跳至主要内容
临床试验/NCT00125736
NCT00125736已完成4 期

A Double-blind, Comparative Study in Patients With Gastric Ulcer to Evaluate the Efficacy of Combination Use of E0671 and Rabeprazole Sodium

Eisai Co., Ltd.0 个研究点目标入组 520 人开始时间: 2005年8月1日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
520
主要终点
Ratio of S2-stage transition at 8 weeks after the study administration.

研究概览

简要总结

The purpose of this study is to investigate the efficacy and safety of combination use of E0671 and Rabeprazole Sodium in patients with gastric ulcer.

详细描述

The efficacy and safety of E0671 in combination with Rabeprazole Sodium (i.e., 10 mg/day of rabeprazole sodium and 150 mg/day of E0671) will be investigated in patients with gastric ulcer in a multicenter, randomized, double-blind, parallel-group comparative study using a placebo control group (10 mg/day of rabeprazole sodium and placebo for E0671).

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

入排标准

年龄范围
20 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

研究组 & 干预措施

E0671 combination group

Experimental

干预措施: E0671 (Drug)

E0671 combination group

Experimental

干预措施: rabeprazole sodium (Drug)

placebo combination group

Placebo Comparator

干预措施: rabeprazole sodium (Drug)

placebo combination group

Placebo Comparator

干预措施: E0671 placebo (Drug)

结局指标

主要结局

Ratio of S2-stage transition at 8 weeks after the study administration.

时间窗: 8 weeks

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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