Clinical Trials Register

Summary
EudraCT Number:	2016-005207-30
Sponsor's Protocol Code Number:	0000
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:	2017-03-10
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

2016-005207-30

A.3

Full title of the trial

CLINICAL TRIAL FOR THE ADMINISTRATION OF PREOPERATIVE VITAMIN D AS PREVENTION IN TRANSITORY HYPOCALCEMIA IN POSTOPERATORY OF TOTAL THYROIDECTOMY

ENSAYO CLÍNICO PARA LA ADMINISTRACIÓN DE VITAMINA D PREOPERATORIA COMO PREVENCIÓN EN LA HIPOCALCEMIA TRANSITORIA EN EL POSTOPERATORIO DE TIROIDECTOMÍA TOTAL

A.3.1

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

CLINICAL TRIAL FOR THE ADMINISTRATION OF VITAMIN D AS PREVENTION IN TRANSITORY HYPOCALCEMIA IN POSTOPERATORY OF TOTAL THYROIDECTOMY

ENSAYO CLÍNICO PARA LA ADMINISTRACIÓN DE VITAMINA D COMO PREVENCIÓN EN LA HIPOCALCEMIA TRANSITORIA EN EL POSTOPERATORIO DE TIROIDECTOMÍA TOTAL

A.3.2

Name or abbreviated title of the trial where available

AVD

A.4.1

Sponsor's protocol code number

0000

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 SON ESPASES
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	No
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 Son Espases
B.5.2	Functional name of contact point	Marina Jiménez
B.5.3	Address:
B.5.3.1	Street Address	Calle Llotgeta 7, 2-C
B.5.3.2	Town/ city	Palma de Mallorca
B.5.3.3	Post code	07002
B.5.3.4	Country	Spain
B.5.4	Telephone number	+34672307721
B.5.5	Fax number	+34871909720
B.5.6	E-mail	m_js@hotmail.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	HIDROFEROL
D.2.1.1.2	Name of the Marketing Authorisation holder	FAES FARMA 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	VITAMIN D
D.3.2	Product code	55.315
D.3.4	Pharmaceutical form	Capsule
D.3.4.1	Specific paediatric formulation	No
D.3.7	Routes of administration for this IMP	Oral use
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	S/C27H44O/c1-19(2)8-6-9-21(4)25-15-16-26-22(10-7-17-27(25,26)5)12-13-23-18-24(28)14-11-20(23)3/h10,12-13,19,21,24-26,28H,6-9,11,14-18H2,1-5H3 Yes
D.3.9.1	CAS number	17592-07-3
D.3.9.2	Current sponsor code	00000
D.3.9.3	Other descriptive name	VITAMIN D
D.3.9.4	EV Substance Code	SUB129580
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	1596
D.3.8 to D.3.10 IMP Identification Details (Active Substances)
D.3.8	INN - Proposed INN	CALCIFEDIOL
D.3.9.1	CAS number	19356-17-3
D.3.9.2	Current sponsor code	00000
D.3.9.4	EV Substance Code	SUB06045MIG
D.3.10	Strength
D.3.10.1	Concentration unit	µg microgram(s)
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	266
D.3.11 The IMP contains an:
D.3.11.1	Active substance of chemical origin	No
D.3.11.2	Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP)	Yes
	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	Capsule
D.8.4	Route of administration of the placebo	Oral use

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Transient hypocalcaemia porstoperatoria

Hipocalcemia transitoria postoperatoria

E.1.1.1

Medical condition in easily understood language

Hypocalcemia after thyroid surgery

Hipocalcemia tras intervención de tiroides

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	20.0
E.1.2	Level	LLT
E.1.2	Classification code	10047628
E.1.2	Term	Vitamin deficiency
E.1.2	System Organ Class	100000019580

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 analyze the effectiveness of peroperative vitamin D therapy in patients who will undergo total thyroidectomy for benign multinodular goiter to evaluate the reduction of postoperative transient hypocalcaemia

Analizar la efectividad del tratamiento con vitamina D peroperatoria en pacientes que vayan a ser intervenidos de tiroidectomía total por bocio multinodular benigno para evaluar la disminución de la hipocalcemia transitoria postoperatoria

E.2.2

Secondary objectives of the trial

Not applicable

No aplicable

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

1. Patient older than 18 years
2. Diagnosis of Multinodular Goiter
3. Be able to provide informed consent prior to randomization and agree to abide by all procedures included in the protocol.

1. Paciente mayor de 18 años
2. Diagnóstico de Bocio Multinodular
3. Ser capaz de proporcionar un consentimiento informado antes de la aleatorización y estar de acuerdo en cumplir todos los procedimientos incluidos en el protocolo.

E.4

Principal exclusion criteria

1. Previous history of hypersensitivity or allergy to any of the components of the medication used in the study.
2. Existing hypercalcemia
3. Severe hypercalciuria
4. Previous history of nephrolithiasis
5. Evidence of toxicity to vitamin D

1. Historia previa de hipersensibilidad o alergia a cualquiera de los componentes de la medicación usada en el estudio.
2. Hipercalcemia existente
3. Hipercalciuria severa
4. Historia previa de nefrolitiasis
5. Evidencia de toxicidad a la vitamina D

E.5 End points

E.5.1

Primary end point(s)

Prevention of postoperative hypocalcemia in patients undergoing multinodular goiter

prevención de la hipocalcemia postoperatoria en pacientes intervenidos de bocio multinodular

E.5.1.1

Timepoint(s) of evaluation of this end point

24 h postoperative

24 h postoperatorias

E.5.2

Secondary end point(s)

Asymptomatic hypocalcemia
Symptomatic hypocalcaemia
Analytical values: Albumin and total proteins.
Preoperative and postoperative PTH

Hipocalcemia asintomática
Hipocalcemia sintomática
Valores analíticos: Albúmina y proteínas totales.
PTH preoperatoria y postoperatoria

E.5.2.1

Timepoint(s) of evaluation of this end point

24 h postoperative

24 h postoperatorias

E.6 and E.7 Scope of the trial

E.6

Scope of the trial

E.6.1

Diagnosis

E.6.2

Prophylaxis

Yes

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

Yes

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

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

To analyze the effectiveness of peroperative vitamin D treatment in patients who will undergo total thyroidectomy for benign multinodular goiter to evaluate the reduction of postoperative transient hypocalcaemia

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)

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

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

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)

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

2017-07-21

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2017-07-12

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

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