Evaluation of efficacy and safety of sustained release hydroxyzine vs immediate release hydroxyzine in the treatment of patients with chronic idiopathic urticaria: a randomized, open-label, comparative, multi-centre trial.
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 试验地点
- 9
- 主要终点
- Average change from baseline in following parameters:1. Severity of pruritus over last 24 hours. 2. Rating of number of wheals. 3. Rating of average size of the wheals. 4. Rating of duration of pruritus per day.
研究概览
简要总结
This study is a randomized, open-label, comparative, multi-centre trial comparing the safety and efficacy of sustained release hydroxyzine 75 mg once daily and immediate release hydroxyzine 25 mg three times daily for four weeks in 200 patients with chronic idiopathic urticaria that will be conducted in India only. The primary outcome measures will be evaluation of average change from baseline to end of study in severity of pruritus over last 24 hours, rating of number of wheals, rating of number of size of wheals, rating of number of pruritus per day at baseline visit (day 0), at the end of week 2 and at the end of week 4. The secondary outcomes will be evaluation of rating of sleep disturbance at baseline visit (day 0), at the end of week 2 and at the end of week 4; Clinical global impression on severity (CGI-S) at baseline visit (Day 0) and at the end of week 4; Clinical global impression on improvement (CGI-I) at the end of week 2 and at the end of week 4. The anticipated date of enrollment will be 25th November 2009, subject to registration at CTRI. This is not a global trial.
研究设计
- 分配方式
- Computer generated randomization
- 盲法
- Not Applicable
入排标准
入选标准
- •Male or female patients aged from 18 to 65 years.
- •Patients having minimum 6 weeks history of chronic idiopathic urticaria and were experiencing an active flare.
- •Patient willing to give their informed consent.
排除标准
- •Pregnant, lactating women or women of childbearing age who are not using an acceptable method of birth control.
- •Patients having hypersensitivity to Hydroxyzine.
- •Patients taking pharmacological agents that could interfere with the study drug or interpretation of efficacy.
- •Patients with asthma using leukotriene inhibitors or those requiring chronic inhaled or systemic corticosteroid therapies.
- •Patients with uncontrolled hypertension and/or diabetes.
- •Alcohol abused patients.
- •Patients having porphyria.
- •Patients with renal and hepatic failure.
结局指标
主要结局
Average change from baseline in following parameters:1. Severity of pruritus over last 24 hours. 2. Rating of number of wheals. 3. Rating of average size of the wheals. 4. Rating of duration of pruritus per day.
时间窗: Baseline Visit (day 0), week 2 and week 4
次要结局
- 1. Assessment of rating of sleep disturbance (difficulty in falling asleep due to itch, awakening due to itch, use of sleep medication).2. Average change from baseline in Clinical Global Impression on Severity (CGI-S).3. Evaluation of Clinical Global Impression on Improvement (CGI-I).(1. Baseline Visit (day 0), week 2 and week 42. Baseline Visit (day 0) and week 43. week 2 and week 4)