EFFICACY AND SAFETY OF PROSAPTIDE FOR THE RELIEF OF NEUROPATHIC PAIN

Prosaptide 缓解神经病理性疼痛的功效和安全性

• 批准号: 7380532
• 负责人: DAVID A SIMPSON
• 金额: $ 0.16万
• 依托单位: ICAHN SCHOOL OF MEDICINE AT MOUNT SINAI
• 依托单位国家: 美国
• 财政年份: 2006
• 资助国家: 美国
• 起止时间: 2006-04-17 至 2007-02-28
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/7380532
• 关键词: acetaminophen; analgesics; anticonvulsants; antidepressants; experimental designs; narcotics; pain; placebos

This subproject is one of many research subprojects utilizing the resources provided by a Center grant funded by NIH/NCRR. The subproject and investigator (PI) may have received primary funding from another NIH source, and thus could be represented in other CRISP entries. The institution listed is for the Center, which is not necessarily the institution for the investigator. This will be a randomized, double-blind, placebo-controlled multicenter study design using four dosing levels (2, 4, 8, and 16 mg/day) to evaluate the efficacy and safety of prosaptide for the relief of neuropathic pain associated with HIV-1. An interim analysis will be performed when 200 subjects complete 6 weeks of treatment. Subjects will be washed out of adjuvant pain medications including anticonvulsants, antidepressants, topical analgesics, and short acting-narcotics. Long acting opioid analgesics (maintained at a constant daily dose throughout the study) will be permitted in up to 20% of screened subjects at each study site. Subjects taking long-acting narcotics must have received a constant daily dose for at least 90 days prior to Visit 1. All subjects will receive a supply of acetaminophen 500 mg tablets as rescue medication. Subjects who have intolerable pain despite rescue medication are permitted to discontinue from the study at any time. The double-blind phase will include a 6 week active treatment phase with subjects receiving one of 4 dosing levels of prosaptide or placebo.

该子项目是利用 NIH/NCRR 资助的中心拨款提供的资源的众多研究子项目之一。子项目和研究者 (PI) 可能已从另一个 NIH 来源获得主要资金，因此可以在其他 CRISP 条目中出现。列出的机构是中心的机构，不一定是研究者的机构。这将是一项随机、双盲、安慰剂对照的多中心研究设计，使用四种剂量水平（2、4、8 和 16 毫克/天）来评估 prosaptide 缓解与 HIV 相关的神经性疼痛的功效和安全性-1。当 200 名受试者完成 6 周的治疗后，将进行中期分析。 受试者将不再使用辅助止痛药，包括抗惊厥药、抗抑郁药、局部镇痛药和短效麻醉药。每个研究中心最多 20% 的筛选受试者将允许使用长效阿片类镇痛药（在整个研究期间维持恒定的每日剂量）。服用长效麻醉药的受试者必须在第一次访视之前至少 90 天接受恒定的每日剂量。所有受试者都将收到对乙酰氨基酚 500 毫克片剂作为救援药物。尽管接受了救援药物但仍感到无法忍受疼痛的受试者可以随时停止研究。 双盲阶段将包括为期 6 周的积极治疗阶段，受试者接受 4 种剂量水平的 prosaptide 或安慰剂之一。