A multi-center, randomized, double blind, dose escalating phase III study on the efficacy, safety and long term outcome of continuous vs. on demand treatment of chronic spontaneous urticaria with rupatadine

• Conditions: Chronic Spontaneous Urticaria; Therapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]

• Registration Number: EUCTR2013-003542-17-ES
• Lead Sponsor: Charité Universitätsmedizin Berlin

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2014-10-16
• Last Update Posted: 10 November 2014

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 192

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 < 1) a woman will be considered not of childbearing potential if she is post-menopausal for > 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 152
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

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 (<50 bpm)
-ECG alterations of repolarisation (QTc prolongations >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 glucose-galactose 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).

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified