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临床试验/NCT01438567
NCT01438567已完成3 期

A Randomised, Double-blind, Double-dummy, Parallel-group Multicenter Study to Demonstrate Improvement in Symptoms of Constipation and Non-inferiority in Analgesic Efficacy in Subjects With Non-malignant or Malignant Pain That Require Around-the-clock Opioid Therapy Taking 50/25 - 80/40 mg Twice Daily as Oxycodone/Naloxone Prolonged Release (OXN PR) Tablets Compared to Subjects Taking 50 - 80 mg Twice Daily Oxycodone Prolonged Release (OxyPR) Tablets Alone

Mundipharma Research GmbH & Co KG1 个研究点 分布在 1 个国家目标入组 270 人开始时间: 2011年9月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
3 期
状态
已完成
发起方
入组人数
270
试验地点
1
主要终点
Bowel function Index (BFI)

研究概览

简要总结

The primary research objective is to demonstrate that subjects taking OXN PR have improvement in symptoms of constipation as measured by the Bowel Function Index (BFI) compared to subjects taking OxyPR tablets alone with cancer and non-cancer related pain without reducing the effectiveness of pain relief as measured by the Brief Pain Inventory (BPI).

详细描述

The study OXN3506 is a multicentre, multiple-dose, randomised, double-blind, double-dummy, active-controlled, parallel-group study in male and female subjects with non-malignant or malignant pain requiring opioids to assess analgesic efficacy and symptoms of constipation secondary to opioid treatment. Subjects will be randomised to two treatment groups and will be treated with OXN PR or OxyPR for up to 5 weeks. The study is composed of three phases, a pre-randomisation phase, a double-blind phase and an extension phase.

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, Care Provider, Investigator)

入排标准

年龄范围
18 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

OXN PR tablets

Experimental

干预措施: oxycodone/naloxone prolonged release (OXN PR) tablets (Drug)

OxyPR tablets

Active Comparator

干预措施: oxycodone prolonged release (OxyPR) tablets (Drug)

结局指标

主要结局

Bowel function Index (BFI)

时间窗: 5 weeks and a 6 month extension

To demonstrate that subjects taking OXN PR have improvement in symptoms of constipation as measured by the Bowel Function Index (BFI) compared to subjects taking OxyPR

次要结局

  • Pain Intensity Scale (PIS)(5 weeks)

研究者

发起方
Mundipharma Research GmbH & Co KG
申办方类型
Industry
责任方
Sponsor

研究点 (1)

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