Open-label, Long-term Extension Study for Treatment of Breakthrough Cancer Pain With BEMA™ Fentanyl
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 5
- 主要终点
- Efficacy Was Not Measured in This Study. The Number of Deaths in the Long Term Follow-up Will be Reported.
研究概览
简要总结
This study is designed to provide continued access to BEMA Fentanyl for those subjects who previously participated in FEN-202 and who wish to continue using BEMA Fentanyl for the treatment of their breakthrough cancer pain.
详细描述
This was an open label, long-term, extension study designed to provide continued access to EMA Fentanyl to those patients with breakthrough cancer pain who were treated for at least 2 weeks in FEN-202, the long term safety study used for worldwide registration. Patients were followed in an outpatient setting. Use of BEMA Fentanyl and occurrence of serious adverse events (SAEs) were monitored. Throughout the study, all patients continued their background opioid regimen and were permitted to use their rescue medication if adequate pain relief was not realized within 30 minutes following application of BEMA Fentanyl.
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
- •previously qualified for and participated in study FEN-202 for at least 2 weeks,
- •wish to continue using BEMA Fentanyl for treatment of breakthrough pain episodes, and
- •provide signed informed consent at screening prior to any study procedures.
排除标准
- •they have developed a new medical condition after initial enrollment in FEN-202 which, in the opinion of the investigator, would preclude safe and appropriate use of BEMA Fentanyl or participation in this study, or
- •there is evidence of improper use of the study drug.
研究组 & 干预措施
BEMA Fentanyl
BEMA Fentanyl
干预措施: BEMA Fentanyl (Drug)
结局指标
主要结局
Efficacy Was Not Measured in This Study. The Number of Deaths in the Long Term Follow-up Will be Reported.
时间窗: 3 years
Efficacy was not measured in this study as the intention was to evaluate long term safety in this population. The number of deaths in the long term follow-up will be reported.
次要结局
未报告次要终点