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临床试验/jRCT2031200418
jRCT2031200418已完成不适用

A phase 2a study of S-637880 in patients with neuropathic low back pain

Shionogi & Co., Ltd.0 个研究点目标入组 160 人开始时间: 2021年3月11日最近更新:

试验速览

阶段
不适用
状态
已完成
入组人数
160
主要终点
weekly mean of maximum daily pain intensity

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomized Controlled Trial
干预模型
Parallel Assignment
主要目的
Treatment Purpose
盲法
Double Blind

入排标准

年龄范围
20age old over 至 75age old not(—)
性别
All

入选标准

  • Patients who meet the following criteria:
  • Patients with chronic pain located in the posterior aspect of the trunk and between the twelfth rib and the inferior end of the gluteal fold
  • Patients whose average daily pain intensity are 4 or higher on Visit 1
  • Patients whose weekly mean of average daily pain intensity are 4 or higher and less than 10 for 7 days including Visit 2 (Day 1) on Visit 2

排除标准

  • Patients who are considered to have primary pain other than low back and leg pain or patients with neuropathic pain other than low back and leg pain

结局指标

主要结局

weekly mean of maximum daily pain intensity

时间窗: 8 weeks

Changes from the baseline to 8 weeks administration as measured by the Numerical Rating Scale

次要结局

未报告次要终点

研究者

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