止吐福沙匹坦治疗恶心和呕吐：随机对照试验 (AFTR NV RCT)
2026年5月14日 更新者：Montefiore Medical Center
研究小组提出了一项随机、双盲、随机对照试验，以实现以下目标：确定福沙匹坦与标准止吐药昂丹司琼相比的相对疗效和不良事件概况。
福沙匹坦及其活性代谢物阿瑞匹坦是一类相对较新的止吐药，通过阻断神经激肽 (NK-1) 专门在中枢神经系统中发挥作用，神经激肽是呕吐反射中枢介导方面的关键信号分子。
目前，福沙匹坦和阿瑞匹坦都只有两种美国食品药品监督管理局（USFDA）批准的恶心和呕吐适应症：化疗引起的和术后引起的。
神经激肽抑制剂非常有效且通常耐受性良好。
因此，对于数百万在急诊室寻求治疗的恶心和呕吐患者来说，此类药物可能是更合适的药物。
静脉注射福沙匹坦在几分钟内即可转化为活性代谢物阿瑞匹坦，并且此时的采购成本要低得多。
功效分析的结果是在研究药物给药后 2 小时内不需要额外的药物来治疗恶心和呕吐。
耐受性分析的主要结果是用药后 2 小时内出现任何新症状。
研究概览
详细说明
恶心和呕吐 (NV) 是常见且相互关联的病症。 大约 50% 的成年人在某一年经历过恶心，而 30% 的成年人在同一时期经历过呕吐。 在有 NV 症状的人群中，25% 的患者在任何医疗保健机构寻求护理。 医疗保健利用项目 (HCUP) 数据表明，美国每年有近 900 万患者在急诊科 (ED) 寻求 NV 护理。
止吐药用于治疗 NV。 目前在急诊室用于治疗 NV 的止吐药并不总是在首次剂量时起作用，并且由于其作用机制位于中枢神经系统呕吐反射途径之外，因此具有大量副作用。 这些药物包括昂丹司琼、异丙嗪、甲氧氯普胺、奥氮平、氟哌啶醇。 这些副作用中最主要的是称为 QT 段的心脏电信号的改变，它代表心室收缩和舒张的持续时间。 常用止吐药可延长 QT 段，这通常是导致死亡的心律失常的前奏。 因此，NV 患者通常需要长期住院 (LOS)，包括静脉输液支持治疗或使用可加剧心律失常发生的药物进行经验性治疗。 对于繁忙的急诊科 (ED) 来说，这是一个问题，他们需要努力提高患者吞吐量，以便在全国医院床位供应不足的环境中适当跟上患者数量。
福沙匹坦及其活性代谢物阿瑞匹坦是一类相对较新的止吐药，通过阻断神经激肽 (NK-1) 专门在中枢神经系统中发挥作用，神经激肽是呕吐反射中枢介导方面的关键信号分子。 目前，福沙匹坦和阿瑞匹坦都只有两种美国食品药品监督管理局（USFDA）批准的恶心和呕吐适应症：化疗引起的和术后引起的。 神经激肽抑制剂非常有效且通常耐受性良好。 因此，对于数百万在急诊室寻求治疗的恶心和呕吐患者来说，此类药物可能是更合适的药物。 静脉注射福沙匹坦在几分钟内即可转化为活性代谢物阿瑞匹坦，并且此时的采购成本要低得多。
研究类型
介入性
注册 (估计的)
200
阶段
- 阶段2
- 第三阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Mustfa K Manzur, MD MPH MS
- 电话号码：718-920-6626
- 邮箱：mmanzur@montefiore.org
学习地点
-
-
New York
-
The Bronx、New York、美国、10467
- 招聘中
- Montefiore Medical Center (Montefiore and Weiler EDs)
-
接触：
- Mustfa K Manzur, MD
- 电话号码：718-920-6626
- 邮箱：mmanzur@montefiore.org
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
纳入标准：
- 年满 18 岁的成年人
- 出现国际疾病分类 (ICD-10) 定义或治疗临床医生确定的恶心和/或呕吐
排除标准：
- 怀孕、想要怀孕或哺乳期
- 筛查前使用止吐剂或静脉输液
- 心动过缓（心率低于 60 bpm）
- QTc 延长（大于 460 毫秒）
- 不熟悉英语或西班牙语
- 精神状态改变
- 失智
- 缺乏后续沟通电话
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：四人间
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：研究性干预
福沙匹坦 150mg IV，持续 15 分钟
|
福沙匹坦 150mg IV，持续 15 分钟
|
|
有源比较器：标准护理干预
Ondansetron 4mg IV 给药时间超过 15 分钟
|
Ondansetron 4mg IV 给药时间超过 15 分钟
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Relief from NV
大体时间：Within 2 hours of medication administration
|
Relief from nausea and vomiting will be determined by the intensity of nausea reported by participants following administration of antiemetic.
Intensity of nausea will be reported as either "None," "Mild," "Moderate," or "Severe."
Relief of nausea and vomiting requires a patient to present with a nausea intensity of either "Severe" or "Moderate," which is then reduced by treatment to at least "Mild" or "None," within two hours of medication administration, without the use or rescue medication.
The number/percentage of participants who achieve relief from NV will be summarized by study arm.
|
Within 2 hours of medication administration
|
|
Occurrence of any treatment-related adverse event
大体时间：2 hours following medication administration
|
The primary safety/tolerability outcome for this study is the occurrence of any treatment related adverse event (TRAE) at 2 hours of medication administration.
TRAEs - not including underlying pathology causing NV - and including, but not limited to: appendicitis, small bowel obstruction, constipation, gastroparesis, gastroenteritis, gastritis, will be summarized by study arm
|
2 hours following medication administration
|
|
Requirement for additional medication
大体时间：2 hours following medication administration
|
Requirement of any additional medication specifically for treatment of NV at 2 hours of medication administration; the use of rescue medications to treat persistent NV, or other medications such as additional doses or use of adjunct medications will be recorded.
The number/percentage of patients who require additional medication will be summarized by study arm.
|
2 hours following medication administration
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Freedom from nausea and vomiting (NV)
大体时间：2 hours following medication administration
|
Freedom from nausea and vomiting (NV) will be determined by the intensity of nausea reported by participants following administration of antiemetic.
Intensity of nausea will be reported as either "None," "Mild," "Moderate," or "Severe."
Sustained freedom from nausea and vomiting requires a patient to present with a nausea intensity of either "Severe" or "Moderate," which is then reduced by treatment to "None" within two hours of medication administration.
The number/percentage of patients with freedom from nausea/vomiting (NV) will be measured every 15 minutes for the first 2 hours.
The number/percentage of patients with freedom from NV at 2 hours will be summarized by study arm.
|
2 hours following medication administration
|
|
Sustained Relief from nausea and vomiting (NV) (at 24 hours)
大体时间：At 24-hours following medication administration
|
The number/percentage of patients demonstrating relief from nausea/vomiting (NV) will be measured every 15 minutes for the first 2 hours (for assessment of the primary outcome), then during every hour up to the end of the follow up period at 24 hours.
Relief from NV is defined as achieving a level of relief of either "Mild" or None" at 2 hours and maintaining that level of "Mild" or "None" for the entire 24-hour period following medication administration, without use of rescue medication.
The number/percentage of participants who achieve relief from NV will be summarized by study arm.
|
At 24-hours following medication administration
|
|
Sustained NV Freedom (at 24 hours)
大体时间：At 24- hours following medication administration
|
Sustained freedom from nausea and vomiting (NV) will be determined by the intensity of nausea reported by participants following administration of antiemetic.
Intensity of nausea will be reported as either "None," "Mild," "Moderate," or "Severe."
Sustained freedom from nausea and vomiting requires a patient to present with a nausea intensity of either "Severe" or "Moderate," which is then reduced by treatment to "None" within two hours of medication administration (corresponding secondary outcome), and maintained at this level (i.e., "None") for the entire 24-hour follow-up period, without the use or rescue medication.
The number/percentage of participants who achieve sustained freedom from NV will be summarized by study arm.
|
At 24- hours following medication administration
|
|
Disposition Plan
大体时间：4 hours following medication administration
|
A disposition determination plan will be documented at 4 hours.
Patients will be categorized as either having been either "admitted," "discharged," or status "yet to be determined."
Categorical data will be summarized by study arm.
|
4 hours following medication administration
|
|
Patient Medication Preference for subsequent episode of NV
大体时间：24 hours following medication administration
|
Medication preference will be assessed based on patient's preference for receiving the same antiemetic medication as administered for a subsequent episode of nausea and vomiting.
Binary ("Yes" for having the same medication administered, "No" for request of a different medication) responses of patient preference will be summarized by study arm.
|
24 hours following medication administration
|
|
Emergency Department (ED) Length of Stay (LOS)
大体时间：From initial presentation to disposition in ED, approximately 4 hours
|
ED LOS will be defined as the interval of time from initial presentation to final disposition in the ED, will be determined.
Mean LOS results will be summarized by study arm.
|
From initial presentation to disposition in ED, approximately 4 hours
|
其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Severity of Nausea
大体时间：24 hours (measured every 15 minutes for the first 2 hours, then hourly after that until disposition; reassessed at 24 hours)
|
Mean severity of nausea scores will be evaluated and summarized based on a visual analogue scale from 0 to 100 (0 = no nausea, 100 = worst nausea possible) such that higher scores are associated with more severe nausea.
Results will be summarized by study arm.
|
24 hours (measured every 15 minutes for the first 2 hours, then hourly after that until disposition; reassessed at 24 hours)
|
|
Functional disability
大体时间：24 hours (assessed prior to receiving intervention, at 2 hour point after receiving intervention, and 24 hours after intervention)
|
Patient reported functional disability will be assessed.
Functional disability will be categorized as either "Severe," "Moderate," "Mild," or "Not impaired."
Categorical variables will be summarized by study arm using descriptive statistics.
|
24 hours (assessed prior to receiving intervention, at 2 hour point after receiving intervention, and 24 hours after intervention)
|
|
Number of Vomiting Episodes
大体时间：24 hours following medication administration
|
The mean number of vomiting episodes per patient will be determined and summarized by study arm.
|
24 hours following medication administration
|
|
Need for rescue antiemetic medication
大体时间：2 hours (assessed at the 2 hour mark after administration of the intervention)
|
Binary outcome for needing or not needing additional dosing of antiemetic medication to treat nausea will be determined.
Results will be summarized by study arm.
|
2 hours (assessed at the 2 hour mark after administration of the intervention)
|
|
Number of Patients Requiring Hospitalization
大体时间：24 hours
|
The number/percentage of patients who require hospitalization within 24 hours due to NV symptoms will be determined.
Results will be summarized by study arm.
|
24 hours
|
|
Fluid Treatment
大体时间：4 hours
|
The percentage of patients treated with IV fluids will be determined.
Results will be summarized by study arm.
|
4 hours
|
|
Mean Fluid Volume
大体时间：4 hours
|
The mean per patient volume of IV fluids administered will be summarized by study arm.
|
4 hours
|
|
QTc Interval (QT interval corrected for heart rate)
大体时间：Prior to Intervention and at disposition, approximately 2 hours
|
Mean QTc durations, as calculated from ECG readings administered prior to receiving intervention and at disposition, will be determined.
Prolonged QT interval is commonly associated with antiemetics and can often be a prelude to cardiac dysrhythmias associated with mortality.
Mean QTc durations will be summarized by study arm.
|
Prior to Intervention and at disposition, approximately 2 hours
|
|
Revisit Rate
大体时间：24 hours
|
Revisit rate will be assessed as the number/percentage of participants requiring a revisit to the Emergency department for NV.
Results will be summarized by study arm.
|
24 hours
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 首席研究员：Benjamin W Friedman, MD MS、Montefiore Medical Center
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- Furyk JS, Meek RA, Egerton-Warburton D. Drugs for the treatment of nausea and vomiting in adults in the emergency department setting. Cochrane Database Syst Rev. 2015 Sep 28;2015(9):CD010106. doi: 10.1002/14651858.CD010106.pub2.
- Aapro M, Carides A, Rapoport BL, Schmoll HJ, Zhang L, Warr D. Aprepitant and fosaprepitant: a 10-year review of efficacy and safety. Oncologist. 2015 Apr;20(4):450-8. doi: 10.1634/theoncologist.2014-0229. Epub 2015 Mar 20.
- Healthcare Cost and Utilization Project (HCUP) Statistical Briefs [Internet]. Rockville (MD): Agency for Healthcare Research and Quality (US); 2006 Feb-. Available from http://www.ncbi.nlm.nih.gov/books/NBK52651/
- Mechanisms and Control of Emesis: A Satellite Symposium of the European Neuroscience Association: Proceedings of an International Meeting Held in Marseille (France), 4-7 September 1992. John Libbey Eurotext
- Pourmand A, Mazer-Amirshahi M, Chistov S, Sabha Y, Vukomanovic D, Almulhim M. Emergency department approach to QTc prolongation. Am J Emerg Med. 2017 Dec;35(12):1928-1933. doi: 10.1016/j.ajem.2017.08.044. Epub 2017 Aug 24.
- Franklin BJ, Vakili S, Huckman RS, Hosein S, Falk N, Cheng K, Murray M, Harris S, Morris CA, Goralnick E. The Inpatient Discharge Lounge as a Potential Mechanism to Mitigate Emergency Department Boarding and Crowding. Ann Emerg Med. 2020 Jun;75(6):704-714. doi: 10.1016/j.annemergmed.2019.12.002. Epub 2020 Jan 23.
- Langford P, Chrisp P. Fosaprepitant and aprepitant: an update of the evidence for their place in the prevention of chemotherapy-induced nausea and vomiting. Core Evid. 2010 Oct 21;5:77-90. doi: 10.2147/ce.s6012.
- Yang Y, Yang N, Wu L, Ouyang Q, Fang J, Li J, Liao W, Cai K, Huang J, Li J, Zhang Y, Wang X, Zhang H, Xu N, Zhao Q, Hu X, Li W, Zhong W, Zhong D, Cheng G, Ye S, Zhong M, Wang D, Liu H, Zheng J, Liu X, Xu H, Zhang L. Safety and efficacy of aprepitant as mono and combination therapy for the prevention of emetogenic chemotherapy-induced nausea and vomiting: post-marketing surveillance in China. Chin Clin Oncol. 2020 Oct;9(5):68. doi: 10.21037/cco-20-160.
- Tramer MR, Phillips C, Reynolds DJ, McQuay HJ, Moore RA. Cost-effectiveness of ondansetron for postoperative nausea and vomiting. Anaesthesia. 1999 Mar;54(3):226-34. doi: 10.1046/j.1365-2044.1999.00704.x.
- Singh P, Yoon SS, Kuo B. Nausea: a review of pathophysiology and therapeutics. Ther Adv Gastroenterol. 2016 Jan;9(1):98-112. doi: 10.1177/1756283X15618131.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2024年11月13日
初级完成 (估计的)
2027年3月1日
研究完成 (估计的)
2027年3月1日
研究注册日期
首次提交
2024年4月19日
首先提交符合 QC 标准的
2024年4月19日
首次发布 (实际的)
2024年4月24日
研究记录更新
最后更新发布 (实际的)
2026年5月18日
上次提交的符合 QC 标准的更新
2026年5月14日
最后验证
2026年5月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
福沙匹坦 150 毫克的临床试验
-
Fondazione Oncotech招聘中
-
Merck Sharp & Dohme LLC完全的人类免疫缺陷病毒 1 (HIV-1)
-
H. Lee Moffitt Cancer Center and Research InstituteGenentech, Inc.招聘中
-
Hoffmann-La RochePfizer完全的中度至重度溃疡性结肠炎美国, 澳大利亚, 泰国, 波兰, 法国, 日本, 西班牙, 印度, 罗马尼亚, 斯洛伐克, 匈牙利, 南非, 比利时, 保加利亚, 德国, 意大利, 墨西哥, 塞尔维亚, 乌克兰, 英国, 俄罗斯, 土耳其（türkiye）, 哥伦比亚
-
EMD Serono完全的系统性红斑狼疮大韩民国, 菲律宾, 西班牙, 美国, 捷克语, 德国, 英国, 南非, 波兰, 阿根廷, 意大利, 智利, 保加利亚, 日本, 巴西, 墨西哥, 秘鲁, 俄罗斯联邦