临床试验/NCT01043263

NCT01043263已完成2 期

A Phase IIB, Randomized, Double-blind, Two-arm, Multi-center, Placebo-controlled, Study to Assess the Efficacy and Safety of EN3324 (Axomadol) in Subjects With Moderate to Severe Chronic Low Back Pain

Grünenthal GmbH59 个研究点分布在 1 个国家目标入组 236 人开始时间: 2009年12月最近更新: 2015年4月2日

适应症

干预措施

试验速览

阶段: 2 期
状态: 已完成
发起方: Grünenthal GmbH
入组人数: 236
试验地点: 59
主要终点: To evaluate the efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP.

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine the efficacy and safety of EN3324 (axomadol) in subjects with moderate to severe chronic low back pain

详细描述

A phase IIB, randomized, double-blind, two-arm, multi-center, placebo-controlled, study to assess the efficacy and safety of EN3324 (axomadol) in subjects with moderate to severe chronic low back pain

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: Triple (Participant, Investigator, Outcomes Assessor)

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•18 years of age or older
•Are females who are participating abstinence or using a medically acceptable form of contraception or have been post-menopausal, biologically sterile, or surgically sterile for more than 1 year.
•Have been on an unchanged regimen of analgesic medication for chronic low back pain on a daily basis for at least 3 months prior to screening; subjects taking opioids must not exceed total daily doses of 90mg oral morphine equivalent
•Have a history of moderate to severe CLBP

排除标准

•Have evidence of or a history of alcohol and/or drug abuse
•Have pain secondary to a confirmed or suspected neoplasm
•Intend to alter their physical therapy regimen during the study. Subjects who begin or end physical therapy (either home exercises or formal therapy sessions) 2 weeks prior to screening or during the study period will be excluded from the study
•Have a history or physical examination finding, which may confound pain-related data (e.g., fibromyalgia, radiculopathy)

研究组 & 干预措施

EN3324 (axomadol)

Experimental

干预措施: EN3324 (axomadol) (Drug)

Placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

To evaluate the efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP.

时间窗: Change from baseline [Day 0] to final visit [Day 112]

次要结局

To evaluate patient reported outcomes of EN3324 (axomadol) in subjects with moderate to severe CLBP.(Change from baseline [Day 0] to final visit [Day 112])
To evaluate the safety, tolerability and efficacy of EN3324 (axomadol) in subjects with moderate to severe CLBP.(Change from baseline [Day 0] to final visit [Day 112])

研究者

发起方

Grünenthal GmbH

申办方类型

Industry

责任方

Sponsor

研究点 (59)

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