Clinical Trials Register

Summary
EudraCT Number:	2012-001557-46
Sponsor's Protocol Code Number:	01
National Competent Authority:	Denmark - DHMA
Clinical Trial Type:	EEA CTA
Trial Status:	Prematurely Ended
Date on which this record was first entered in the EudraCT database:	2012-06-27
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

Denmark - DHMA

A.2

EudraCT number

2012-001557-46

A.3

Full title of the trial

Perioperativ installation of ropivacain in mastectomy – with or without axillary lymph node dissection after sentinel node diagnostics or known lymph node metastasis – A double-blind, randomized clinical trial of the effect on postoperative pain

Perioperativ installation af ropivacain ved mastektomi – med eller uden aksilrømning efter sentinel node diagnostik eller kendte lymfeknudemetastaser - En dobbeltblindet randomiseret klinisk undersøgelse af den postoperative smertestillende effekt

A.3.1

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

A.4.1

Sponsor's protocol code number

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	Sydvestjysk Sygehus, Esbjerg
B.1.3.4	Country	Denmark
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	Sydvestjysk Sygehus, Esbjerg
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Sydvestjysk Sygehus, Esbjerg
B.5.2	Functional name of contact point	Afdelingen for Operation og Anæstes
B.5.3	Address:
B.5.3.1	Street Address	Finsensgade 35
B.5.3.2	Town/ city	Esbjerg
B.5.3.3	Post code	6700
B.5.3.4	Country	Denmark
B.5.4	Telephone number	+4579182645
B.5.5	Fax number	+4579182655
B.5.6	E-mail	srunel@dadlnet.dk
B.Sponsor: 2
B.1.1	Name of Sponsor	Odense Universitetshospital
B.1.3.4	Country	Denmark
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	Sydvestjysk Sygehus, Esbjerg
B.4.2	Country	Denmark
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Odense Universitetshospital
B.5.2	Functional name of contact point	Søren Rune Larsen
B.5.3	Address:
B.5.3.1	Street Address	Kløvervænget 20B, 7. sal
B.5.3.2	Town/ city	Odense C
B.5.3.3	Post code	5000
B.5.3.4	Country	Denmark
B.5.4	Telephone number	+4540603179
B.5.6	E-mail	srunel@dadlnet.dk

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	Ropivacain, Fresenius Kabi ® Solution for infusion 2 mg/ml
D.2.1.1.2	Name of the Marketing Authorisation holder	Fresenius Kabi
D.2.1.2	Country which granted the Marketing Authorisation	Denmark
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	Ropivacain
D.3.2	Product code	"Not Applicable"
D.3.4	Pharmaceutical form	Solution for infusion
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Infiltration
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	ROPIVACAINE
D.3.9.1	CAS number	84057-95-4
D.3.9.4	EV Substance Code	SUB10382MIG
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
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	amide-type local anesthetics

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 infusion
D.8.4	Route of administration of the placebo	Infiltration

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Unilateral mastectomy with or without axillary lymph node dissection

Unilateral mastektomi med og uden aksilrømning

E.1.1.1

Medical condition in easily understood language

Unilateral removal of the breast with or without removal of lymph nodes in the armpit

Ensidig fjernelse af bryst med eller uden fjernelse af lymfeknuder i armhulen

E.1.1.2

Therapeutic area

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

MedDRA Classification

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 investigate the effect on pain relief, after installation of ropivacaine with adrenaline in unilateral mastectomy with or without axillary lymph node dissection, at the end of the operation.
The effect is rated via VAS-score (Visual Analogue Scale) an modified VAS-score

At undersøge den smertelindrende effekt af ropivacain med adrenalin ved installation ved unilateral mastektomi med og uden aksilrømning givet ved operationens afslutning.
Effekten vurderes postoperativt ved hjælp af VAS-score (Visuel Analog Skala) og modificeret VAS-score.

E.2.2

Secondary objectives of the trial

Secondary to evaluate the effect on PONV (Postoperative nausea and vomiting), postoperative use of analgesia and antiemetic, length of hospital stay and time till first mobilisation.

Sekundært vurderes om installationen har effekt på PONV (Postoperative nausea and vomiting), det postoperative forbrug af smerte- og kvalmestillende medicin, på indlæggelsestiden og på tiden til mobilisering.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Unilateral mastectomy with or without axillary lymph node dissection after sentinel lymph node biopsy or known lymph node metastases
2. Woman
3. Age > 18 years
4. Capable of giving written informed consent
5. ASA 1-2 (American Society of Anaesthesiologists physical status classification system)

1. Unilateral mastektomi med eller uden aksilrømning efter sentinel node diagnostik eller kendte lymfeknudemetastaser.
2. Kvinde.
3. Alder > 18 år
4. Myndig.
5. ASA 1-2 (American Society of Anaesthesiologists klassifikationssystem af patientens almen tilstand)

E.4

Principal exclusion criteria

1. Person not capable of using VAS
2. Surgical complications demanding reoperation of the affected breast
3. Any kind of former surgery to the affected breast
4. Pregnancy
5. Patient not capable of giving written informed consent
6. Patient having other kind of breast surgery or axillary lymph node dissection
7. Patient whit new onset of pain or deterioration to chronic pain during the last 24 hours
8. Preoperative receiving treatment with medicine (prescript or non prescript) for new onset of pain or deterioration to chronic pain during the last 14 days. (Patients with well controlled chronic pain without deterioration may participate in the trial)
9. Preoperative receiving treatment with medicine for nausea or vomiting during the last 14 days
10. Patients receiving treatment with MAO-inhibiters or Tricyclic antidepressants during the last 3 months.
11. Patient known to suffer from migraine
12. Other kind of anaesthesia than the one described in the protocol
13. Contraindication towards the investigational medicinal product

1. Personer som ikke er i stand til at bruge VAS.
2. Operationskomplikationer som kræver re-operation i samme bryst.
3. Enhver form for tidliger operation i samme bryst.
4. Graviditet.
5. Pt. som ikke er i stand til at give samtykke.
6. Pt. som får foretaget anden form for brystkirurgi eller aksilrømning.
7. Pt. med nyopståede smerter eller forværring af kroniske smerter inden for det sidste døgn
8. Præoperativt i behandling med medicin (håndkøbs såvel som receptpligtig) mod nyopståede smerte eller mod forværring af kroniske smerter de sidste 14 dage. (Patienter med velbehandlede kroniske smerter uden forværring kan deltage)
9. Præoperativt i behandling med medicin mod kvalme eller opkast de sidste 14 dage.
10. Patienter i behandling med MAO-hæmmere og/eller tricycliske antidepressiva de sidste 3 måneder.
11. Pt. med kendt migræne
12. Anden bedøvelse end den i protokollen under punkt 10.1.2 beskrevne.
13. Kontraindikationer mod undersøgelsesmedicinen som beskrevet under 11.1.2.

E.5 End points

E.5.1

Primary end point(s)

Visuel analog score

E.5.1.1

Timepoint(s) of evaluation of this end point

24 houres after installation of the IMP

24 timer efter installation af undersøgelsesmedicinen

E.5.2

Secondary end point(s)

Modified visuel analog score postoperativ
Incidence of nausea
Incidence of vomiting
Use of analgetic
Use of antiemetic
Time of stay in the postanaesthesia care unit
Time till end of hospital stay
Time till first mobilisation

Modificeret visuel analog score postoperativt.
Forekomst af kvalme.
Forekomst af opkast.
Forbrug af analgetika.
Forbrug af antiemetika.
Tid på opvågningen.
Tid til udskrivning.
Tid til første mobilisering.
Tid til mobilisering.

E.5.2.1

Timepoint(s) of evaluation of this end point

24 houres after installation of the IMP

24 timer efter installation af undersøgelsesmedicinen

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

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

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

Yes

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

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

24 hours after installation of the IMP in the last patient, unless there is an adverse event that needs follow up.

24 timer efter installation af undersøgelsesmedicinen i den sidste patient, medmindre der er en hændelser eller bivirkninger som kræver yderligere opfølgning.

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

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 2012-06-27.

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)

Not different from the expected normal treatment

Ikke anderledes end den vanlige behandling

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

2012-06-27

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-06-11

P. End of Trial
P.	End of Trial Status	Prematurely Ended

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