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临床试验/NCT01006356
NCT01006356已完成4 期

Cancer Pain Management With Hydromorphone HCl ORal Osmotic System in Korean Cancer Patient: Evaluation of Its Clinical Usefulness in Reduction of Breakthrough Pain Medication Frequency

Janssen Korea, Ltd., Korea0 个研究点目标入组 141 人开始时间: 2008年10月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
141
主要终点
Percentage of Participants With Dosing Frequency of Analgesics for Treating Breakthrough Pain

研究概览

简要总结

The purpose of this study is to evaluate the clinical efficacy of hydromorphone hydrochloride (HCl) Oral Osmotic System (OROS) by assessing the extent of reduction of medication frequency for the management of breakthrough pain after the administration of hydromorphone HCl OROS in Korean cancer participants.

详细描述

This is an open-label (all people know the identity of the intervention), multi-center (conducted in more than 1 center), prospective (study following participants forward in time) study. The total duration of study will be 3 weeks. The study consists of 2 periods and 4 visits: screening period (1 week; Visit 1) and treatment period (2 weeks; Visit 2, 3 and 4). During screening period at Visit 1, potential participants will receive previously administered oral opioid analgesic until the second visit and with immediate-release opioid analgesic whenever breakthrough pain is present. During treatment period, from second visit to the fourth visit, participants will receive the hydromorphone HCl OROS once daily for 2 weeks. At Investigator's discretion, participants completing 2 weeks of treatment with study drug could be enrolled into the extension phase of 12-weeks. The dose of study drug is flexible and will be increased or decreased based on the frequency of immediate-release opioid analgesic doses needed to manage pain. At second visit, initial dose of hydromorphone will be determined according to the equivalent analgesic effect conversion tablet (oxycodone 10 milligram [mg] twice daily is equal to hydromorphone HCl 8 mg once daily). The Investigator will increase a participant's daily dose if more than 3 breakthrough pain episodes require rescue medication within a 24 hours period. Participants' safety will be monitored throughout the study.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

入排标准

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

入选标准

  • Cancer participants administering only strong oral opioid analgesic for cancer pain control
  • Participants administering short-acting narcotic analgesics at least twice daily due to breakthrough pain for 3 days just before Visit 2 (Day 1)
  • Participants sufficiently capable of complying overall study requirements including participant diary for pain at the discretion of the Investigators
  • Abstinent or surgically sterile female participants

排除标准

  • Participants with cancer pain who are potentially unresponsive to narcotic analgesics
  • Participants with presence or history of drug or alcohol abuse within the past 6 months
  • Participants with hypersensitivity to hydromorphone HCl
  • Participants with history of colectomy (surgery to remove part or all of the colon)
  • Participants with severe digestive tract disease which might interfere with oral analgesic effects, such as dysphagia (trouble swallowing), vomiting, no bowel movement, ileus, and severe enterostenosis that can influence absorption and passing through of oral medication

研究组 & 干预措施

Hydromorphone hydrochloride (HCl) oral osmotic system (OROS)

Experimental

Hydromorphone HCl OROS 8 milligram (mg) once daily for 2 weeks.

干预措施: Hydromorphone HCl OROS (Drug)

结局指标

主要结局

Percentage of Participants With Dosing Frequency of Analgesics for Treating Breakthrough Pain

时间窗: Day 15

Percentage of participants with decrease in dosing frequency by 33 percent or more in breakthrough pain (acute pain that comes on rapidly despite the use of pain medication) was determined at final visit (Day 15) compared to Baseline (Day 1 - when the administration of study drug was started).

次要结局

  • Pain Intensity Score(Day 3 and Day 13)
  • Global Assessment of Overall Efficacy of Study Drug by Investigator(Day 15)
  • Global Assessment of Overall Efficacy of Study Drug by Participant(Day 15)
  • Participant's Preferences Along With Reasons(Day 15)
  • Frequency of Experiencing Breakthrough Pain(Day 1 and Day 15)
  • Change From Baseline in Korean - Brief Pain Inventory (K-BPI) Score at Day 15(Baseline and Day 15)
  • Number of Participants With Clinical Global Impression - Improvement (CGI-I) Score(Day 15)
  • European Organisation for Research and Treatment of Cancer Quality of Life (EQRTC QLQ-C30) Score(Day 1 and Day 15)

研究者

申办方类型
Industry
责任方
Sponsor

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