Status:
COMPLETED
Bilastine Updosing in Chronic Spontaneous Urticaria
Lead Sponsor:
Charite University, Berlin, Germany
Conditions:
Chronic Urticaria
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Chronic spontaneous urticaria (CSU), formerly also known as chronic idiopathic urticaria and chronic urticaria (CU), is one of the most frequent skin diseases. At any time, 0.5-1% of the population su...
Eligibility Criteria
Inclusion
- Male or female aged 18 years and older
- History of active chronic spontaneous urticaria with or without associated angioedema for at least three days per week over the last 6 weeks prior to visit 1. - Urticaria symptoms must comprise wheals and itch
- History of failed treatment with an antihistamine other than bilastine in standard (licensed) dose.
- UAS7 of ≥14 during baseline
- 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
Exclusion
- Chronic spontaneous urticaria patients with a known resistance to bilastine
- Isolated presence or domination of inducible forms of urticaria or cholinergic urticaria (no chronic spontaneous urticaria)
- History of adverse reactions to bilastine or known hypersensitivity to bilastine 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.
- Use of UV-therapy within 28 days prior to visit 1
- 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
- ECG alterations of repolarisation (QTc prolongations \>450ms or increase of QTc \>60ms as compared to the baseline assessment)
- Blood pressure \>180/100 mmHg and/or heart rate \>100/min
- 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)
- 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
- 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).
Key Trial Info
Start Date :
July 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 1 2016
Estimated Enrollment :
30 Patients enrolled
Trial Details
Trial ID
NCT02213367
Start Date
July 1 2014
End Date
March 1 2016
Last Update
August 26 2016
Active Locations (1)
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1
Dpt. of Dermatology and Allergy
Berlin, Germany, Germany, 10117