Bilastine Updosing - Characterization of Underlying Mechanisms

NCT01271075 | Completed Phase 2 DMC

• 2 other identifiers: BUCUM 20102010-019344-39
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (1)

• The effects of a standard dose (20 mg) and higher than standard doses of bilastine (40 mg and 80 mg) on symptom development in CCU patients

  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).

  6 visits in 12-14 weeks

Secondary Outcomes (2)

• The effects of a standard dose (20 mg) and higher than standard doses of bilastine (80 mg) on mast cell mediator release in CCU patients

  Visit 2 (day 0), visit 3 (day 7) and visit 6 (day 70)

• Safety and tolerability following administration of bilastine to patients with cold contact urticaria

  up to 14 weeks

Study Arms (2)

Bilastine A

ACTIVE COMPARATOR

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

Drug: Bilastine

Bilastine B

ACTIVE COMPARATOR

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

Drug: Bilastine

Interventions

Bilastine DRUG

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

Bilastine A

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Charite University, Berlin, Germany: lead
• Faes Farma, S.A.: collaborator

Study Sites (1)

Charité-Universitätsmedizin Berlin

Berlin, 10117, Germany

Location

MeSH Terms

Conditions

Cold Urticaria; Urticaria

Interventions

bilastine

Condition Hierarchy (Ancestors)

Skin Diseases, Vascular; Skin Diseases; Skin and Connective Tissue Diseases; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Study Officials

• Marcus Maurer, MD

  Charite University, Berlin, Germany

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Karoline Krause, MD

Study Record Dates

• First Submitted: December 30, 2010
• First Posted: January 6, 2011
• Study Start: September 1, 2010
• Primary Completion: August 1, 2011
• Study Completion: December 1, 2011
• Last Updated: May 31, 2012

Record last verified: 2012-05

Locations

DE (1)