NCT00992576已完成2 期
A Confirmatory, Placebo-controlled, Randomised, Double-blind, Single-dummy, Parallel Group, Ratio-finding Study in Constipated Pain Patients to Establish an Optimal Hydromorphone - Naloxone Ratio With an Improved Bowel Function and a Comparable Analgesic Efficacy Compared to Hydromorphone Alone
Mundipharma Research GmbH & Co KG28 个研究点 分布在 15 个国家目标入组 600 人开始时间: 2010年1月1日最近更新:
适应症
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 600
- 试验地点
- 28
- 主要终点
- Bowel Function Measure Average pain scores
研究概览
简要总结
The purpose of this study is to establish an optimal hydromorphone - naloxone ratio with an improved bowel function for constipated pain patients.
详细描述
Subjects suffering from cancer or non-cancer pain suffering from constipation cased or aggravated by opioids will be randomised to one of four ratios of hydromorphone PR plus naloxone PR or Hydromorphone PR plus placebo to investigate whether a hydromorphone/naloxone combination will lead to comparable analgesia, with a decrease in constipation, and to investigate the optimal dose ratio of hydromorphone and naloxone.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female subjects at least 18 years with a history of non-cancer or cancer pain that requires around-the-clock opioid therapy (8, 24 or 48 mg hydromorphone PR per day for the duration of the study).
- •Subjects with constipation caused or aggravated by opioids
- •Subjects must be willing to discontinue their current opioid analgesic routine, and .
- •current laxative regimen
排除标准
- •Chronic or intermittent pain that results from Fibromyalgia or Rheumatoid Arthritis.
- •Subjects presently taking, or who have taken, naloxone <=30 days prior to the start of the Screening Period.
- •Subjects suffering from diarrhoea.
- •Abnormal liver or kidney function.
结局指标
主要结局
Bowel Function Measure Average pain scores
次要结局
- Bowel Function Measures Rescue medication use
研究者
研究点 (28)
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