Chronic Spontaneous Urticaria
Conditions
Interventions
Trade Name: Urtimed 10mg Tabletten
Pharmaceutical Form: Tablet
INN or Proposed INN: rupatadine
CAS Number: 182349-12-8
Concentration unit: mg milligram(s)
Concentration type: up to
Concentration numbe
Sponsors
Charité Universitätsmedizin Berlin
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: • Male or female aged 18 years and older • Documented history of active CSU (urticaria and wheals) with or without an associated angioedema for at least three days per week over the last 6 weeks prior to visit 1 (screening). Urticaria symptoms must comprise wheals and itch • UAS7 of =6 during the screening phase • Overall duration of chronic spontaneous urticaria for at least 3 months • Informed consent signed and dated Able to read, understand and willing to sign the informed consent form and abide with study procedures • Willing, committed and able to return for all clinic visits and complete all study-related procedures • In females of childbearing potential: negative pregnancy test; females willing to use highly effective contraception (Pearl-Index 2 years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy) • No participation in other clinical trials 4 weeks before and after participation in this study 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 172 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
Exclusion criteria: Chronic spontaneous urticaria patients with a known resistance to nsAH in 4 times the licensed doses • Chronic spontaneous urticaria patients with a known resistance to rupatadine • Isolated presence or domination of inducible forms of urticaria or cholinergic urticaria (no chronic spontaneous urticaria) • History of adverse reactions to rupatadine or known hypersensitivity to rupatadine or its ingredients • Intake of oral corticosteroids or intravenously applied corticosteroids within 28 days prior to screening visit • Use of depot corticosteroids within 3 months prior to screening visit (inhaled corticosteroids are allowed) • Use of systemic immunosupressants/immunomodulators such as ciclosporin, dapsone, metotrexate, and comparable drugs within 28 days prior to screening visit. • Significant medical condition, in the opinion of the Investigator, rendering the patient immunocompromised or not suitable for a clinical trial • Significant concomitant illness, in the opinion of the Investigator, that would adversely affect the subject’s participation or evaluation in this study • Subjects for whom there is concern, in the opinion of the Investigator, about compliance with the protocol procedures • The presence of a permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract) Presence of active cancer which requires chemotherapy or radiation therapy • History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia • History or presence of myocardial infarction or acute myocardial ischemia • History or presence of cardiac arrhythmia which requires drug therapy • History or presence of clinically significant bradycardia (450ms in females, >430ms in males) • Blood pressure >180/100 mmHg and/or heart rate >100/min • Presence of uncorrected hypokalemia or hyperkalemia • Evidence of significant hepatic or renal disease (GOT and/or GPT >2 times above the upper reference value, serum creatinine 1.5 times above the upper reference value) • Presence of galactose intolerance, Lapp lactase deficiency or glucosegalactose malabsorption • Medication with HMG-CoA reductase inhibitors (statins) • Presence of alcohol abuse or drug addiction • Pregnancy or breast-feeding • Subjects who are inmates of psychiatric wards, prisons, or other state institutions. Existing or planned placement in an institution after ruling according to § 40 passage 1, number 4 AMG (Arzneimittelgesetz).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare CSU disease activity at the end of the follow up phase between patients that had been treated daily continuously vs. on-demand in the treatment phase.;Secondary Objective: •To compare CSU disease activity during the follow up phase between patients with response vs. non-response at the end of the treatment phase. •To compare CSU disease activity during the follow up phase between patients that had been treated daily continuously vs. on-demand in the treatment phase. •To compare the efficacy of rupatadine 10 mg during the treatment phase between patients treated daily continuously vs. on-demand. •To assess the efficacy of rupatadine 20 mg in CSU patients who not show complete symptom control with the 10 mg dose. •Evaluation of the safety profile of the rupatadine 20 mg dose. ;Primary end point(s): Comparison of the UAS7 values (change from baseline) at the end of the follow-up phase between patients that had been treated daily continuously vs. on-demand in the treatment phase.;Timepoint(s) of evaluation of this end point: Comparison of the UAS7 values (change from baseline) at the end of the follow-up phase (week 15 and 16) between patients that had been treated daily continuously vs. on-demand in the treatment phase. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Comparison of the UAS7 values (change from baseline) during the follow-up phase between patients with response vs. non-response at the end of the treatment phase. • Comparison of the UAS7 values (change from baseline) during the follow-up phase (period from week 10 to week 14) between patients that had been treated daily continuously vs. on-demand in the treatment phase. • Comparison of the UAS7 values during the treatment phase (week 4, treatment with rupatadine 10 mg) between patients treated daily continuously vs. on-demand. • Comparison of the UAS7 values during the treatment phase between patients treated daily continuously vs. on demand during weeks 5 to 10. Comparison of the UAS7 values during treatment with rupatadine 10 mg and treatment with rupatadine 20 mg in patients who received an updosing of rupatadine (paired analysis). • Comparison of the proportion of patients with response (based on the UAS7) during the follow up phase in patients treated daily continuously vs on-demand in the treatment phase and in patients with response vs. non-response at the end of the treatment phase. • Assessment of the safety and tolerability of rupatadine 20 mg (based on the physical examinations, vital signs, clinical observations, monitoring lab, and adverse event reporting);Timepoint(s) of evaluation of this end point: Comparison of the UAS7 values (change from baseline) at the end of the follow-up phase (week 15 and 16) between patients that had been treated daily continuously vs. on-demand in the treatment phase. | — |
Countries
Germany, Spain
Contacts
Public ContactAllergie-Centrum-Charité Department
Charité Universitätsmedizin Berlin
Outcome results
None listed