Clinical Trials Register

Summary
EudraCT Number:	2014-003043-35
Sponsor's Protocol Code Number:	2014/01
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:	2014-12-29
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

2014-003043-35

A.3

Full title of the trial

Infiltration of bupivacaine and triamcinolone at Milligan-Morgan hemorrhoidectomy surgical site to manage postoperative pain

Infiltración de bupivacaina y triamcinolona en la hemorroidectomía de Milligan y Morgan para el control del dolor post-operatorio

A.3.1

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

Injection of bupivacaine and triamcinolone in the surgical treatment of hemorrhoids to manage postoperative pain

Inyección de bupivacaina y triamcinolona en la cirugía de las hemorroides para controlar el dolor post-quirúrgico

A.3.2

Name or abbreviated title of the trial where available

Bupivacaine and triamcinolone in hemorrhoidectomy surgery

Bupivacaina y triamcinolona en la cirugía hemorroidal

A.4.1

Sponsor's protocol code number

2014/01

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	Hospital General de Vic
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 General de Vic
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 General de Vic
B.5.2	Functional name of contact point	Pere Roura-Poch
B.5.3	Address:
B.5.3.1	Street Address	1, Francesc Pla
B.5.3.2	Town/ city	Vic, Barcelona
B.5.3.3	Post code	08500
B.5.3.4	Country	Spain
B.5.4	Telephone number	34937027713
B.5.5	Fax number	34938850308
B.5.6	E-mail	proura@chv.cat

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	INIBSACAIN HIPERBARICA0.5% solución inyectable
D.2.1.1.2	Name of the Marketing Authorisation holder	INIBSA HOSPITAL, SLU
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	Bupivacaina
D.3.2	Product code	3349
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	Epilesional use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	BUPIVACAINE
D.3.9.1	CAS number	2180-92-9
D.3.9.4	EV Substance Code	SUB05983MIG
D.3.10	Strength
D.3.10.1	Concentration unit	ml millilitre(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	5
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	Yes
D.3.11.13.1	Other medicinal product type	Local anesthetic
D.IMP: 2
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	TRIGON DEPOT
D.2.1.1.2	Name of the Marketing Authorisation holder	Bristol-Myers Squibb, SA
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	TRIGON DEPOT 40 mg/ml suspensión inyectable
D.3.2	Product code	LMH
D.3.4	Pharmaceutical form	Concentrate and solvent for suspension for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Epilesional use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	TRIAMCINOLONE ACETONIDE
D.3.9.1	CAS number	76-25-5
D.3.9.4	EV Substance Code	SUB04936MIG
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	40
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 suffering hemorrhoids which are diagnosed as grade III or IV and proposed to surgical treatment by a Milligan and Morgan procedure

Pacientes diagnosticados de hemorroides de grado III o IV propuestos para tratamiento quirúrgico mediante la técnica de Milligan y Morgan

E.1.1.1

Medical condition in easily understood language

Patients suffering hemorrhoids which are diagnosed as grade III or IV and proposed to surgical treatment by a Milligan and Morgan procedure

Pacientes diagnosticados de hemorroides de grado III o IV propuestos para tratamiento quirúrgico mediante la técnica de Milligan y Morgan

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Surgical Procedures, Operative [E04]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	18.0
E.1.2	Level	LLT
E.1.2	Classification code	10019611
E.1.2	Term	Hemorrhoids
E.1.2	System Organ Class	100000004856

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Management and control of post-surgical pain in Milligan and Morgan surgical procedure to treat grade III and IV hemorrhoids

Control del dolor post-operatorio en la técnica de Milligan y Morgan para el tratamiento quirúrgico de las hemorroides de grado III y IV.

E.2.2

Secondary objectives of the trial

Analyze the use of analgesia, the length of hospital stay, immediate postoperative complications such as bleeding, and time to heal.

Analizar el consumo de analgesia, la duración de la estancia hospitalaria, la aparición de complicaciones postoperatorias inmediatas como el sangrado, y tiempo de cicatrización.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Patients suffering hemorrhoids which are diagnosed as grade III or IV and proposed to surgical treatment by a Milligan and Morgan procedure

Pacientes diagnosticados de hemorroides de grado III o IV propuestos para tratamiento quirúrgico mediante la técnica de Milligan y Morgan

E.4

Principal exclusion criteria

Patients with relapse of their hemorrhoidal disease,
Patients proposed for reoperation,
Second time hemorrhoidectomies,
Rubber band hemorrhoidectomy,
Hemorrhoidectomy with Longo technique,
Patients with anal fistula, anal fissure or anal polyp,
Patients for surgical revision of the anal canal for proctalgia or anusalgia,
Patients with neuropathy,
Patients with bleeding disorder,
Patients with known allergies to medications used (anesthetics and analgesics) and
Patients with chronic opioid therapy and chronic treatment with corticosteroids.

Pacientes con reacaída de su enfermedad hemorroidal,
Pacientes propuestos para reintervención,
Hemorroidectomías en segundo tiempo,
Hemorroidectomía con banda elástica,
Hemorroidectomía con la técnica de Longo,
Pacientes con fístula anal, fisura anal o pólipo anal,
Pacientes para revisión quirúrgica del canal anal por proctalgia o anusalgia,
Pacientes con neuropatía,
Pacientes con trastorno de la coagulación,
Pacientes con alergias conocidas a los medicamentos utilizados (anestésicos y analgésicos) y
Pacientes con tratamiento crónico con opiáceos y corticoides.

E.5 End points

E.5.1

Primary end point(s)

Level of pain at several time-points during hospital stay

Nivel de dolor en distintos momentos de la estancia hospitalaria

E.5.1.1

Timepoint(s) of evaluation of this end point

On first 24 hours, at 1, 6, 12, 18 and 24 hours and from 25 hours to 4 days 3 times a day. At each of these time-points we collect the level of pain by the means an analogic visual scale (from zero to ten points) and with a verbal scale (no pain, mild, moderate, severe).

En las primeras 24 horas, a la hora, a las 6, 12 y 24 horas y desde las 25 horas hasta el cuarto día de hospitalización tres veces al día. En cada uno de estos momentos se obtendrá el nivel de dolor mediante una escala visual analógica (de cero a 10) y mediante una escala verbal (sin dolor, leve, moderado, severo, insoportable)

E.5.2

Secondary end point(s)

Drug administration under analgesia protocol and needs of rescue.

Administración de medicamentos de acuerdo con el protocolo de analgesia y necesidades de rescate

E.5.2.1

Timepoint(s) of evaluation of this end point

When analgesia will be administered under clinical guidelines and the date and hour when a rescue would be be administered (drug and dose), if needed.

Cuando proceda administrar la analgesia según el protocolo y el día y la hora que se administre el medicamento (y la dosis) de rescate cuando se necesite.

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

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

Yes

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)

E.8.2.2

Placebo

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

La práctica clínica habitual no incluye ningun tratamiento local para el control del dolor

Usual clinical practice doesn't include any epilesional drug administration to control local pain

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

Yes

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

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:

110

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

Yes

F.3.3.1

Women of childbearing potential not using contraception For clinical trials recorded in the database before the 10th March 2011 this question read: "Women of childbearing potential" and did not include the words "not using contraception". An answer of yes could have included women of child bearing potential whether or not they would be using contraception. The answer should therefore be understood in that context. This trial was recorded in the database on 2014-12-29.

Yes

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

140

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

2015-03-30

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2014-10-02

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

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