JPRN-jRCT2080222478
Unknown
Phase 3
A phase III long-term study to evaluate the safety and efficacy of TAC-202 in patients with chronic idiopathic urticaria and pruritus accompanied by skin diseases
Overview
- Phase
- Phase 3
- Intervention
- Not specified
- Conditions
- Patients with Chronic idiopathic urticaria, Eczema/Dermatitis, Prurigo, and Cutaneous pruritus
- Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Enrollment
- 170
- Last Updated
- 2 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility 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
- •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.
Outcomes
Primary Outcomes
Not specified
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