Patients with Chronic idiopathic urticaria
Conditions
Sponsors
Taiho Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Subjects with a documented history of chronic urticaria for at least 4 weeks prior to consent acquisition.
Exclusion criteria
Exclusion criteria: Subjects with any of the following diseases that may hinder efficacy evaluation. Acute eczema/ Chronic eczema/ Contact dermatitis/ Atopic dermatitis/ Nummular eczema/ Autosensitization dermatitis/ Pompholyx eczema/ Asteatotic eczema/ Lichen simplex chronicus/ Acute prurigo/ Subacute prurigo/ Chronic prurigo/ Systemic pruritus/ Regional pururitus/ Vascular edema/ Cholinergic urticarial/ Mechanical urticaria (chill, sunlight, warmth/heat, delayed pressure, water, vibration)/ Aspirin-induced urticarial/ Urticaria associated with vasculitis or collagen disorder/ Urticaria of known origin/ Urticaria related to the thyroid gland/ Urticaria pigmentosa/ Food-dependent motofacient anaphylaxis/ Schnitzler syndrome/ CAPS (cryopyrin associated periodic syndrome)/ Psoriasis/ Ichthyosis Subjects who previously developed anaphylaxis to antihistamine drugs or ingredients in the investigational drug.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in mean of patient's TSS (sum of synthetic score of the rash and itch score (mean of daytime and night time)) from baseline after the treatment To evaluete the symptoms score by subjects using the patient's diary card. | — |
Secondary
| Measure | Time frame |
|---|---|
| General improvement factor To evaluete the General improvement factor by investigator. Incidences of adverse events and adverse drug reactions Systolic and diastolic pressure, Pulse, Temperature, Clinical lab, Physical examination. | — |
Outcome results
None listed