Patients with Chronic idiopathic urticaria, Eczema/Dermatitis, Prurigo, and Cutaneous pruritus
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. Subjects with itching associated with skin disease.
Exclusion criteria
Exclusion criteria: Subjects with any of the following diseases that may hinder efficacy evaluation. 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 |
|---|---|
| Incidences of adverse events and adverse drug reactions Systolic and diastolic pressure, Pulse, Temperature, Clinical lab, Physical examination. | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in total symptom score (rash score, mean of daytime and night time of itching intensity) from baseline after the treatment. To evaluete the symptoms score by subjects using the patient's diary card. | — |
Outcome results
None listed