Clinical Trials Register

Summary
EudraCT Number:	2012-004002-10
Sponsor's Protocol Code Number:	UFD-DESIC-001
National Competent Authority:	Hungary - National Institute of Pharmacy
Clinical Trial Type:	EEA CTA
Trial Status:	Completed
Date on which this record was first entered in the EudraCT database:	2012-10-08
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

2012-004002-10

A.3

Full title of the trial

Comparison of the effectiveness of desloratadine monotherapy and the combined cinnarizine and iprazochrome therapy for the treatment of urticaria factitia

A.3.1

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

Combined treatment of cinnarizine and iprazochrome in urticaria factitia

A.4.1

Sponsor's protocol code number

UFD-DESIC-001

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	Department of Dermatology and Allergology, University of Szeged
B.1.3.4	Country	Hungary
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	Department of Dermatology and Allergology, University of Szeged
B.4.2	Country	Hungary
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1	Name of organisation	Department of Dermatology and Allergology, University of Szeged
B.5.2	Functional name of contact point	Zsuzsanna Bata-Csörgő
B.5.3	Address:
B.5.3.1	Street Address	Korányi fasor 6.
B.5.3.2	Town/ city	Szeged
B.5.3.3	Post code	H-6720
B.5.3.4	Country	Hungary
B.5.4	Telephone number	+3662546402
B.5.5	Fax number	+3662546402
B.5.6	E-mail	bata@mail.derma.szote.u-szeged.hu

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	No
D.2.1.2	Country which granted the Marketing Authorisation	Hungary
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	Stugeron
D.3.9.1	CAS number	298-57-7
D.3.9.3	Other descriptive name	CINNARIZINE
D.3.9.4	EV Substance Code	SUB06302MIG
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	25
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	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	No
D.2.1.2	Country which granted the Marketing Authorisation	Hungary
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	Divascan
D.3.9.1	CAS number	7248-21-7
D.3.9.3	Other descriptive name	Iprazochrome
D.3.9.4	EV Substance Code	SUB08277MIG
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	2,5
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.IMP: 3
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	No
D.2.1.2	Country which granted the Marketing Authorisation	Hungary
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	Aerius
D.3.9.1	CAS number	100643-71-8
D.3.9.3	Other descriptive name	DESLORATADINE
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	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

E. General Information on the Trial

E.1 Medical condition or disease under investigation

E.1.1

Medical condition(s) being investigated

Among physical urticaria patients about 20-30% have urticaria factitia. The pathomechanism of urticaria factitia is not clear. Antihistamines are used to treat the condition, and this is in accordance with the most recent European Guideline. However, the efficacy of antihistamine therapy in urticaria factitia is not sufficiently proven by clinical studies.Cinnarizine and iprazochrome therapy is an effective well tolerated therapy in urticaria factitia.

E.1.1.1

Medical condition in easily understood language

Patients in the study group will receive 3x1 tablets cinnarizine and 2x1 tablets iprazochrome daily for 3 to 6 months.

E.1.1.2

Therapeutic area

Body processes [G] - Immune system processes [G12]

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

Determining the efficacy of the combined cinnarizine and iprazochrome therapy for the treatment of urticaria factitia disease.
We enroll into the study forty urticaria factitia patients between the ages of 16 and 64 years old. These patients are to be treated with the diagnosis of urticaria factitia in Szeged, at the Department of Dermatology and Allergology Clinic. We will diagnose the disease using a dermographometer. This study lasts for a period of 6 month, and we plan four visits during the study. We divide the patients into two groups based on chance (A Group, B Group).
A Group: patients will be receiving 10 mg Aerius (desloratadine) tablets twice a day (2x2 tblets/day)
B Group: patients will be receiving 25 mg Stugeron (3x1 tablets/day) (cinnarizine) tablets three times daily and 2,5 mg Divascan (iprazochrome) tablets twice a day

E.2.2

Secondary objectives of the trial

Cinnarizine and iprazochrome therapy is an effective well tolerated therapy in urticaria factitia. We plan to conduct a prospective study to compare this therapy to the conventional antihistamine therapy.

E.2.3

Trial contains a sub-study

E.3

Principal inclusion criteria

We enroll into the study forty urticaria factitia patients between the ages of 16 and 64 years old. These patients are to be treated with the diagnosis of urticaria factitia in Szeged, at the Department of Dermatology and Allergology Clinic. We will diagnose the disease using a dermographometer. Patients involved in the study will not suffer from major medical illnesses.

E.4

Principal exclusion criteria

Exclusion criteria will be pregnancy, lactation, other types of mechanical and physical urticaria and history of malignancy within 5 years of occurrence.

E.5 End points

E.5.1

Primary end point(s)

This study lasts for a period of 6 month, and we plan four visits during the study. We divide the patients into two groups based on chance (A Group, B Group).
A Group: patients will be receiving 10 mg Aerius (desloratadine) tablets twice a day
B Group: patients will be receiving 25 mg Stugeron (cinnarizine) tablets three times daily and 2,5 mg Divascan (iprazochrome) tablets twice a day
I. Visit:
Screening and enrollment of the patients
Group classification (A or B Group)
Initiation of treatment
Completing Quality of life questionnaire
Determining the severity index (Breneman index)
II.Visit: 4 weeks after starting medical treatment
Skin symptoms of urticaria factitia measurement
Therapy efficiency measurement with dermographometer
Completing Quality of life questionnaire
Determining the severity index (Breneman index)
Doctor and patient assess the effectiveness of therapy
Description of adverse effects

E.5.1.1

Timepoint(s) of evaluation of this end point

III. Visit: 12 weeks after starting medical treatment
Skin symptoms of urticaria factitia measurement
Therapy efficiency measurement with dermographometer
Completing Quality of life questionnaire
Determining the severity index (Breneman index)
Doctor and patient assess the effectiveness of therapy
Description of adverse effects

E.5.2

Secondary end point(s)

Skin symptoms of urticaria factitia measurement
Therapy efficiency measurement with dermographometer
Completing Quality of life questionnaire
Determining the severity index (Breneman index)
Doctor and patient assess the effectiveness of therapy
Description of adverse effects

E.5.2.1

Timepoint(s) of evaluation of this end point

IV. Visits: 6 month after starting medical treatment
Skin symptoms of urticaria factitia measurement
Therapy efficiency measurement with dermographometer
Completing Quality of life questionnaire
Determining the severity index (Breneman index)
Doctor and patient assess the effectiveness of therapy
Description of adverse effects

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

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

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)

Yes

E.8.2.2

Placebo

E.8.2.3

Other

E.8.2.3.1

Comparator description

antihistamine- desloratadine

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

We plan to conduct a prospective study to compare this therapy to the conventional antihistamine therapy.Patients in the study group will receive 3x1 tablets cinnarizine and 2x1 tablets iprazochrome daily for 3 to 6 months. This study lasts for a period of 6 month, and we plan four visits during the study. We divide the patients into two groups based on chance (A Group, B Group).

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

Yes

F.1.1

Number of subjects for this age range:

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)

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:

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)

This study lasts for a period of 6 month, and we plan four visits during the study.
IV. Visits:
Skin symptoms of urticaria factitia measurement
Therapy efficiency measurement with dermographometer
Completing Quality of life questionnaire
Determining the severity index (Breneman index)
Doctor and patient assess the effectiveness of therapy
Description of adverse effects

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

2012-12-10

Ethics Committee Opinion of the trial application

Favourable

Ethics Committee Opinion: Reason(s) for unfavourable opinion

Date of Ethics Committee Opinion

2012-11-20

P. End of Trial
P.	End of Trial Status	Completed

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