EUCTR2004-004624-13-AT进行中（未招募）1 期
A prospective, multi-centre, multinational, open-label study to investigate the equipotent dose ratio after switching from strong opioids to Transtec® in subjects with pain due to cancer. - Transtec® in Cancer Pain
Barts and The London NHS Trust0 个研究点目标入组 120 人开始时间: 2007年6月14日最近更新:
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 120
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
- •At Visit 1:
- •1. Males and females, 18 years or older.
- •2. Subjects who have given their written informed consent.
- •3. At baseline, female subjects of childbearing potential must be using adequate
- •contraception (i.e. using oral or IM contraception or an IUCD) and must have a negative urine pregnancy test.
- •4. Subjects with moderate to very severe cancer pain, whose pain has been satisfactorily controlled over the preceding two weeks with a stable dose of strong opioid (see footnote 1) of at least 30mg morphine (or equivalent) per day. Satisfactory control” is defined as recalled average daily pain scores as = 4 on an 11-point Numerical Rating Scale (0=no pain, 10=worst pain imaginable) and strong opioid stability as taking a stable daily dose of sustained-release strong opioid (oral or patch) with no more than two doses of immediate release morphine [or equivalent] (or >30% of their 24 hour dose, whichever is greater) for breakthrough on average per day.
- •At Visit 2:
- •1. To be eligible to receive Transtec®, subjects must have continued to obtain satisfactory pain control from the stable dose of strong opioid, with no more than two doses of immediate release morphine [or similar] (or >30% of their stable 24 hour dose, whichever is greater) for breakthrough on average for at least three consecutive days prior to starting on Transtec®.
- •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) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1. Subjects who have previously failed on Transtec®, morphine or Temgesic® therapy.
- •2. Contraindications to Transtec®, morphine or Temgesic® as listed in their respective Summary of Product Characteristics.
- •3. Subjects with documented or suspected alcohol or drug abuse, or who are strongly suspected of having an addictive personality.
- •4. Subjects for whom a treatment is planned within the four week study period that could significantly alter the degree or nature of pain, e.g. radiotherapy, chemotherapy, hormonal therapy, biphosphonate therapy, surgery, nerve block, etc.
- •5. Subjects known to have a condition (e.g. hepatic or renal) that in the investigator’s judgement precludes participation in the study.
- •6. Subjects with a significant psychiatric disorder in the opinion of the investigator or subjects receiving strong anti-psychotic medication.
- •7. Subjects who have received an investigational drug or have used an investigational device in the 30 days prior to study entry.
- •8. Subjects unable to comply with the study assessments and to complete the questionnaires.
- •9. Subjects who have previously been admitted to this study.
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