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.

该申请建议：1）开发计算机模拟 理想的药物剂量（输入）数据和患者反应测量 （输出）;剂量为阿片类镇痛药和/或三环类辅助药 毒品；很快将通过调查问卷工具对产出进行评估 待测试； 2）分析正在进行的试验的结果，比较 阿米替林和地昔帕明辅助镇痛治疗癌性疼痛 使用阿片类药物治疗的患者； 3）进行前瞻性、盲法、 veniafaxine 与安慰剂辅助治疗的随机研究 （鸦片镇痛）癌症疼痛患者；阿片类药物治疗 首先，每位患者的治疗方案都会得到稳定。 这 veniafaxine（或安慰剂，苯甲托品）剂量将向上滴定， 随着时间的推移，除非受到副作用的限制。 患者将被跟踪 在十周内，他们的状况每天、每周或 按定义的问卷电池每两周间隔一次。 对此 时间段，不仅附加物会向上变化或 向下，取决于副作用的抱怨，而 阿片剂量将根据疼痛症状而变化。