A 4-week Dose-finding, Multicentre, Double-blind, Randomised, Placebo-controlled, Parallel-group Trial to Assess the Efficacy and Safety of Different Doses of Rupatadine Compared to Placebo in the Treatment of Chronic Idiopathic Urticaria
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- 入组人数
- 248
- 试验地点
- 1
- 主要终点
- Pruritus
研究概览
简要总结
The objective of this study is to evaluate the efficacy and safety of rupatadine for the treatment of CIU symptoms.To assess the clinical efficacy of a dose ranging of rupatadine fumarate (5mg, 10mg, and 20 mg) compared with placebo for relief of CIU symptoms.
详细描述
Objectives: To evaluate the efficacy and safety of rupatadine for the treatment of CIU symptoms.To assess the clinical efficacy of a dose ranging of rupatadine fumarate (5mg, 10mg, and 20 mg) compared with placebo for relief of CIU symptoms.
Methodology: A dose-finding multicentre, double-blind, randomised, placebo-controlled, parallel-group study Number of patients (planned and analysed): 248 patients. 62 patients will be allocated to each treatment group. 283 patients were randomised and analysed.
Diagnosis and criteria for inclusion: Man or woman aged between 12 and 65. Documented history of active CIU (urticaria wheals) with or without an associated angioedema for at least three days per week over the last 6 weeks prior to Day 0 . Active CIU (score ³2 labelled as moderate pruritus) for at least 3 days (not necessarily consecutive days) in the week before inclusion with a total score of active CIU ³6 labelled as moderate pruritus for these 3 days. Results of standard laboratory biochemistry and haematology tests obtained at screening within acceptable limits as assessed by investigator. Patient who signed the informed consent form.
Test product, dose, mode of administration, batch N°: Rupatadine 5,10 and 20 mg tablets; oral dose of 1 tablet/day for 4 consecutive weeks; batch 0102 (France) and batch 0203 (Hungary, Romania and Argentina). Expiry date: 12/2003 (France) and 10/2004 (Hungary, Romania and Argentina).
Duration of treatment: Oral administration of test formulation (5, 10, 20 mg) or placebo daily, for 4 consecutive weeks.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Man or woman aged between 12 and 65
- •Documented history of active CIU (urticaria wheals) with or without an associated angioedema for at least three days per week over the last 6 weeks prior to Day 0
- •Active CIU (score ³2 labelled as moderate pruritus) for at least 3 days (not necessarily consecutive days) in the week before inclusion with a total score of active CIU ³6 labelled as moderate pruritus for these 3 days
- •Results of standard laboratory biochemistry and haematology tests obtained at screening within acceptable limits as assessed by investigator
- •Patient who signed the informed consent form -
排除标准
- •CIU associated to some underlying disease (Hodgkin's disease/vasculitis/lupus erythematous/hepatitis)
- •Patient under any systemic or topical medication for CIU and/or an inferior wash-out period as stated as follows:
- •H1-receptor antagonists: fexofenadine (10 days prior to Day 0), loratadine, cetirizine, hydroxyzine, diphenhydramine, cyproheptadine, etc. (3 days prior to Day 0)
- •H2-receptor antagonists: cimetidine, ranitidine and famotidine (2 days prior to Day 0)
- •H1- and H2-receptor antagonists: doxepin (7 days prior to Day 0)
- •Leukotriene antagonists: zafirlukast and montelukast (4 days prior to Day 0)
- •Corticosteroids: prednisone and methylprednisolone (7 days prior to Day 0)
- •Tricyclic antidepressants: imipramin and amitriptilin (30 days prior to Day 0)
- •The informed consent form must be signed prior to any washout period is set up.
- •Physical urticaria due to cold, heat, and/or sun
- •Cholinergic urticaria
- •Patient taking any potential inhibitors of the CYP3A4 isozyme of cytochrome P450 such as ketoconazole, erythromycin and/or tricyclic antidepressants, e.g. imipramin, amitriptilin, etc.
- •Urticaria due to known aetiology (e.g., medications, insects bites, food, etc)
- •Patient unresponsive to antihistaminic treatment
- •Patient with psychiatric disorders, vascular, hepatic, neurological, endocrine or other major systemic disease
- •Pregnant or lactating female
- •Patient with any heart abnormality of clinical relevance or any pathological changes of the heart rate
- •Patient under any medication which could interfere with drug effect or with interpretation of efficacy parameters
- •Subject handling dangerous machinery or driving as an integral part of his/her occupation
- •Patient with hereditary angioedema or isolated dermographism
- •Patient with disease caused by a parasite
研究组 & 干预措施
rupatadine 20 mg
Once daily/ 28 days
干预措施: Rupatadine Fumarate (Drug)
Placebo
Once daily/ 28 days
干预措施: Rupatadine Fumarate (Drug)
rupatadine 5mg
Once daily/ 28 days
干预措施: Rupatadine Fumarate (Drug)
rupatadine 10 mg
Once daily/ 28 days
干预措施: Rupatadine Fumarate (Drug)
结局指标
主要结局
Pruritus
时间窗: 4 weeks
change in mean pruritus score (MPS) over the 4-week treatment period.
次要结局
- Wheals(4 weeks)
- change in mean total symptoms score (MTSS) over the 4-week treatment period.(4 weeks)
- overall impression(4 weeks)