Clinical Trials Register

Summary
EudraCT Number:	2012-003506-27
Sponsor's Protocol Code Number:	BILA-3312/PED
National Competent Authority:	Poland - Office for Medicinal Products
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2013-01-03
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

Poland - Office for Medicinal Products

A.2

EudraCT number

2012-003506-27

A.3

Full title of the trial

A multicenter, double-blind, randomized, placebo-controlled, parallel group study to evaluate the safety and tolerability of 10 mg once daily bilastine in children from 2 to 11 years of age with either allergic rhinoconjunctivitis or chronic urticaria.

A.3.1

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

Clinical trial in children from 2 to 11 years with either allergic rhinonconjuctivitis or chronic urticaria in order to evaluate the safety and tolerability of 10 mg once daily bilastine

A.3.2

Name or abbreviated title of the trial where available

Bilastine, Safety and Tolerability study in Children (BISAFE)

A.4.1

Sponsor's protocol code number

BILA-3312/PED

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/137/2012

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	FAES FARMA, S.A.
B.1.3.4	Country	Spain
B.3.1 and B.3.2	Status of the sponsor	Commercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1	Name of organisation providing support	FAES FARMA, S.A.
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	Nuvisan
B.5.2	Functional name of contact point	Clinical Monitoring
B.5.3	Address:
B.5.3.1	Street Address	Calle Rosa de Lima 1 bis, Edificio Alba
B.5.3.2	Town/ city	Las Matas (Madrid)
B.5.3.3	Post code	28290
B.5.3.4	Country	Spain
B.5.4	Telephone number	+3491 372 60 00
B.5.5	Fax number	+3491 372 60 60
B.5.6	E-mail	Santiago.Zas@nuvisan.com

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	- Bilaxten (for Spain, Portugal, Poland and Peru) - Lendin (for Hungary) - Nixar (for Croatia) - Bilastina FAES (for Argentina)
D.2.1.1.2	Name of the Marketing Authorisation holder	Menarini International Operations Luxembourg, S.A.
D.2.1.2	Country which granted the Marketing Authorisation	Poland
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	Dispersible tablet
D.3.4.1	Specific paediatric formulation	Yes
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	Bilastine
D.3.9.1	CAS number	202189-78-4
D.3.9.2	Current sponsor code	F-96221-BM1 (polymorph I)
D.3.9.3	Other descriptive name	Bilastine
D.3.9.4	EV Substance Code	SUB37845
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	10
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
D.8 Placebo: 1
D.8.1	Is a Placebo used in this Trial?	Yes
D.8.3	Pharmaceutical form of the placebo	Dispersible tablet
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

Allergic Rhinoconjunctivitis and Chronic Urticaria

E.1.1.1

Medical condition in easily understood language

Allergic Rhinoconjunctivitis and Chronic Urticaria

E.1.1.2

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

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

The study objectives will be to evaluate the safety and tolerability of 10 mg once daily bilastine in children from 2 to 11 years of age with either allergic rhinoconjunctivitis or chronic urticaria. The primary objective will be the evaluation of the safety (TEAEs, Treatment Emergent Adverse Events).

E.2.2

Secondary objectives of the trial

The assessment of:
•safety and tolerability of bilastine in terms of physical examination, vital signs, ECG, blood tests, somnolence/sedation.
•quality of life.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

(1) Boys and girls between 2 and 11 years old, inclusive, at screening.
(2) Documented history of allergic rhinoconjunctivitis (AR) or chronic urticaria (CU) with clinical symptoms at study entry.
(3) For AR patients, a positive skin prick test/RAST for at least one allergen.
(4) A 12 lead ECG obtained at screening within acceptable limits, moreover in absence of any drug effect or disease, QTc interval values (msec) after Fridericia’s correction must be normal (not prolonged). The values considered to be normal are lower than 440 msec.
(5) Children who have written consent from their parent(s)/guardian to participate in the study. Children should be informed according to their understanding (assent form will be obtained whenever possible).

E.4

Principal exclusion criteria

(1) Non-allergic rhinitis or acute urticaria.
(2) Intake of particular medications with antiallergenic activities or sedative properties.
(3) Known allergy/hypersensitivity to the study drug (bilastine) or its inactive ingredients.
(4) Patients who are taking or have taken any of the following medications prior to randomisation in the study and have not complied with the specified washout period of 7 days unless otherwise noted:
• Oral corticosteroids.
• Antihistamines: Loratadine/ desloratadine (10 days) other systemic antihistamines (3 days).
• Anti-leukotrienes.
• Delayed-release corticosteroids (3 months).
• Ketotifen (2 weeks).
• Macrolides antibiotics and imidazolic antifungals (systemic).
• Anticholinergics.
• Investigational medication or antibodies.
• Regular schedule immunotherapy can be maintained throughout the study but will be disallowed from 24h prior to 24h after first study dosing.
(5) Clinically relevant abnormal laboratory values indicative of physical illness (including clinically significant ECG abnormalities as judged by the investigator; e.g. Wolff-Parkinson-White syndrome or long QT syndrome), or patient whose health could be harmed by their participation in the study at investigator criteria.
(6) Hypersensitivity to H1 antihistamines or benzimidazoles.
(7) Any clinical conditions or relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, haematological, endocrine or neurological diseases that in the opinion of the investigator would make the subject unsuitable for the study or interfere with the aim of the study.
(8) Children or parent(s) unable to comply with the study requirements (attendance to visits), unable to take the study treatment, or children that should have to travel to another geographic area during the course of the study.
(9) Girl who is pregnant or lactating.
(10) Children who have a recent history (within previous 12 months) of drug addiction or alcohol abuse.
(11) Participation in another clinical study within 30 days prior to the first study drug intake.

E.5 End points

E.5.1

Primary end point(s)

Proportion of children without Treatment-Emergent Adverse Events (TEAEs) throughout the course of the study.

E.5.1.1

Timepoint(s) of evaluation of this end point

3 months

E.5.2

Secondary end point(s)

• Proportion of children with related TEAEs throughout the course of the study.
• Incidence of TEAEs by System and Organ Class (SOC) and Preferred Term (PT) using MedDRA terminology.
• Laboratory blood tests (haematology and biochemistry) performed at baseline and end of treatment.
• Assessment of cardiac safety by ECG recording at each visit.
• Assessment of somnolence or sedation, by means of the Pediatric Sleep Questionnaire (PSQ) at each visit.
• Assessment of the child’s Quality of Life (QoL) by means of the Paediatric Rhinitis Quality of Life Questionnaire (PRQLQ), and the Children’s Dermatology Life Quality Index (CDLQI) to be administered to children according to the relevant disease. QoL scales will be administered at baseline and at the end of treatment.

E.5.2.1

Timepoint(s) of evaluation of this end point

3 months

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

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)

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

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

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

Argentina

Croatia

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:

504

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:

504

F.1.1.6

Adolescents (12-17 years)

F.1.2

Adults (18-64 years)

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

Yes

F.3.3.1

Women of childbearing potential not using contraception

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

Yes

F.3.3.6.1

Details of subjects incapable of giving consent

All the participants in the trial will be children from 2 to 11 years, so they can not give their consent personally and will need the consent of their parents or guardian

F.3.3.7

Others

F.4 Planned number of subjects to be included

F.4.1

In the member state

150

F.4.2

For a multinational trial

F.4.2.1

In the EEA

228

F.4.2.2

In the whole clinical trial

504

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

2013-02-19

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-12-18

P. End of Trial
P.	End of Trial Status	Completed
P.	Date of the global end of the trial	2014-07-11

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