoperatoria.
-Problema médico del paciente, que impide la realización de biopsia ambulatoria.
-Ausencia de acompañante.

E.5 End points

E.5.1

Primary end point(s)

To determinate a difference in pain of 1.4 ± 2.5 on the visual analog scale (pain under sedation 0.5 vs. 1.9 with locoregional), with 80 % power and 95 % confidence .

Determinar una diferencia de dolor de 1,4±2,5 en la escala visual analógica (dolor con sedación 0,5 vs. 1,9 con locorregional), con un 80% de poder estadístico y 95% de seguridad.

E.5.1.1

Timepoint(s) of evaluation of this end point

Basal time: Pain at baseline , before any anesthetic procedure or urological manipulation. Scale of 0-10 .
End time: Pain after the procedure, the patient leaving the operating room. Scale of 0-10 .

Tiempo basal: Dolor en estado basal, antes de iniciar cualquier procedimiento anestésico o manipulación urológica. Escala de 0 a 10.
Tiempo final: Dolor después del procedimiento, al salir el enfermo del quirófano. Escala de 0 a 10.

E.5.2

Secondary end point(s)

- Presence of medication side effects of the procedure : nausea or vomiting , hypotension or hypertension and / or bradycardia or tachycardia .
- Presence of secondary complications to the procedure : hematuria , urinary difficulty, urinary retention, urinary tract infection and / or sepsis . The use of additional pain medication in the post- procedure is also measured.

- Presencia de efectos secundarios a la medicación del procedimiento: náuseas o vómitos, hipotensión o hipertensión y/o bradicardia o taquicardia.
- Presencia de complicaciones, secundarias al procedimiento: hematuria, dificultad miccional, retención urinaria, infección del tracto urinario y/o sepsis urinaria. Se medirá también el uso de medicación analgésica adicional en el post-procedimiento.

E.5.2.1

Timepoint(s) of evaluation of this end point

Time interval between final procedure and 24 hours after the procedure.

Intervalo de tiempo entre el procedimiento y las 24 últimas horas después del procedimiento

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

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

LVLS

Última visita del último sujeto reclutado.

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

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