A phase III study of TAC-202 in patients with chronic idiopathic urticaria and pruritus accompanied by skin diseases

Phase 3

• Conditions: Patients with Chronic idiopathic urticaria, Eczema/Dermatitis, Prurigo, and Cutaneous pruritus

• Registration Number: JPRN-jRCT2080222478
• Lead Sponsor: Taiho Pharmaceutical Co., Ltd.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2014-05-07
• Last Update Posted: 17 October 2023

Recruitment & Eligibility

• Sex: All
• Target Recruitment: 170

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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Incidences of adverse events and adverse drug reactions<br>Systolic and diastolic pressure, Pulse, Temperature, Clinical lab, Physical examination.

Secondary Outcome Measures

Name	Time	Method
Change in total symptom score (rash score, mean of daytime and night time of itching intensity) from baseline after the treatment.<br>To evaluete the symptoms score by subjects using the patient's diary card.