Bilastine Updosing - Characterization of Underlying Mechanisms

NCT ID: NCT01271075

Last Updated: 2012-05-31

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-09-30
• Study Completion Date: 2011-12-31

Brief Summary

This is a double-blind, triple cross-over, placebo-controlled study to assess the efficacy, mechanisms, and safety of treatment with the antihistamine bilastine in patients with cold contact urticaria (CCU).

Efficacy is primarily assessed by a change in critical stimulation time thresholds (CSTT) and critical temperature thresholds (CTT) after treatment with different dosages of bilastine (20 mg, 40 mg, 80 mg). Following a baseline period of 2-4 weeks, patients are randomized to either group A or group B. In group A they are given bilastine 20 mg, 40 mg, placebo and bilastine 80 mg for 7 days each followed by a 14-day washout period at a time. In group B they are given bilastine 80 mg, placebo, 40 mg and 20 mg for 7 days each followed by a 14-day washout period at a time. CSTT and CTT testings are performed at each of 6 visits, skin microdialysis for the assessment of mast cell mediators is performed at V2, V3 and V6. Visits for investigator's assessments are scheduled at day -14 to -28, day 0, day 7, day 28, day 49, and day 70. Overall a max. of 20 subjects with cold contact urticaria will be enrolled.

Conditions

Cold Contact Urticaria

Keywords

urticaria; bilastine

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bilastine A

A: Crossover Bilastine 20 mg, Bilastine 40 mg, Placebo, Bilastine 80 mg

Group Type: ACTIVE_COMPARATOR

Bilastine

Intervention Type: DRUG

Single dose, oral, 20 mg, 40 mg, 80 mg each for 7 days

Bilastine B

B: Crossover Bilastine 80 mg, Placebo, Bilastine 40 mg, Bilastine 20 mg

Group Type: ACTIVE_COMPARATOR

Bilastine

Intervention Type: DRUG

Single dose, oral, 20 mg, 40 mg, 80 mg each for 7 days

Interventions

Bilastine

Single dose, oral, 20 mg, 40 mg, 80 mg each for 7 days

Intervention Type: DRUG

Bilastine

Single dose, oral, 20 mg, 40 mg, 80 mg each for 7 days

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Informed consent signed and dated
• Reliable method of contraception for both women of childbearing potential as well as man during the study and 3 months thereafter. A highly effective method of birth control is defined as those which result in a low failure rate (i.e. less than 1% per year) when used consistently and correctly such as implants, injectables, combined oral contraceptives, some IUDs, sexual abstinence or vasectomised partner
• Outpatients with CCU for more than 6 weeks. Urticaria symptoms must comprise wheal and itch.
• Age above 18 years.
• No participation in other clinical trials 1 months before and after participation in this study

Exclusion Criteria

• 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)
• The presence of permanent severe diseases, especially those affecting the immune system, except urticaria and cold urticaria
• The presence of permanent gastrointestinal condition which may influence the oral therapy (chronic diarrhoea diseases, congenital malformations or surgical mutilations of gastrointestinal tract)
• History or presence of epilepsy, significant neurological disorders, cerebrovascular attacks or ischemia
• History or presence of myocardial infarction or cardiac arrhythmia which requires drug therapy
• ECG alterations of repolarisation (QTc prolongations > 450ms)
• Blood pressure >180/100 mmHg and/or heart rate >100/min.
• Evidence of significant hepatic or renal disease (GOT and/or GPT 3 times above the upper reference value, serum creatinine 1.5 times above the upper reference value)
• History of adverse reactions to bilastine or known hypersensitivity to bilastine or its ingredients
• Presence of active cancer which requires chemotherapy or radiation therapy
• Presence of alcohol abuse or drug addiction
• Intake of oral corticosteroids within 14 days prior to screening visit
• Use of depot corticosteroids or chronic systemic corticosteroids within 21 days prior to screening visit
• Use of systemic immunosupressants/immunomodulators like ciclosporine A, dapsone, methotrexate, mycophenolate, chloroquine, and comparable drugs within 28 days prior to screening visit
• Pregnancy or breast-feeding

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Faes Farma, S.A.

INDUSTRY

Sponsor Role: collaborator

Charite University, Berlin, Germany

OTHER

Sponsor Role: lead

Responsible Party

Karoline Krause

Karoline Krause, MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Marcus Maurer, MD

Role: PRINCIPAL_INVESTIGATOR

Charite University, Berlin, Germany

Locations

Charité-Universitätsmedizin Berlin

Berlin, , Germany

Countries

Germany

Other Identifiers

2010-019344-39

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

BUCUM 2010

Identifier Type: -

Identifier Source: org_study_id