An Open-label, Multi-site Trial to Describe the Safety and Tolerability of Oral Cebranopadol Administered for 26 Weeks in Subjects With Cancer-related Pain Who Have Completed Treatment in the KF6005/07 Trial
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 76
- 试验地点
- 22
- 主要终点
- Number of Participants With Treatment Emergent Adverse Event (TEAEs)
研究概览
简要总结
The purpose of this trial was to find out how well cebranopadol is tolerated and how often, and which, adverse reactions occur when it is taken every day for a longer period of time. In addition, information was collected how cebranopadol affects pain and well-being in patients suffering from cancer-related pain.
详细描述
The trial consisted of 3 phases: Titration Phase, Maintenance Phase, and Follow-Up. The total duration of the trial was approximately 28 weeks for each individual participant, including the Follow-up. The participants received cebranopadol for a maximum of approximately 26 weeks.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent signed indicating that the participant understands the purpose of and procedures required for the trial and is willing to participate in the trial.
- •Participants must be at least 18 years of age at the Enrollment Visit.
- •Women of childbearing potential must have a negative pregnancy test at enrollment and must not be lactating at the Enrollment Visit.
- •Participants must be willing to use medically acceptable and highly effective methods of birth control.
- •Participants who have completed treatment in KF6005/07 and are still in need of around-the-clock pain analgesia with strong opioids.
排除标准
- •The participant has a clinically significant disease or condition other than cancer which in the investigator's opinion may affect efficacy or safety assessments.
- •Known to or suspected of not being able to comply with the protocol and the use of cebranopadol.
- •Participants taking forbidden concomitant medications or not being able to follow the rules of use of concomitant treatment.
- •History of torsade de pointes and/or presence of risk factors for torsade de pointes (e.g., heart failure, hypokalemia, bradycardia).
- •Concurrent participation in another trial (except participation in KF6005/07) or planning to be enrolled in another clinical trial (i.e., administration of experimental treatment in another clinical trial) during the course of this trial, or previous participation in this trial.
- •Employees of the sponsor, investigator, or trial site or family members of the employees, sponsor, or investigator.
研究组 & 干预措施
Cebranopadol
Cebranopadol 200 µg to 1000 µg per taken taken once a day in the morning.
Allowed dose levels in the Maintenance Phase were 200, 400, 600, 800, or 1000 µg per day.
干预措施: Cebranopadol (Drug)
结局指标
主要结局
Number of Participants With Treatment Emergent Adverse Event (TEAEs)
时间窗: Up to 28 weeks (26 weeks of cebranopadol treatment and 2 weeks follow up after the last dose)
The safety of cebranopadol was assessed by the number of participants with treatment emergent adverse events (TEAEs). A TEAE was any adverse event that occurred after the first administration of investigational medicinal product (IMP), i.e., cebranopadol in this study. In addition, pretreatment adverse events which worsened during the treatment period were also considered TEAEs.
次要结局
- Intensity of Treatment Emergent Adverse Events(Up to 28 weeks (26 weeks of cebranopadol treatment and 2 weeks follow-up after the last dose))
- Changes From Baseline in the Average Pain Intensity in the Last Week During the Treatment Period(Baseline Visit (Day 1) to End of Treatment Visit (up to 26 weeks).)