EUCTR2006-005403-34-IT进行中（未招募）不适用
An Open-Label Study Investigating Long-Term Safety andTolerability of Nasalfent (Fentanyl Citrate Nasal Spray) in theTreatment of Breakthrough Cancer Pain (BTCP) in SubjectsTaking Regular Opioid Therapy - ND
ARCHIMEDES0 个研究点目标入组 500 人开始时间: 2007年5月4日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 500
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •If enrolled in Studies CP043/06/FCNS or CP044/06/FCNS:
- •a. Subject successfully completed the study (including the return of any
- •remaining drug supplies and successful completion of the subject
- •b. Subject is continuing to experience episodes of breakthrough pain
- •that were adequately controlled with a designated dose of Nasalfent
- •in Studies CP043/06/FCNS or CP044/06/FCNS.
- •c. The subject?s medical condition is such that the subject continues to
- •meet the other inclusion/exclusion criteria listed.
- •If newly enrolled into this study:
- •Male or female subjects, aged 18 years and older, with a malignancy
- •who are taking regular, 24-hour medication (at least 60 mg oral
- •morphine or equivalent opioid) for his or her underlying persistent
- •cancer pain and who typically have 1 to 4 episodes of BTCP per day
- •are eligible for participation
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range
排除标准
- •Subjects with uncontrolled or rapidly escalating pain or whose condition
- •is unstable or rapidly deteriorating should not be enrolled. Additionally,
- •subjects with a medical condition (i.e., respiratory, cardiac, hepatic or
- •renal, neurological, psychiatric) that would make them unsuitable for
- •the study should not be enrolled. Subjects with a history of alcohol or
- •substance abuse are not eligible.
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