Trial record 3 of 3 for:    "Cold contact urticaria"

Bilastine Updosing - Characterization of Underlying Mechanisms (BUCUM)

This study has been completed.
Sponsor:
Collaborator:
Faes Farma, S.A.
Information provided by (Responsible Party):
Karoline Krause, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT01271075
First received: December 30, 2010
Last updated: May 30, 2012
Last verified: May 2012
  Purpose

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.


Condition Intervention Phase
Cold Contact Urticaria
Drug: Bilastine
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double-blind, Triple Cross-over, Placebo-controlled Study to Assess the Efficacy, Mechanisms, and Safety of Treatment With Bilastine 20 mg, 40 mg and 80 mg in Cold Contact Urticaria (CCU)

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • 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 [ Time Frame: 6 visits in 12-14 weeks ] [ Designated as safety issue: No ]
    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).


Secondary Outcome Measures:
  • 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 [ Time Frame: Visit 2 (day 0), visit 3 (day 7) and visit 6 (day 70) ] [ Designated as safety issue: No ]
    Change in mast cell mediator release, including histamine and mast cell-derived cytokines (e.g. IL-1, IL-6, IL-8, IL-13, TNF) after standard dose treatment with bilastine (20 mg) compared to high dose bilastine (80 mg) and baseline.

  • Safety and tolerability following administration of bilastine to patients with cold contact urticaria [ Time Frame: up to 14 weeks ] [ Designated as safety issue: Yes ]
    Safety and tolerability: This includes physical examination, routine safety laboratory assessments, clinical observation, vital signs and adverse event reporting


Enrollment: 20
Study Start Date: September 2010
Study Completion Date: December 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Bilastine A
A: Crossover Bilastine 20 mg, Bilastine 40 mg, Placebo, Bilastine 80 mg
Drug: Bilastine
Single dose, oral, 20 mg, 40 mg, 80 mg each for 7 days
Active Comparator: Bilastine B
B: Crossover Bilastine 80 mg, Placebo, Bilastine 40 mg, Bilastine 20 mg
Drug: Bilastine
Single dose, oral, 20 mg, 40 mg, 80 mg each for 7 days

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01271075

Locations
Germany
Charité-Universitätsmedizin Berlin
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Faes Farma, S.A.
Investigators
Principal Investigator: Marcus Maurer, MD Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: Karoline Krause, Karoline Krause, MD, Charite University, Berlin, Germany
ClinicalTrials.gov Identifier: NCT01271075     History of Changes
Other Study ID Numbers: BUCUM 2010, 2010-019344-39
Study First Received: December 30, 2010
Last Updated: May 30, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
urticaria
bilastine

Additional relevant MeSH terms:
Urticaria
Skin Diseases, Vascular
Skin Diseases
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases

ClinicalTrials.gov processed this record on April 17, 2014