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 UrticariaTherapeutic area: Diseases [C] - Skin and Connective Tissue Diseases [C17]
- Registration Number
- EUCTR2013-003542-17-DE
- Lead Sponsor
- Charité Universitätsmedizin Berlin
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- All
- Target Recruitment
- 63
• 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 172
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20
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 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).
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method