Chronic Urticaria - Long Term Assessment of Effects of Rupatadine

• Status: Terminated
• Trial end date: 2018-06-15
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Charite University, Berlin, Germany
• Treatments: Cyproheptadine

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 < 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 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).