Acquired Cold Urticaria MedDRA version: 9.1 Level: LLT Classification code 10009869 Term: Cold urticaria
Conditions
Interventions
Trade Name: Rupafin
Product Name: Rupafin
Pharmaceutical Form: Tablet
INN or Proposed INN: Rupatadine
Concentration unit: mg milligram(s)
Concentration type: equal
Concentration number: 10-
Pharmaceut
Sponsors
Uriach Pharma
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Male or female equal to or older than 18 years and younger than 65 years 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 Are the trial subjects under 18? no 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) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
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. Presence of lactose and galactose intolerance or with glucose-galactose malabsorption 7. Simultaneous physical urticaria that could interfere ACU clinical assessment, i.e.severe cholinergic urticaria or dermographism. 8. Simultaneous chronic urticaria that could interfere with ACU clinical assessment. 9. Vasculitis, urticaria vasculitis or cryoglobulinemia. 10. Intake of antihistamines or leukotriene antagonists within 7 days prior to the beginning of the study. 11. Intake of oral corticosteroids within 14 days prior to the beginning of the study. 12. Use of depot corticosteroids or chronic systemic corticosteroids within 21 days before beginning of the study 13. Use of ketoconazole, erythromycine or potential inhibitors of the isoenzyme CYP3A4 of the cytochrome P450 14. 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 15. Unwilling or unable to comply with the protocol or to cooperate fully with the principal investigator and site personnel 16. Has taken any other investigational drug during the 4 weeks prior to screening visit 17. 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 18. Unable to understand the verbal and/or written informed consent. 19. History of hypersensitivity or allergic reaction to rupatadine or any other antihistamine compounds. 20. Pregnancy or breast-feeding. 21. Patients who are kept in detention by court decision or regulatory action have to be added 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: 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;Secondary Objective: 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.;Primary end point(s): critical stimulation time thresholds | — |
Countries
Germany, Spain
Outcome results
None listed