NCT01197261已完成2 期
An Exploratory, Randomised, Double-blind, Placebo-controlled, Parallel Group, Pilot Study to Assess the Analgesic Efficacy of Oxycodone/Naloxone Prolonged Release Tablets (OXN PR) Compared to Placebo in Opioid-naive Subjects Suffering From Severe Pain Due to Bladder Pain Syndrome.
Mundipharma Research GmbH & Co KG1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2010年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- To estimate the patient's average pain during treatment with OXN PR compared with placebo
研究概览
简要总结
The study compares the analgesic efficacy of OXN PR vs placebo in opioid-naive subjects suffering from severe pain due to Bladder Pain Syndrome.
详细描述
The study consists of a screening period followed by randomisation of the patients in a 1:1 ratio to OXN PR treatment or placebo treatment in a double blind fashion. The double blind phase will last for 8 weeks.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •History of severe pain due to Bladder Pain Syndrome (BPS) for at least 6 months
- •Subject's treatment of pain due to BPS is insufficient
- •Subjects must not have received opioid containing medication in the last 6 months
排除标准
- •Females who are pregnant or lactating
- •Subjects with any contraindication/history of hypersensitivity to oxycodone, naloxone, paracetamol, related products or other ingredients
- •Subjects with any situation in which opioids are contraindicated like severe respiratory depression with hypoxia and/or hypercapnia, severe chronic obstructive lung disease, cor pulmonale, severe bronchial asthma or paralytic ileus
- •Evidence of clinically significant cardiovascular, renal, hepatic, gastrointestinal or psychiatric disease, as determined by medical history, clinical laboratory tests, ECG results, and physical examination that would place the subject at risk upon exposure to the study medication or that may confound the analysis and/or interpretation of the study results
- •Abnormal aspartate aminotransferase, alanine aminotransferase, or alkaline phosphatise levels (> 3 times the upper limit of normal), gamma glutamyl transpeptidase > 3 times the upper limit of normal
- •Abnormal total bilirubin and/or creatinine level(s)
研究组 & 干预措施
OXN PR
Active Comparator
Oxycodone Naloxone tablets
干预措施: Oxycodone naloxone prolonged release tablets (Drug)
PLA
Placebo Comparator
干预措施: Placebo tablets (Drug)
结局指标
主要结局
To estimate the patient's average pain during treatment with OXN PR compared with placebo
时间窗: 8 weeks
次要结局
- Patient questionnaires(8 weeks)
研究者
研究点 (1)
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