E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10009869 |
E.1.2 | Term | Cold urticaria |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main 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 |
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E.2.2 | Secondary 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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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
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E.4 | Principal 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.
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E.5 End points |
E.5.1 | Primary end point(s) |
critical stimulation time thresholds |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | Information not present in EudraCT |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | Information not present in EudraCT |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | Information not present in EudraCT |
E.7.1.2 | Bioequivalence study | Information not present in EudraCT |
E.7.1.3 | Other | Information not present in EudraCT |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | Yes |
E.8.1.7 | Other | Information not present in EudraCT |
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 | 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.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 2 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial 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
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 1 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 1 |
E.8.9.2 | In all countries concerned by the trial months | 0 |
E.8.9.2 | In all countries concerned by the trial days | 0 |