Clinical Trials Register

Summary
EudraCT Number:	2011-004823-11
Sponsor's Protocol Code Number:	remifentanil2011
National Competent Authority:	Italy - Italian Medicines Agency
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-08-31
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

2011-004823-11

A.3

Full title of the trial

Randomized prospective multicenter study on remifentanil analgesic efficacy in labor: intermittent intravenous infusion administration vs continuous intravenous infusion

Studio prospettico multicentrico randomizzato sulla efficacia analgesica di remifentanil nel travaglio di parto: somministrazione in infusione endovenosa intermittente vs infusione endovenosa continua

A.3.1

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

remifentanil efficacy in labor

Efficacia del remifentanil nel traviglio di parto

A.3.2

Name or abbreviated title of the trial where available

remifentanil2011

A.4.1

Sponsor's protocol code number

remifentanil2011

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	AZIENDA OSPEDALIERA UNIVERSITARIA CAREGGI
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	dipartimento universitario
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	azienda ospedaliero-universitaria careggi
B.5.2	Functional name of contact point	sod anestesia DAIMI
B.5.3	Address:
B.5.3.1	Street Address	largo Brambilla 3
B.5.3.2	Town/ city	firenze
B.5.3.3	Post code	50134
B.5.3.4	Country	Italy
B.5.4	Telephone number	055 7947021
B.5.5	Fax number	055 7947447
B.5.6	E-mail	bitossiu@aou-careggi.toscana.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	ULTIVA*IV 5FL 1MG 3ML
D.2.1.1.2	Name of the Marketing Authorisation holder	GLAXOSMITHKLINE SpA
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	Powder for injection
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Intravenous use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	REMIFENTANIL HYDROCHLORIDE
D.3.9.1	CAS number	132539-07-2
D.3.9.4	EV Substance Code	SUB04215MIG
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	1
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

women during labor

donne in travaglio di parto

E.1.1.1

Medical condition in easily understood language

women during labor

donne in travaglio di parto

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	15.0
E.1.2	Level	HLT
E.1.2	Classification code	10029772
E.1.2	Term	Normal pregnancy, labour and delivery
E.1.2	System Organ Class	10036585 - Pregnancy, puerperium and perinatal conditions

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 compare analgesic efficacy of continuous vs intermittent administration of remifentanil at the end of the first hour of labor

Confrontare l’efficacia analgesica della somministrazione continua vs intermittente di Remifentanil al termine della prima ora del travaglio di parto

E.2.2

Secondary objectives of the trial

- to compare analgesic efficacy of continuous vs intermittent administration of remifentanil during the whole labor
- to compare the incidence of maternal and neonatal side effects associated with the use of these two methods
- to compare mother’s level of satisfaction towards these two methods at the end of labor

- Confrontare l’efficacia analgesica della somministrazione continua vs intermittente di Remifentanil durante l’intera durata del travaglio di parto
- Confrontare l’incidenza di effetti collaterali materni e neonatali associati all’utilizzo delle due metodiche
- Confrontare il livello di gradimento materno espresso nei confronti delle due metodiche al termine del travaglio di parto

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

- woman in labor with contraindication for peridural analgesia; particularly: ● impaired blood coagulation parameters or impaired platelets count ● hypovolemia (unresponsive to pharmacological treatment) ● sepsis ● infection in the site of insertion of the peridural catheter ● tattoo in the site of insertion of the peridural catheter ● allergy to local anesthetics ● intracranial hypertension ● neurological disease in active phase
- lack of consent (preference for less invasive methods)
- ASA I or II
- cervical dilatation < 5 cm
- cephalic fetal presentation
- age ≥ 18 years
- written informed consent

- partoriente in travaglio di parto in cui sia controindicata l’analgesia peridurale; in particolare :
● alterazioni dei parametri emocoagulativi e della conta delle piastrine ● ipovolemia non responsiva al trattamento farmacologico ● sepsi ● infezione nel punto di inserimento del catetere peridurale ● tatuaggio nel punto di inserimento del catetere peridurale ● allergia agli anestetici locali ● ipertensione endocranica ● malattia neurologica in fase attiva
- partoriente in travaglio di parto che, rifiutando la peridurale, acconsenta all’analgesia endovenosa con Remifentanil quale metodica analgesica alternativa
- classe ASA I o II
- dilatazione cervicale < 5 cm - presentazione fetale cefalica
- età ≥ 18 anni
- consenso informato scritto

E.4

Principal exclusion criteria

- previous treatment with analgesic drugs - pre-eclampsia - insulin-dependent diabetes - toxic substance abuse - opioids allergy - pathological obesity (BMI > 40)

- precedente trattamento con farmaci analgesici - pre-eclampsia - diabete insulino-dipendente - abuso di sostanze tossiche - allergia agli oppioidi - obesità patologica (BMI>40)

E.5 End points

E.5.1

Primary end point(s)

in each woman pain will be measured through the administration of a VAS with values from 0 to 10; this evaluation will be done at the beginning of the analgesia and after 60 minutes

In ogni donna il dolore verrà misurato attraverso la somministrazione di una VAS con scala di valori compresi tra 0 e 10. La valutazione verrà effettuata a 60 minuti dall’introduzione della terapia analgesica ed i valori di VAS ottenuti confrontati con i basali presenti all’inizio dell’analgesia

E.5.1.1

Timepoint(s) of evaluation of this end point

1 hour

1 ora

E.5.2

Secondary end point(s)

- in each woman pain will be measured through the administration of a VAS with values from 0 to 10; this evaluation will be done at the beginning of the analgesia, after 5 minutes and every 30 minutes until the end of labor;
- the sedation will be measured through sedation score at the beginning of the analgesia and every 60 minutes until the end of labor;
- woman’s vital signs will be measured at the beginning of labor, every 5 minutes until the first half hour and then every 30 minutes until the end of labor by instruments routinely present in delivery rooms. Particularly heart rate will be evaluated by 3-leads ECG, blood pressure by sphygmomanometers, arterial oxygen saturation by infrared pulse oximetry and respiratory rate by direct measurement;
- mother’s episods of nausea, vomiting or pruritus will be recorded. - fetal heart rate will be measured by cardiotocography continuously during the labor; in particular decreases in heart rate above 20% in respect to time zero (if not associated with uterine contractions) will be sought; - fetal vitality and fetal primary vital functions will be evaluated through Apgar score at the first and fifth minute. A blood gas analysis on the cord blood with cooximetric method and fetal pH will be recorded at the 15th minute and after 2 hours; - In each woman the overall efficacy of these two methods in improving patients’ comfort during the labor will be evaluated through an anonimous satisfaction form with a 5-points evaluation scale.

- In ogni donna il dolore verrà misurato attraverso la somministrazione di una VAS con scala di valori compresi tra 0 e 10; la valutazione verrà effettuata all’inizio dell’analgesia, dopo 5 minuti ed ogni 30 minuti fino al termine del travaglio di parto.
- La sedazione della partoriente verrà misurata tramite sedation score all’inizio dell’analgesia ed ogni 60 minuti fino al termine del travaglio di parto.
- I parametri vitali della partoriente verranno misurate all’inizio del travaglio, ogni 5 minuti fino alla prima mezzora e quindi ogni 30 minuti fino al suo termine tramite strumentario routinariamente presente nelle sale parto. In particolare la frequenza cardiaca verrà valutata tramite elettrocardiografia a 3 derivazioni, la pressione arteriosa attraverso misurazione incruente tramite sfignomanometria, la saturazione di ossigeno arteriosa tramite pulsossimetria ad infrarossi e la frequenza respiratoria tramite misurazione diretta.
- Verranno registrati eventuali episodi di nausea, vomito e prurito materni. - La frequenza cardiaca fetale verrà misurata con cardiotocografo in continuo durante tutto il travaglio; verranno ricercate, in particolare, diminuzioni della frequenza cardiaca superiori al 20% rispetto al tempo zero non associate a contrazioni uterine. - All’espletamento del parto la vitalità e l’efficienza delle funzioni vitali primarie del neonato verranno valutate tramite la somministrazione del punteggio di Apgar al primo ed al quinto minuto. Verrà inoltre effettuata un esame emogasanalitico da sangue cordonale tramite metodica coossimetrica ed il pH fetale verrà indicato al quindicesimo minuto. - In ogni donna l’efficacia complessiva delle due metodiche nel migliorare il comfort delle pazienti durante il parto verrà valutato tramite un questionario anonimo di gradimento con una scala di misurazione a 5 punti.

E.5.2.1

Timepoint(s) of evaluation of this end point

whole length of labor

l'intera durata del travaglio di parto

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

Yes

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)

Yes

E.7.4

Therapeutic use (Phase IV)

E.8 Design of the trial

E.8.1

Controlled

Yes

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

Yes

E.8.2.3.1

Comparator description

stesso farmaco, altra metodica di somministrazione

same IMP in other method of administration

E.8.2.4

Number of treatment arms in the trial

E.8.3

The trial involves single site in the Member State concerned

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

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:

340

F.1.3

Elderly (>=65 years)

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

F.3.3.2

Women of child-bearing potential using contraception

F.3.3.3

Pregnant women

Yes

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

340

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

nessuno

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

2012-08-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-02-06

P. End of Trial
P.	End of Trial Status	Completed

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