NCT00487682已完成2 期
Dose-finding Study of ASP2151 in Subjects With Herpes Zoster- A Multicenter, Randomized, Double-blind, Valacyclovir Hydrochloride-controlled, Parallel-group, Comparative Study
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 403
- 主要终点
- To compare the efficacy and safety of ASP2151 with valacyclovir in subjects with Herpes Zoster
研究概览
简要总结
To investigate the efficacy and safety of three different doses of ASP2151, as compared to valacyclovir hydrochloride in subjects with herpes zoster, and to determine the recommended clinical dose.
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
- 20 Years 至 79 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects aged from 20 years to under 80 years on the day informed consent is obtained
- •Subjects to whom the study drugs can be orally administered within 72 hours after the onset of rash due to herpes zoster
- •Subjects in whom protocol-specified observations and assessments are considered possible
排除标准
- •Subjects with extremely compromised immune function due to underlying diseases, treatment with Immunosuppressive agents etc., or radiotherapy
- •Subjects with a serious underlying disease that corresponds to Grade 3 in the Classification Criteria for teh Seriousness of Adverse Drug Reactions
- •Subjects with concurrent malignant tumors, or those with a history of malignant tumors within the past 5 years
研究组 & 干预措施
1
Experimental
ASP2151 low dose
干预措施: ASP2151 (Drug)
2
Experimental
ASP2151 middle dose
干预措施: ASP2151 (Drug)
3
Experimental
ASP2151 high dose
干预措施: ASP2151 (Drug)
4
Active Comparator
Valacyclovir hydrochloride
干预措施: Valacyclovir hydrochloride (Drug)
结局指标
主要结局
To compare the efficacy and safety of ASP2151 with valacyclovir in subjects with Herpes Zoster
时间窗: 3 months
次要结局
- Improvement of cutaneous symptoms and pain(3 months)
研究者
相似试验
终止
1 期
Study Comparing the Safety of ASP2151 to Valacyclovir and Placebo in Healthy VolunteersSafety of ASP2151NCT00870441Astellas Pharma Inc442
已完成
3 期
Phase III Study of ASP2151 in Herpes Zoster PatientsHerpes ZosterNCT01959841Maruho Co., Ltd.751
已完成
1 期
Study to Evaluate the Safety and Pharmacokinetics of ASP2151 in Healthy Non-elderly and Elderly SubjectsHealthy SubjectsNCT02796118Astellas Pharma Inc36
已完成
3 期
Phase III Study of ASP2151 in Herpes Simplex PatientsHerpes SimplexNCT01959295Maruho Co., Ltd.468
已完成
3 期
A Study to Assess the Efficacy and Safety of ASP1941 in Subjects With Type 2 Diabetes Mellitus Who Have Inadequate Glycemic Control on Metformin and SitagliptinType 2 Diabetes MellitusNCT02452632Astellas Pharma Korea, Inc.143