Chronic Urticaria - Long Term Assessment of Effects of Rupatadine

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02358265
• Date of registration: 18/12/2014
• Prospective Registration: No
• Primary sponsor: Charite University, Berlin, Germany
• Public title: Chronic Urticaria - Long Term Assessment of Effects of Rupatadine
• Scientific title: 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.
• Date of first enrolment: December 2014
• Target sample size: 192
• Recruitment status: Terminated
• URL: https://clinicaltrials.gov/show/NCT02358265
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Double (Participant, Investigator).
• Phase: Phase 3

Countries of recruitment

Germany

Key inclusion & exclusion 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).



Age minimum: 18 Years
Age maximum: 75 Years
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Urticaria

Intervention(s)

Drug: 10 mg Rupatadine

Drug: 10 mg Rupatadine on demand

Drug: 20 mg Rupatadine

Drug: 10 mg Rupatadine on demand (sham updosing to 20 mg)

Primary Outcome(s)

Urticaria Activity Score (7 day cummulative score - UAS7) [Time Frame: 1 week]

Secondary ID(s)

CU-LATER

Source(s) of Monetary Support

Please refer to primary and secondary sponsors