A phase II/III study of TAC-202 in patients with chronic idiopathic urticaria
- Conditions
- Patients with Chronic idiopathic urticaria
- Registration Number
- JPRN-jRCT2080222523
- Lead Sponsor
- Taiho Pharmaceutical Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Sex
- All
- Target Recruitment
- 300
Subjects with a documented history of chronic urticaria for at least 4 weeks prior to consent acquisition.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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<br>To evaluete the symptoms score by subjects using the patient's diary card.
- Secondary Outcome Measures
Name Time Method General improvement factor<br>To evaluete the General improvement factor by investigator.<br>Incidences of adverse events and adverse drug reactions<br>Systolic and diastolic pressure, Pulse, Temperature, Clinical lab, Physical examination.