Clinical Trials Register

Summary
EudraCT Number:	2010-023057-11
Sponsor's Protocol Code Number:	DC02/RUP/3/09
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Ongoing
Date on which this record was first entered in the EudraCT database:	2011-02-10
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

Hungary - National Institute of Pharmacy

A.2

EudraCT number

2010-023057-11

A.3

Full title of the trial

Efficacy and safety of rupatadine solution in the treatment of Chronic Spontaneous Urticaria (CSU) in paediatric patients (2-11 years old).

A.3.1

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

To learn more about a medicine called rupatadine, in treatment of urticarial itchy wheals in children (2-11 years old).

A.4.1

Sponsor's protocol code number

DC02/RUP/3/09

A.7

Trial is part of a Paediatric Investigation Plan

Yes

A.8

EMA Decision number of Paediatric Investigation Plan

P/29/2010

B. Sponsor Information
B.Sponsor: 1
B.1.1	Name of Sponsor	J. Uriach y Compañía, 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	J. Uriach y Compañía, 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	J. Uriach y Compañía, S.A.
B.5.2	Functional name of contact point	Clinical Development and Medical Ad
B.5.3	Address:
B.5.3.1	Street Address	Póligon Industrial Riera de Caldes
B.5.3.2	Town/ city	Barcelona
B.5.3.3	Post code	07184
B.5.3.4	Country	Spain
B.5.4	Telephone number	3493864 96 92na
B.5.5	Fax number	3493864 66 06na
B.5.6	E-mail	clin@uriach.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	Tamalis
D.2.1.1.2	Name of the Marketing Authorisation holder	Uriach SA
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	Rupatadine
D.3.2	Product code	UR-12592F
D.3.4	Pharmaceutical form	Oral solution
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	Rupatadine
D.3.9.1	CAS number	182349-12-8
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
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.IMP: 2
D.1.2 and D.1.3	IMP Role	Comparator
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	AERIUS
D.2.1.1.2	Name of the Marketing Authorisation holder	Schering-Plough Europe
D.2.1.2	Country which granted the Marketing Authorisation	European Union
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	Oral solution
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	DESLORATADINE
D.3.9.1	CAS number	100643-71-8
D.3.9.4	EV Substance Code	SUB01596MIG
D.3.10	Strength
D.3.10.1	Concentration unit	mg/ml milligram(s)/millilitre
D.3.10.2	Concentration type	equal
D.3.10.3	Concentration number	0.5
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	Oral solution
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

Treatment of Chronic Spontaneous Urticaria (CSU) in paediatric patients (2-11 years old).

E.1.1.1

Medical condition in easily understood language

urticarial itchy wheals

E.1.1.2

Therapeutic area

Diseases [C] - Skin and Connective Tissue Diseases [C17]

MedDRA Classification

E.1.2 Medical condition or disease under investigation

E.1.2	Version	14.0
E.1.2	Level	LLT
E.1.2	Classification code	10009159
E.1.2	Term	Chronic urticaria
E.1.2	System Organ Class	10040785 - Skin and subcutaneous tissue disorders

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 objective is to evaluate the efficacy and safety of rupatadine in the treatment of chronic spontaneous urticaria symptoms over a 6-week treatment period compared to placebo and desloratadine.
The main efficacy endpoint will be the change of the adapted Urticaria Activity Score (UAS) over the 42 day treatment period (based on diary card assessed by patient’s parents), comparing the cumulative adapted UAS of the 7 days (UAS7) prior to Visit 0 to the cumulative adapted UAS of the 7 days prior to Visit 2

E.2.2

Secondary objectives of the trial

Secondary efficacy measurements will be:
• Change from baseline over the 42-day treatment period in the mean adapted number of wheals (MNW score)
• Change from baseline over the 42-day treatment period in the mean pruritus score (MPS score)
• Quality of Life (QoL) using the validated Children’s Dermatology Life Quality Index (CDLQI) for children aged ≥ 4 years old.
• Investigator’s, parent’s and patient’s global assessment of efficacy using a Visual Analogue Scale (VAS).
• Time to discontinuation due to treatment failure.
• Progression of the adapted Urticaria Activity Score (UAS), and progression of each individual symptom score over the 42 day treatment period.
• Analysis of responder patients profile.
• Use of rescue medication.
Safety measurements will include:
• Adverse Events incidence
• Related Adverse Events incidence
• Serious Adverse Events incidence
• Clinically relevant changes
The study drug formulation will be assessed with a specific questionnaire.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

Children can participate in the study if they meet all the following inclusion criteria:
(1) Boys and girls between 2 and 11 years old, inclusive, at screening.
(2) Weight >10 Kg.
(3) Documented history of chronic spontaneous urticaria (urticarial itchy wheals) with or without angioedema of at least 6 weeks before the selection visit.
(4) Patients with a cumulative score ≥ 12 points in the adapted Urticaria Activity Score of the 7 days (adapted UAS7) before Visit 0.
UAS is defined as the sum of the scores (0-3) of the two symptoms assessed (pruritus and adapted number of wheals) in a daily basis. If the patients had a daily adapted UAS score of 6 (maximum severity) and they took second generation antihistamines as rescue medication, the following day cannot be counted for the adapted UAS7, due to carry-over effects of the antihistamine; and so seven valid individual days will be calculated counting backwards, beginning with the last day of the evaluation period.
(5) 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 < 450 msec.
(6) Children who have written consent from their parent/guardian to participate in the study.

E.4

Principal exclusion criteria

Children cannot enter in the study if they meet any of the following exclusion criteria:
(1) Patients with dermatological conditions such as hereditary angio-oedema or isolated dermographism, physical urticaria, urticaria caused by the ingestion of any drug or food, urticaria caused by any infection, contact urticaria, urticaria caused by vasculitis and/or collagenosis.
(2) Patient with any parasitic infestations enable to cause any urticaria like symptoms-signs (i.e. anisakiasis, strongyloidiasis, etc.).
(3) Patient under any systemic or topical medication for CU and/or an inferior wash-out period as stated (please check the protocol)
(4) Patient taking medication that is known to interact significantly with CYP3A4 isozyme of cytochrome P450 such as amiodarone, carbamazapine, cyclosporin, terfenadine, glucocorticoids, phenytoin, rifampicin, erythromycin, ketoconazole, antiretrovirals tricyclic antidepressants as well as grapefruit juice.
(5) Patient with clinically relevant abnormal laboratory values indicative of physical illness, or patient whose health could be harmed by their participation in the study at investigator criteria.
(6) Patient with ascertained of presumptive hypersensitivity to the active principle and/or formulation ingredients of the tested compounds such as children with lactose intolerance.
(7) History of anaphylaxis to drugs or allergic reactions in general, which the Investigator considers may impact on the outcome of the study.
(8) Relevant history of renal, hepatic, gastrointestinal, cardiovascular, respiratory, haematological, endocrine or neurological diseases that may interfere with the aim of the study.
(9) Patient that after review of their medical history is considered by the investigator as unresponsive to antihistaminic treatment.
(10) Children or parents unable to comply with the study requirements (attendance to visits), unable to complete the patient diary and take the study treatment, or children that should have to travel to another geographic area during the course of the study.
(11) Girl who is pregnant or lactating.
(12) Children who have a recent history (within previous 12 months) of drug addiction or alcohol abuse.
(13) Children taking drugs strongly associated with torsade de pointes such as disopyramide, procainamide, quinidine, amiodarone, sotalol, thioridazine, beperidil or prenylamine.
(14) Participation in the evaluation of any drug within 3 months prior to the start of the study.

E.5 End points

E.5.1

Primary end point(s)

The main efficacy endpoint will be the change of the adapted Urticaria Activity Score (UAS) over the 42 day treatment period (based on diary card assessed by patient’s parents), comparing the cumulative adapted UAS of the 7 days (UAS7) prior to Visit 0 to the cumulative adapted UAS of the 7 days prior to Visit 2.

E.5.1.1

Timepoint(s) of evaluation of this end point

42 days

E.5.2

Secondary end point(s)

• Change from baseline over the 42-day treatment period in the mean adapted number of wheals (MNW score)
• Change from baseline over the 42-day treatment period in the mean pruritus score (MPS score)
• Quality of Life (QoL) using the validated Children’s Dermatology Life Quality Index (CDLQI) for children aged ≥ 4 years old.
• Investigator’s, parent’s and patient’s global assessment of efficacy using a Visual Analogue Scale (VAS).
• Time to discontinuation due to treatment failure.
• Progression of the adapted Urticaria Activity Score (UAS), and progression of each individual symptom score over the 42 day treatment period.
• Analysis of responder patients profile.
• Use of rescue medication.
Safety measurements will include:
• Adverse Events incidence
• Related Adverse Events incidence
• Serious Adverse Events incidence
• Clinically relevant changes
The study drug formulation will be assessed with a specific questionnaire.

E.5.2.1

Timepoint(s) of evaluation of this end point

42 and 84 days

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)

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)

Yes

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

South Africa

E.8.7

Trial has a data monitoring committee

Yes

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

From an efficacy perspective, children will be considered as having completed the study protocol if they finish the 42 days of treatment study and had Visit 2 complete.
Children must be withdrawn for the reasons explained in the protocol.

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:

192

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:

192

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

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

Yes

F.3.3.7.1

Details of other specific vulnerable populations

Children

F.4 Planned number of subjects to be included

F.4.1

In the member state

F.4.2

For a multinational trial

F.4.2.1

In the EEA

120

F.4.2.2

In the whole clinical trial

192

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)

normal treatment of that condition

G. Investigator Networks to be involved in the Trial
G.4 Investigator Network to be involved in the Trial: 1
G.4.1	Name of Organisation	not applicable

N. Review by the Competent Authority or Ethics Committee in the country concerned

Competent Authority Decision

Authorised

Date of Competent Authority Decision

2011-02-09

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2011-01-12

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

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