METHOD FOR THE ANALYSIS OF PAIN CLINICAL TRIALS

疼痛临床试验的分析方法

• 批准号: 6173343
• 负责人: JOHN T FARRAR
• 金额: $ 16.7万
• 依托单位: UNIVERSITY OF PENNSYLVANIA
• 依托单位国家: 美国
• 财政年份: 1997
• 资助国家: 美国
• 起止时间: 1997-09-30 至 2002-09-29
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6173343
• 关键词: amitriptyline; analgesia; analgesics; antidepressants; cancer pain; clinical research; clinical trial phase I; computer simulation; desipramine; dosage; drug screening /evaluation; human subject; human therapy evaluation; neurotransmitter antagonist; opiate alkaloid; questionnaires; tricyclic antidepressant

The application proposes to: 1) develop a computer simulation of idealized drug dose (input) data and patient response measures (output); the doses are of opiate analgesic and/or tricyclic adjunctive drugs; the output is to be assessed by questionnaire instruments, soon to be tested; 2) analyze the results of an ongoing trail, comparing amitriptyline and desipramine adjunctive analgesia in cancer pain patients treated with opiates; and 3) conduct a prospective, blinded, randomized study of veniafaxine versus placebo adjunctive treatment (to opiate analgesia) in cancer pain patients; the opioid treatment regiment will first have been stabilized for each patient. The veniafaxine (or placebo, benztropine) dose will be titrated upward, over time, unless limited by side effects. Patients will be followed for ten weeks, their condition being scored at either daily, weekly or bi-weekly intervals by the defined questionnaire battery. Over this time period, not only will adjunct does be varied upward or downward, depending on the complaint of side effect, whereas the opiod dose will be varied in response to pain complaint.

该应用程序提议：1）开发计算机模拟 理想化的药物剂量（输入）数据和患者反应措施 （输出）;剂量是阿片类镇痛和/或三环辅助的 毒品；输出将通过问卷仪器评估，很快 要测试； 2）分析正在进行的步道的结果，比较 癌症疼痛中的阿米替林和去丙胺辅助镇痛 接受鸦片治疗的患者； 3）进行前瞻性，盲人， 静脉融合与安慰剂辅助治疗的随机研究 （鸦片镇痛）在癌症疼痛患者中；阿片类药物治疗 军团将首先为每个患者稳定。 这 韦尼亚法辛（或安慰剂，苯甲衣）剂量将被滴定， 随着时间的流逝，除非受到副作用的限制。 将遵循患者 十个星期，他们的病情在每天，每周或 定义的问卷电池每两周间一次。 为此 时间段，不仅会将辅助的变化或 向下，取决于副作用的抱怨，而 OPIOD剂量会因疼痛抱怨而变化。