Clinical Trials Register

Summary
EudraCT Number:	2011-006331-35
Sponsor's Protocol Code Number:	PT-SM-10
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2012-12-13
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

Italy - Italian Medicines Agency

A.2

EudraCT number

2011-006331-35

A.3

Full title of the trial

Efficacy and safety of long term local anaesthetic intralesional infusion in patients with mammary carcinoma undergoing mastectomy with breast reconstruction: a randomized, double-blind study.

EFFICACIA E SICUREZZA DELL'INFUSIONE INTRALESIONALE A LUNGO TERMINE DI ANESTETICO LOCALE IN PAZIENTI AFFETTE DA CARCINOMA MAMMARIO SOTTOPOSTE A MASTECTOMIA CON RICOSTRUZIONE PROTESICA IMMEDIATA: STUDIO RANDOMIZZATO IN DOPPIO CIECO

A.3.1

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

Efficacy and safety of long term wound catheter infusion in patients undergoing mastectomy associated to breast reconstruction: a randomized, double-blind study.

Efficacia e sicurezza dell’infusione di anestetico locale nella ferita chirurgica tramite un catetere appositamente studiato in pazienti affette da carcinoma mammario che vengono sottoposte a intervento chirurgico di mastectomia con ricostruzione immediata tramite protesi

A.3.2

Name or abbreviated title of the trial where available

PT-SM-10-Breast- Long lasting WI - BLLWI

A.4.1

Sponsor's protocol code number

PT-SM-10

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	OSPEDALE POLICLINICO S. MATTEO
B.1.3.4	Country	Italy
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	Fondazione IRCCS Policlinico San Matteo, Pavia
B.4.2	Country	Italy
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Fondazione IRCCS Policlinico San Matteo
B.5.2	Functional name of contact point	Struttura di Terapia del Dolore
B.5.3	Address:
B.5.3.1	Street Address	P.le Golgi 19
B.5.3.2	Town/ city	Pavia
B.5.3.3	Post code	27100
B.5.3.4	Country	Italy
B.5.4	Telephone number	0382502627
B.5.5	Fax number	0382502226
B.5.6	E-mail	terapia.dolore@smatteo.pv.it

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	CHIROCAINE*5F10ML 2,5MG/ML PPS
D.2.1.1.2	Name of the Marketing Authorisation holder	ABBOTT Srl
D.2.1.2	Country which granted the Marketing Authorisation	Italy
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	Concentrate for solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intralesional use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	LEVOBUPIVACAINE HYDROCHLORIDE
D.3.9.1	CAS number	27262-48-2
D.3.9.4	EV Substance Code	SUB02904MIG
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	2.5
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	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	Solution for injection
D.8.4	Route of administration of the placebo	Intralesional use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Post operative pain syndromes

Dolore acuto postoperatorio

E.1.1.1

Medical condition in easily understood language

Post operative pain syndromes which may result in the risk for chronic pain.

Dolore acuto postoperatorio moderato-severo, fattore di rischio per lo sviluppo di dolore cronico.

E.1.1.2

Therapeutic area

Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Anesthesia and Analgesia [E03]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.1
E.1.2	Level	PT
E.1.2	Classification code	10026878
E.1.2	Term	Mastectomy
E.1.2	System Organ Class	10042613 - Surgical and medical procedures

E.1.3

Condition being studied is a rare disease

E.2 Objective of the trial

E.2.1

Main objective of the trial

Verify if long term (14 days) local anesthetics infusion into the wound has a greater analgesic efficacy then placebo, assessed as reduction of opioid consumption and reduction of Numeric Rate Scale (NRS).

Verificare se l’infusione di anestetico locale a livello dell’incisione chirurgica abbia una maggiore efficacia analgesica del placebo nei primi 14 giorni dopo l’intervento, valutata tramite riduzione del consumo di farmaci analgesici (dose media di farmaco analgesico, associazione tramadolo+paracetamolo, necessaria per mantenere NRS<4 nei 14 giorni successivi all’intervento).

E.2.2

Secondary objectives of the trial

Verifiy if the active treatment is able to determine:
- Reduction of persistent pain (PMPS) incidence;
- Reduction of side effects;
- Reduction of surgical complication incidence;
- Better functional recovery;
- Quality of life improvement and early return to social life;

Dimostrazione nel gruppo di pazienti riceventi infusione di anestetico locale di:
- Riduzione del dolore nei 14 giorni seguenti l’intervento chirurgico;
- Riduzione dell’incidenza di effetti collaterali;
- Riduzione dell’incidenza di complicanze chirurgiche (infezione della ferita, deiscenza dei lembi, linfedema omolaterale dell’arto superiore, ecc);
- Migliore recupero funzionale dell’arto superiore;
- Miglioramento della qualità di vita e ripresa precoce delle attività socio-affettive;
- Riduzione dell’incidenza di dolore persistente.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- Females 18-70 years
- Classificazione American Society of Anesthesiologists (ASA) I,II
- Patients affected by infiltrant breast cancer or in situ cancer (DIN 2 and 3, or LIN 2 and 3 by Tavassoli) scheduled for mastectomy (nipple-sparing, skin-sparing, skin-reducing), sentinel node biopsy and/or anxillary lymoph node dissection and breast reconstruction
- Written informed consent

- Soggetti di sesso femminile di età superiore a 18 anni e inferiore a 70 anni;
- Classificazione American Society of Anesthesiologists (ASA) I e II;
- Affette da carcinoma mammario infiltrante o da carcinoma in situ candidabili per stadio locale della malattia a mastectomia con conservazione del complesso areola-capezzolo (nipple-sparing), mastectomia semplice con asportazione del complesso areola-capezzolo, mastectomia skin-sparing, mastectomia skin-reducing con lembo dermo-adiposo, con biopsia del linfonodo sentinella e/o dissezione ascellare;
- Esecuzione di ricostruzione protesica immediata sotto il muscolo pettorale;
- Consenso informato firmato

E.4

Principal exclusion criteria

- Preoperative chest or arm pain
- Use of analgesic drugs before surgery
- Alcol/drug addiction
- Emergency/urgency surgery
- Postoperative admission in an intensive care unit
- Cognitive impairment or mental retardation
- Severe hepatic (INR>2 and/or cholinestarasis < 2000) or renal impairment (Creatiniemia > 2 gr/dL)
- Cardiac disease
- Neurologic or psychiatric disease;
- Coagulation disorders (INR > 1.3, PTT > 44 sec)
- PTLs <100.000/mm3
- BMI > 30
- Allergy to one of the specific drugs under study

- Dolore in regione pettorale/ascellare/toracica omolaterale al momento del reclutamento;
- Assunzione di analgesici oppioidi in forma abituale;
- Storia di abuso di sostanze stupefacenti e/o alcolici;
- Ricovero postoperatorio in terapia intensiva, con sedazione e/o ventilazione meccanica;
- Insufficienza renale severa (creatinina > 2 g/dl, clearance creatinina < 30 ml/h) e/o epatica severa (colinesterasi < 2000 UI);
- Patologie cardiache (aritmie, insufficienza cardiaca);
- Patologie neurologiche (epilessia);
- Alterazioni cognitive, ritardo mentale, disturbi psichiatrici;
- Alterazioni dei valori normali della coagulazione o coagulopatie (INR > 2, PTT > 44 sec);
- Piastrinemia inferiore a 100.000/mm3;
- BMI > 30;
- Allergie ai farmaci in studio.

E.5 End points

E.5.1

Primary end point(s)

Reduction of at least 50% of the area under the analgesic drugs consumption-time curve in the period between the 2nd and the 14th postoperative day

Riduzione di almeno il 50% della area sotto la curva (AUC) del consumo medio di analgesico sistemico (tramadolo+paracetamolo) nel periodo compreso tra il 2° giorno postoperatorio e il 14° giorno

E.5.1.1

Timepoint(s) of evaluation of this end point

14th post operative day

Al 14° giorno post-operatorio

E.5.2

Secondary end point(s)

See secondary objective

Vedi obiettivi secondari

E.5.2.1

Timepoint(s) of evaluation of this end point

14th post operative day

Al 14° giorno post-operatorio

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

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

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

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.8.4.1

Number of sites anticipated in 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

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

Number of subjects for this age range:

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

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 2012-12-13.

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

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)

Non applicabile

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

2013-02-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-11-26

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

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