Clinical Trials Register

Summary
EudraCT Number:	2013-001921-19
Sponsor's Protocol Code Number:	BUSCAPART
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:	2014-01-16
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

2013-001921-19

A.3

Full title of the trial

Randomised, masked, placebo-controlled study to evaluate the effects of a single intravenous dose of hyoscine bromide on the duration and pain in the latent and active labor

Ensayo clínico aleatorizado, enmascarado, controlado con placebo para evaluar los efectos de una dosis única intravenosa de bromuro de hioscina sobre la duración y el dolor en la fase latente y activa del parto

A.3.1

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

use of hyoscine bromide in labor

Utilización del bromuro de hioscina durante el parto

A.4.1

Sponsor's protocol code number

BUSCAPART

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	Fundació Clínic per a la Recerca Biomèdica
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	FCRB - M. Palacio
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	Clinical Trials Unit- Hospital Clinic of Barcelona
B.5.2	Functional name of contact point	CTU CLINIC
B.5.3	Address:
B.5.3.1	Street Address	Villarroel 170
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	08036
B.5.3.4	Country	Spain
B.5.4	Telephone number	00349322754003343
B.5.5	Fax number	0034932279877
B.5.6	E-mail	svarea@clinic.ub.es

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	Buscapina
D.2.1.1.2	Name of the Marketing Authorisation holder	Boehringer Ingelheim España, 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.3.1	Product name	Buscapina
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 use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	Buscapina
D.3.9.1	CAS number	149-64-4
D.3.9.3	Other descriptive name	HYOSCINE BUTYLBROMIDE
D.3.9.4	EV Substance Code	SUB14154MIG
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	20
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

labor

parto

E.1.1.1

Medical condition in easily understood language

labor

parto

E.1.1.2

Therapeutic area

Body processes [G] - Reproductive physiologi cal processes [G08]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	16.1
E.1.2	Level	PT
E.1.2	Classification code	10029767
E.1.2	Term	Normal labour
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

Demosntrate if hyoscine bromide reduces the duration of the first active phase of labor.

Demostrar si el bromuro de hioscina disminuye el tiempo de duración de la primera fase activa del parto.

E.2.2

Secondary objectives of the trial

Demonstrate if pain or analgesic requirement decrease with hyoscine bromide use in those patients without epidural analgesia.
Demonstrate whether the effect of hyoscine bromide differs between primiparous or multiparous.

-Demostrar si el dolor o el requerimiento de analgesia disminuyen con el uso del bromuro de hioscina en aquellas pacientes sin analgesia peridural.
-Demostrar si el efecto del bromuro de hioscina difiere entre primípara o multípara.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

18 years or more
Only at term pregnancy
cephalic
No oxytocin augmentation present at the time of inclusion.
Dynamic uterine established.
Absence of risk factors high or very high by Generalitat de Catalunya

o 18 años o más
o Gestación única a término
o Presentación cefálica
o No presentar estimulación oxitócica en el momento de la inclusión.
o Dinámica uterina establecida.
o Ausencia de factores de riesgo alto o muy alto según Generalitat de Catalunya (ver anexo 2).

E.4

Principal exclusion criteria

Induction of labor
Risk factors (preeclampsia, severe maternal disease, fetal pathology)
Patients with hypersensitivity to active substance or to any of the excipients or any contraindication reflected in the Summary of buscapine characteristics

o Inducción del parto
o Factores de riesgo (preclampsia, patología materna grave, patología fetal)
o Pacientes con hipersensibilidad al principio activo o a alguno de los excipientes o con cualquier contraindicación formal reflejada en ficha técnica

E.5 End points

E.5.1

Primary end point(s)

Time to complete dilatation (continuous)

- Tiempo hasta dilatación completa (continua)

E.5.1.1

Timepoint(s) of evaluation of this end point

labour

parto

E.5.2

Secondary end point(s)

VAS at 2, 4, 6h, if epidural anesthesia
Epidural anesthesia
Time to epidural anesthesia
The need for oxytocin augmentation
Type of labor
Time of delivery
Neonatal weight
Apgar 5 and 10 minutes
PH arterial and venous umbilical cord
Admission in intensive care unit

- EVA a las 2, 4, 6h, si no anestesia peridural (continua)
- Anestesia peridural (categórica)
- Tiempo hasta anestesia peridural (continua)
- Necesidad de estimulación con oxitocina (categórica)
- Tipo de parto (categórica)
- Hora del parto (continua)
- Peso neonatal (continua)
- Apgar 5 y 10 minutos (continua)
- pH arterial y venoso cordón umbilical (continua)
- Ingreso neonato en UCI (categórica)

E.5.2.1

Timepoint(s) of evaluation of this end point

labor

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

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.8.5

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

LPLV

ultima visita de última paciente

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

E.8.9.2

In all countries concerned by the trial years

E.8.9.2

In all countries concerned by the trial months

E.8.9.2

In all countries concerned by the trial 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:

180

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

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

180

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

2014-02-11

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-12-02

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

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