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Summary
EudraCT Number:2007-005786-35
Sponsor's Protocol Code Number:DC02RUP/IV/02
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:2008-02-13
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
A. Protocol Information
A.1Member State ConcernedSpain - AEMPS
A.2EudraCT number2007-005786-35
A.3Full title of the trial
Estudio de prueba de concepto, cruzado, doble ciego, controlado con placebo para valorar si la Rupatadina 20 mg puede mejorar el umbral del tiempo critico de estimulación en pacientes con urticaria a frigore adquirida
A.3.2Name or abbreviated title of the trial where available
ACURE
A.4.1Sponsor's protocol code numberDC02RUP/IV/02
A.7Trial is part of a Paediatric Investigation Plan Information not present in EudraCT
A.8EMA Decision number of Paediatric Investigation Plan
B. Sponsor Information
B.Sponsor: 1
B.1.1Name of SponsorUriach Pharma
B.1.3.4CountrySpain
B.3.1 and B.3.2Status of the sponsorCommercial
B.4 Source(s) of Monetary or Material Support for the clinical trial:
B.4.1Name of organisation providing support
B.4.2Country
B.5 Contact point designated by the sponsor for further information on the trial
B.5.1Name of organisation
B.5.2Functional name of contact point
D. IMP Identification
D.IMP: 1
D.1.2 and D.1.3IMP RoleTest
D.2 Status of the IMP to be used in the clinical trial
D.2.1IMP to be used in the trial has a marketing authorisation Yes
D.2.1.1.1Trade name Rupafin
D.2.1.1.2Name of the Marketing Authorisation holderJ. Uriach & Company S.A.
D.2.1.2Country which granted the Marketing AuthorisationSpain
D.2.5The IMP has been designated in this indication as an orphan drug in the Community No
D.2.5.1Orphan drug designation number
D.3 Description of the IMP
D.3.1Product nameRupafin
D.3.4Pharmaceutical form Tablet
D.3.4.1Specific paediatric formulation Information not present in EudraCT
D.3.7Routes of administration for this IMPOral use
D.3.11 The IMP contains an:
D.3.11.1Active substance of chemical origin Yes
D.3.11.2Active substance of biological/ biotechnological origin (other than Advanced Therapy IMP (ATIMP) No
The IMP is a:
D.3.11.3Advanced Therapy IMP (ATIMP) Information not present in EudraCT
D.3.11.3.1Somatic cell therapy medicinal product No
D.3.11.3.2Gene therapy medical product No
D.3.11.3.3Tissue Engineered Product Information not present in EudraCT
D.3.11.3.4Combination ATIMP (i.e. one involving a medical device) Information not present in EudraCT
D.3.11.3.5Committee on Advanced therapies (CAT) has issued a classification for this product Information not present in EudraCT
D.3.11.4Combination product that includes a device, but does not involve an Advanced Therapy Information not present in EudraCT
D.3.11.5Radiopharmaceutical medicinal product No
D.3.11.6Immunological medicinal product (such as vaccine, allergen, immune serum) No
D.3.11.7Plasma derived medicinal product No
D.3.11.8Extractive medicinal product No
D.3.11.9Recombinant medicinal product Information not present in EudraCT
D.3.11.10Medicinal product containing genetically modified organisms No
D.3.11.11Herbal medicinal product No
D.3.11.12Homeopathic medicinal product No
D.3.11.13Another type of medicinal product No
D.8 Information on Placebo
D.8 Placebo: 1
D.8.1Is a Placebo used in this Trial?Yes
D.8.3Pharmaceutical form of the placeboTablet
D.8.4Route of administration of the placeboOromucosal use
E. General Information on the Trial
E.1 Medical condition or disease under investigation
E.1.1Medical condition(s) being investigated
Acquired Cold Urticaria
MedDRA Classification
E.1.2 Medical condition or disease under investigation
E.1.2Version 9.1
E.1.2Level LLT
E.1.2Classification code 10009869
E.1.2Term Cold urticaria
E.1.3Condition being studied is a rare disease No
E.2 Objective of the trial
E.2.1Main objective of the trial
To assess the effects of Rupatadine 20 mg improving (longest time) the critical stimulation time threshold (CSTTs) in ACU patients. CSTTs will be assessed with the traditional ice cube provocation method using provocation times of defined duration
E.2.2Secondary objectives of the trial
To assess the effects of Rupatadine 20 mg improving the critical temperature thresholds (CTT) in ACU patients. CTTs will be measured with the novel TEMPTest  method using different temperatures ranging from 4°C to 26°C.
E.2.3Trial contains a sub-study No
E.3Principal inclusion criteria
1. Male or female aged  18 years old

2. Previous history of acquired cold urticaria (ACU) for more than 6 weeks.

3. Diagnosis of ACU confirmed by a positive ice-cube test (described below)

4. Female subjects must have a negative serum pregnancy test result prior to enrollment into the study. Female subjects of childbearing potential (including peri-menopausal women who have had a menstrual period within one year) must be using appropriate birth control (defined as a method which results in a low failure rate, i.e. less than 1% per year, when used consistently and correctly, such as implants, injectables, some intrauterine contraceptive devices [IUDs], sexual abstinence, or a vasectomised partner) during the entire duration of the study.

5. Capable of understanding and complying with the protocol and must have signed the informed consent document prior to performance of any study-related procedures
E.4Principal exclusion criteria
1. The presence of permanent severe diseases (cardiac, renal or respiratory failure), especially those affecting the immune system, except ACU.

2. The presence of a permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract).

3. Any ongoing process of hepatic disease (liver enzymes twice the upper reference value).

4. Presence of active cancer which requires chemotherapy or radiation therapy.

5. Presence of acute urticaria.

6. Simultaneous physical urticaria that could interfere ACU clinical assessment, i.e.severe cholinergic urticaria or dermographism.

7. Simultaneous chronic urticaria that could interfere with ACU clinical assessment.

8. Vasculitis, urticaria vasculitis or cryoglobulinemia.

9. Intake of antihistamines or leukotriene antagonists within 7 days prior to the beginning of the study.

10. Intake of oral corticosteroids within 14 days prior to the beginning of the study.

11. Use of depot corticosteroids or chronic systemic corticosteroids within 21 days before beginning of the study

12. Currently abusing drugs or alcohol (> 30 gr/day; or > 1/2 drinks/day for females/males, defined according to USDA Dietary Guidelines 2000) or with a history of drug or alcohol abuse within the past two years

13. Unwilling or unable to comply with the protocol or to cooperate fully with the principal investigator and site personnel

14. Has taken any other investigational drug during the 4 weeks prior to screening visit

15. Has any condition(s) that in the investigator’s opinion would: a) warrant exclusion from the study or b) prevent the subject from completing the study

16. Unable to understand the verbal and/or written informed consent.

17. History of hypersensitivity or allergic reaction to rupatadine or any other antihistamine compounds.

18. Pregnancy or breast-feeding.

Furthermore, will be excluded during the study all the subjects that shows any waiver to the inclusion or exclusion criteria, under the criteria of principal investigator and/or medical monitor.
E.5 End points
E.5.1Primary end point(s)
critical stimulation time thresholds
E.6 and E.7 Scope of the trial
E.6Scope of the trial
E.6.1Diagnosis No
E.6.2Prophylaxis No
E.6.3Therapy No
E.6.4Safety No
E.6.5Efficacy Yes
E.6.6Pharmacokinetic No
E.6.7Pharmacodynamic No
E.6.8Bioequivalence No
E.6.9Dose response No
E.6.10Pharmacogenetic Information not present in EudraCT
E.6.11Pharmacogenomic No
E.6.12Pharmacoeconomic No
E.6.13Others Information not present in EudraCT
E.7Trial type and phase
E.7.1Human pharmacology (Phase I) No
E.7.1.1First administration to humans Information not present in EudraCT
E.7.1.2Bioequivalence study Information not present in EudraCT
E.7.1.3Other Information not present in EudraCT
E.7.1.3.1Other trial type description
E.7.2Therapeutic exploratory (Phase II) No
E.7.3Therapeutic confirmatory (Phase III) No
E.7.4Therapeutic use (Phase IV) Yes
E.8 Design of the trial
E.8.1Controlled Yes
E.8.1.1Randomised Yes
E.8.1.2Open No
E.8.1.3Single blind No
E.8.1.4Double blind Yes
E.8.1.5Parallel group No
E.8.1.6Cross over Yes
E.8.1.7Other Information not present in EudraCT
E.8.2 Comparator of controlled trial
E.8.2.1Other medicinal product(s) Yes
E.8.2.2Placebo Yes
E.8.2.3Other Information not present in EudraCT
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 No
E.8.5The trial involves multiple Member States Yes
E.8.5.1Number of sites anticipated in the EEA2
E.8.6 Trial involving sites outside the EEA
E.8.6.1Trial being conducted both within and outside the EEA No
E.8.6.2Trial being conducted completely outside of the EEA Information not present in EudraCT
E.8.7Trial has a data monitoring committee No
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
E.8.9 Initial estimate of the duration of the trial
E.8.9.1In the Member State concerned years1
E.8.9.1In the Member State concerned months0
E.8.9.1In the Member State concerned days0
E.8.9.2In all countries concerned by the trial years1
E.8.9.2In all countries concerned by the trial months0
E.8.9.2In all countries concerned by the trial days0
F. Population of Trial Subjects
F.1 Age Range
F.1.1Trial has subjects under 18 No
F.1.1.1In Utero Information not present in EudraCT
F.1.1.2Preterm newborn infants (up to gestational age < 37 weeks) Information not present in EudraCT
F.1.1.3Newborns (0-27 days) Information not present in EudraCT
F.1.1.4Infants and toddlers (28 days-23 months) Information not present in EudraCT
F.1.1.5Children (2-11years) Information not present in EudraCT
F.1.1.6Adolescents (12-17 years) Information not present in EudraCT
F.1.2Adults (18-64 years) Yes
F.1.3Elderly (>=65 years) Yes
F.2 Gender
F.2.1Female Yes
F.2.2Male Yes
F.3 Group of trial subjects
F.3.1Healthy volunteers No
F.3.2Patients Yes
F.3.3Specific vulnerable populations No
F.3.3.1Women of childbearing potential not using contraception Information not present in EudraCT
F.3.3.2Women of child-bearing potential using contraception Information not present in EudraCT
F.3.3.3Pregnant women Information not present in EudraCT
F.3.3.4Nursing women Information not present in EudraCT
F.3.3.5Emergency situation Information not present in EudraCT
F.3.3.6Subjects incapable of giving consent personally Information not present in EudraCT
F.3.3.7Others Information not present in EudraCT
F.4 Planned number of subjects to be included
F.4.1In the member state10
F.4.2 For a multinational trial
F.4.2.1In the EEA 10
F.4.2.2In the whole clinical trial 20
G. Investigator Networks to be involved in the Trial
N. Review by the Competent Authority or Ethics Committee in the country concerned
N.Competent Authority Decision Authorised
N.Date of Competent Authority Decision2008-02-08
N.Ethics Committee Opinion of the trial applicationFavourable
N.Ethics Committee Opinion: Reason(s) for unfavourable opinion
N.Date of Ethics Committee Opinion2007-12-20
P. End of Trial
P.End of Trial StatusOngoing

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