An exploratory study to evaluate the efficacy and safety of bilastine in reducing pruritus in patients with chronic spontaneous urticaria and other skin diseases.

FAES FARMA, S.A.0 sites115 target enrollmentJune 6, 2016

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: Chronic spontaneous urticaria and the following skin disorders:1 - Eczema/dermatitis (acute eczema, chronic eczema, contact dermatitis, atopic dermatitis, nummular eczema, autosensitisation dermatitis, dyshidrotic eczema, asteatotic eczema, lichen simplex chronicus).2 - Prurigo (acute prurigo, subacute prurigo, chronic prurigo).3 - Cutaneous pruritus (systemic cutaneous pruritus, local cutaneous pruritus).
Sponsor: FAES FARMA, S.A.
Enrollment: 115
Status: Active, not recruiting
Last Updated: 9 years ago

No summary available.

Registry

who.int

Start Date

June 6, 2016

End Date

TBD

Last Updated

9 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

All

Sponsor

•General inclusion criteria:
•\- Patients between 18 and 74 years of age at the time informed consent is obtained who can visit the participating medical institution as outpatients (either male or female).
•\- Patients who are able to provide written informed consent by themselves.
•Enrollment:
•\- Patients who have not responded to the use of placebo during the run\-in period (non\-responder is defined as: sum itch/pruritus score first 3 days – sum itch/pruritus score last 3 days \<2\).
•\- Patients will be able to record appropriately on the patient diary during last 3 days before enrollment day and have more than 80% of recording rate of patient diary in run\-in period.
•Related\-disease inclusion criteria:
•For the group of patients with chronic spontaneous urticaria:
•\- Patients with a documented history of chronic spontaneous urticaria for at least 6 weeks prior to consent signature.
•Enrollment:

•The following exclusion criteria apply for all patients:
•S1\) Patients with or who have had malignant tumors or patients with severe concomitant diseases including liver disease (liver failure, fulminant hepatitis, cirrhosis, etc.), kidney disease (nephrotic syndrome, acute renal failure, uremia, etc.), thyroid diseases (uncontrolled hyperthyroidism or hypothyroidism), heart disease (congestive cardiac failure, myocardial infarction, sinus tachycardia, atrial fibrillation, atrial flutter, severe arrhythmias, etc.), haematological disease (pancytopenia, leukopenia, etc.), psychiatric/neurological disorders (schizophrenia, dementia, etc.), and autoimmune disease (collagen disorder, etc).
•S2\) Patients with previous experience of non\-response to antihistamines.
•S3\) Patients with fungal, bacterial or viral skin infections (excluding those that do not interfere with the efficacy evaluation).
•S4\) Patients with any of the following diseases that may interfere with efficacy evaluation:
•?Severe dermographism
•?Cholinergic urticaria
•?Physical urticaria
•?Angiitis or collagen disease induced urticaria
•?Paraneoplastic urticaria