Double-blind, Randomised, Placebo-controlled, Phase III Study Comparing the Efficacy and Safety of Bilastine 20 mg Once Daily and Levocetirizine 5 mg for the Treatment of Chronic Idiopathic Urticaria
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 522
- 试验地点
- 50
- 主要终点
- Change from baseline, in the am/pm Total Symptom Score (TSS3), over the 28 days of the treatment period according to the patient's assessment in the diary card. (Reflective Symptoms)
研究概览
简要总结
The objective of the study is to evaluate the efficacy and tolerability of Bilastine 20 mg Q.D., compared to Levocetirizine 5 mg Q.D. and placebo for the treatment of Chronic Idiopathic Urticaria.
详细描述
A total of 540 patients with CIU will be enrolled in this pivotal, randomised, multicentre, international, double-blind, placebo and active-comparator controlled, parallel study . Patients will be selected from both public and private clinical practices. The study population includes males and females between 18 and 70 years of age, suffering from CIU for at least 6 weeks prior to entry in the study with no identifiable cause.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •18 to 70 years old.
- •Documented history of CIU for at least 6 weeks prior to entry in the study.
排除标准
- •Dermatological pathology other than chronic idiopathic urticaria.
- •History of autoimmune disorders, Hodgkin's disease, lymphoma, leukemia and generalized cancer.
- •Pregnant or breast-feeding women.
- •Patients who will be operating heavy machinery or need to drive motor vehicles as an essential part of their profession.
- •Patients who have a recent history (within previous 12 months) of drug addiction or alcohol abuse.
- •Patients who are currently participating in or have participated in another clinical trial within the last 3 months
研究组 & 干预措施
1
Bilastine 20 mg
干预措施: Bilastine (Drug)
2
Levocetirizine 5 mg
干预措施: Levocetirizine (Drug)
3
Placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Change from baseline, in the am/pm Total Symptom Score (TSS3), over the 28 days of the treatment period according to the patient's assessment in the diary card. (Reflective Symptoms)
时间窗: 28 days
次要结局
- Reflective and Instantaneous symptoms scores.(28 days)
- QoL questionnaire.(28 days)
- Overall assessment of discomfort caused by CIU.(28 days)
- Investigator's overall clinical impression.(End of study)
- Assessment of the Impact of urticaria on the sleep scale.(28 days)