JPRN-jRCTs051180105已完成3 期
Efficacy of bilastine as histamine H1 receptor antagonist on switching treatment in patients with chronic spontaneous urticaria: A multicenter, open-label, randomized, parallel, comparison study - H1-SWITCH
Fukunaga Atsushi0 个研究点目标入组 129 人开始时间: 2019年3月8日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 129
研究概览
简要总结
The primary endpoint, the mean TSS at Day5-7 after the start of administration, was smaller than the non-inferiority margin of 0.8, demonstrating the non-inferiority of the bilastine switching group to the 2-fold dose H1RA group. No difference was observed between the two groups in the secondary endpoints of JESS, DLQI, and UAS7.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 20age old 至 ot applicable（—）
- 性别
- All
入选标准
- •(1)Patients aged 20 years or older at the time of acquisition consent
- •(2)Patients diagnosed with chronic urticaria for which second-generation non-sedative or mild-sedative antihistamines (regular dose) is not sufficiently effective at the time of acquisition consent.
- •(3)Patients with chronic urticaria with pruritus or wheal continuation despite continued treatment with unchanged second-generation non-sedating or mild-sedative antihistamines (regular dose) for more than 1 week prior to obtaining consent.
- •(Second generation non-sedating antihistamines include fexofenadine hydrochloride, levocetirizine hydrochloride, olopatadine hydrochloride, bepotastine besylate, loratadine, cetirizine hydrochloride, epinastine hydrochloride, ebastine, lupantadine fumarate)
- •(4)Patients with UCT score of 11 or less on screening phase
- •(5)Patients who obtained document consent regarding their own voluntary participation in this clinical study
- •(6)Even if symptoms (pruritus or wheal) improve while taking the test drug or control drug, patients who can take the test drug or control drug for 7 days.
排除标准
- •(1)Patients with urticaria, other than chronic spontaneous urticaria, with an identifiable trigger/cause. If triggering factors are specified and the site or timing of onsets of symptom due to the factor can be clearly distinguished from chronic spontaneous urticaria which is the target disease of this clinical study, it does not conflict with the exclusion criteria.
- •(2)Patients with a skin disease accompanied by chronic pruritus other than chronic urticaria. (eczema, contact dermatitis, atopic dermatitis)
- •(3)Patients with hypersensitivity for bilastine
- •(4)Patients with chronic, uncontrolled medical condition that may increase the risk of research subjects participating in clinical research with the judgement of research investigator or research team physicians.
- •(5)Pregnant or lactating women
- •(6)Patients treated with bilastine, adrenocorticosteroid, or cyclosporine within 4 week prior to obtaining consent. Patients treated with first generation antihistamines, H2 receptor antagonists, or anti-leukotriene drugs within one week prior to obtaining consent. However, the use of external medicine is permitted.
- •(7)Patients with chronic spontaneous urticaria treated with omalizumab in the past.
- •(8)In addition, patients judged inappropriate by research investigator or research team physicians.
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