NCT01271075

Bilastine Updosing - Characterization of Underlying Mechanisms

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)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 20 (actual)
• Sponsor: Charite University, Berlin, Germany · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
DRUG	Bilastine	Single dose, oral, 20 mg, 40 mg, 80 mg each for 7 days
DRUG	Bilastine	Single dose, oral, 20 mg, 40 mg, 80 mg each for 7 days

Timeline

• Start date: 2010-09-01
• Primary completion: 2011-08-01
• Completion: 2011-12-01
• First posted: 2011-01-06
• Last updated: 2012-05-31

Locations

1 site across 1 country: Germany