Clinical Trials Register

Summary
EudraCT Number:	2011-002784-24
Sponsor's Protocol Code Number:	2011-11
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:	2013-07-12
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

2011-002784-24

A.3

Full title of the trial

STRONG TREAT 1 to 4 - randomized, open-label, multi centre, phase III clinical trial on multiple versus single dose of ivermectin for the treatment of strongyloidiasis

STRONG TREAT 1 to 4 - Ensayo clínico multicéntrico randomizado abierto fase III para comparar dosis única versus dosis múltiple de ivermectina en el tratamiento de la estrongiloidiasis

A.3.1

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

Study comparing different doses of the drug ivermectin for the treatment of strongyloidiasis

Estudio que compara diferentes dosis del fármaco ivermectina para el tratamiento de la estrongiloidiasis

A.3.2

Name or abbreviated title of the trial where available

STRONG TREAT 1 to 4

A.4.1

Sponsor's protocol code number

2011-11

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	Sacro Cuore - Don Calabria Hospital
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	Cohemi project
B.4.2	Country	European Union
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Sacro Cuore - Don Calabria Hospital
B.5.2	Functional name of contact point	Centre for Tropical Diseases
B.5.3	Address:
B.5.3.1	Street Address	Via Sempreboni 5
B.5.3.2	Town/ city	Negrar (Verona)
B.5.3.3	Post code	37024
B.5.3.4	Country	Italy
B.5.4	Telephone number	+390456013563
B.5.6	E-mail	dora.buonfrate@sacrocuore.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	stromectol
D.2.1.1.2	Name of the Marketing Authorisation holder	Merck Sharp & Dohme
D.2.1.2	Country which granted the Marketing Authorisation	Netherlands
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	Tablet
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	ivermectin
D.3.9.1	CAS number	70288-86-7
D.3.9.2	Current sponsor code	NA
D.3.9.3	Other descriptive name	IVERMECTIN
D.3.9.4	EV Substance Code	SUB12089MIG
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	3
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

strongyloidiasis

estrongiloidiasis

E.1.1.1

Medical condition in easily understood language

parasitic infection

Infección parasitaria

E.1.1.2

Therapeutic area

Diseases [C] - Parasitic Diseases [C03]

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 compare different dose schedules of ivermectin for the treatment of strongyloidiasis

Comparar diferentes dosis de ivermectina para el tratamiento de la estrongiloidiasis

E.2.2

Secondary objectives of the trial

Safety and tolerability of ivermectin

Seguridad y tolerabilidad de la ivermectina

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Male and female patients older than 5 years weighting > 15 kg. Current residence in non endemic areas. Diagnosis of strongyloidiasis by positive stool examination and/or stool culture AND positive serology at any titer OR positive serology at "high" titer. Informed consent.

Pacientes de ambos sexos mayores de 5 años y con peso superior a 15Kg. Residencia actual en áreas no endémicas. Diagnóstico de estrongiloidiasis mediante examen parasitológico en heces y/o cultivo Y serología positiva a cualquier título O serología positiva a título "alto". Consentimiento informado

E.4

Principal exclusion criteria

Pregnant or lactating women. CNS diseases. Disseminated strongyloidiasis. Immunosuppressed patients. Lack of informed consent. Previous treatment (last year) with ivermectin

Embarazo o lactancia. Enfermedad del Sistema Nervioso Central. Estrongiloidiasis diseminada. Pacientes inmunosuprimidos. Falta de consentimiento informado. Tratamiento previo (durante el último año) con ivermectina.

E.5 End points

E.5.1

Primary end point(s)

Clearance of strongyloidiasis at T2 (time 2: 12 months after recruitment)

Desaparición de la infección en T2 (Tiempo 2: 12 meses tras el reclutamiento)

E.5.1.1

Timepoint(s) of evaluation of this end point

12 months

12 meses

E.5.2

Secondary end point(s)

All-cause mortality during the 12 months of follow up. Patients with partial response to the treatment. Patients with adverse reactions. Patients with symptoms cleared/not cleared at T2. Patients with incread ALT at day 17. Patients with decreased WBC count at day 17. Average difference in ALT and WBC count at day 17, compared to baseline. Average difference in eosinophil count at T2, compared with baseline

Todas las causas de mortalidad durante los 12 meses de seguimiento. Pacientes con respuesta parcial al tratamiento. Pacientes con reacciones adversas. Desaparición de los síntomas en T2 (Tiempo 2). Pacientes con ALT elevada en el día 17. Pacientes con recuento de leucocitos disminuido en el día 17. Diferencia media en ALT y recuento de leucocitos en el día 17 respecto a los basales. Diferencia media de recuento de eosinófilos en T2 (Tiempo 2) comparado con el basal.

E.5.2.1

Timepoint(s) of evaluation of this end point

12 months

12 meses

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

Yes

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

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

E.8.2.3

Other

Yes

E.8.2.3.1

Comparator description

diferentes dosis de ivermectina

different dose schedule of ivermectin

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

Yes

E.8.5.1

Number of sites anticipated in the EEA

E.8.6 Trial involving sites outside the EEA

E.8.6.1

Trial being conducted both within and outside the EEA

Yes

E.8.6.2

Trial being conducted completely outside of the EEA

E.8.6.3

If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned

Peru

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

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

Yes

F.1.1

Number of subjects for this age range:

100

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)

Yes

F.1.1.5.1

Number of subjects for this age range:

F.1.1.6

Adolescents (12-17 years)

Yes

F.1.1.6.1

Number of subjects for this age range:

F.1.2

Adults (18-64 years)

Yes

F.1.2.1

Number of subjects for this age range:

200

F.1.3

Elderly (>=65 years)

Yes

F.1.3.1

Number of subjects for this age range:

100

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

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 2013-07-12.

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

200

F.4.2

For a multinational trial

F.4.2.1

In the EEA

380

F.4.2.2

In the whole clinical trial

400

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

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

2013-09-03

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2013-01-15

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

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