注射利多卡因膏剂治疗慢性阴囊内容物疼痛男性精索阻滞的一期研究。

Luke D E Witherspoon, Claudia Kesch, Veronika Schmitt, Graeme Boniface, Colin Lundeen, J Curtis Nickel, Ryan Paterson, Martin Gleave, Ryan Flannigan
{"title":"注射利多卡因膏剂治疗慢性阴囊内容物疼痛男性精索阻滞的一期研究。","authors":"Luke D E Witherspoon,&nbsp;Claudia Kesch,&nbsp;Veronika Schmitt,&nbsp;Graeme Boniface,&nbsp;Colin Lundeen,&nbsp;J Curtis Nickel,&nbsp;Ryan Paterson,&nbsp;Martin Gleave,&nbsp;Ryan Flannigan","doi":"10.5489/cuaj.8222","DOIUrl":null,"url":null,"abstract":"<p><strong>Introduction: </strong>Patients with chronic scrotal content pain (CSCP) lack effective, non-invasive treatment options. We aimed to determine the local and systemic safety, tolerability, pharmacokinetics (PK), and efficacy of a long-lasting local anesthetic in patients with CSCP.</p><p><strong>Methods: </strong>This was a prospective, single-center, open-label, single-arm, phase 1, dose-escalating trial completed between October 2019 and March 2021. Twelve patients ≥19 years old with unilateral scrotal pain lasting ≥3 months reporting an average maximum pain score over seven days of ≥4 on a 0-10 numerical rating scale (NRS) were included. Patients underwent a test spermatic cord block and those reporting a decrease of ≥2 points were included. The investigational drug, ST-01 (sustained-release lidocaine polymer solution), is a long-acting injection of lidocaine around the spermatic cord. Subjects were provided a NRS dairy and recorded their NRS score until day 28. The Chronic Epididymitis Symptom Index (CESI) was completed on days 0, 7, 14, and 28. All patients underwent an examination and assessment for adverse events (AE) on days 0, 1, 7, 14, and 28. Exploratory statistical hypothesis testing was planned for this study due to its investigative nature.</p><p><strong>Results: </strong>There were no serious adverse events (SAEs) reported. All subjects reported at least one treatment-emergent adverse event (TEAE); 83% of related AEs were injection-site reactions consisting of swelling and bruising. NRS was reduced across all cohorts between baseline and end of study.</p><p><strong>Conclusions: </strong>This study provides evidence that the novel ST-01 treatment is safe and well-tolerated.</p>","PeriodicalId":9574,"journal":{"name":"Canadian Urological Association journal = Journal de l'Association des urologues du Canada","volume":"17 7","pages":"E194-E201"},"PeriodicalIF":0.0000,"publicationDate":"2023-07-01","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10382213/pdf/cuaj-7-194.pdf","citationCount":"0","resultStr":"{\"title\":\"A phase 1 study of an injectable lidocaine paste for spermatic cord block in men with chronic scrotal content pain.\",\"authors\":\"Luke D E Witherspoon,&nbsp;Claudia Kesch,&nbsp;Veronika Schmitt,&nbsp;Graeme Boniface,&nbsp;Colin Lundeen,&nbsp;J Curtis Nickel,&nbsp;Ryan Paterson,&nbsp;Martin Gleave,&nbsp;Ryan Flannigan\",\"doi\":\"10.5489/cuaj.8222\",\"DOIUrl\":null,\"url\":null,\"abstract\":\"<p><strong>Introduction: </strong>Patients with chronic scrotal content pain (CSCP) lack effective, non-invasive treatment options. We aimed to determine the local and systemic safety, tolerability, pharmacokinetics (PK), and efficacy of a long-lasting local anesthetic in patients with CSCP.</p><p><strong>Methods: </strong>This was a prospective, single-center, open-label, single-arm, phase 1, dose-escalating trial completed between October 2019 and March 2021. Twelve patients ≥19 years old with unilateral scrotal pain lasting ≥3 months reporting an average maximum pain score over seven days of ≥4 on a 0-10 numerical rating scale (NRS) were included. Patients underwent a test spermatic cord block and those reporting a decrease of ≥2 points were included. The investigational drug, ST-01 (sustained-release lidocaine polymer solution), is a long-acting injection of lidocaine around the spermatic cord. Subjects were provided a NRS dairy and recorded their NRS score until day 28. The Chronic Epididymitis Symptom Index (CESI) was completed on days 0, 7, 14, and 28. All patients underwent an examination and assessment for adverse events (AE) on days 0, 1, 7, 14, and 28. Exploratory statistical hypothesis testing was planned for this study due to its investigative nature.</p><p><strong>Results: </strong>There were no serious adverse events (SAEs) reported. All subjects reported at least one treatment-emergent adverse event (TEAE); 83% of related AEs were injection-site reactions consisting of swelling and bruising. NRS was reduced across all cohorts between baseline and end of study.</p><p><strong>Conclusions: </strong>This study provides evidence that the novel ST-01 treatment is safe and well-tolerated.</p>\",\"PeriodicalId\":9574,\"journal\":{\"name\":\"Canadian Urological Association journal = Journal de l'Association des urologues du Canada\",\"volume\":\"17 7\",\"pages\":\"E194-E201\"},\"PeriodicalIF\":0.0000,\"publicationDate\":\"2023-07-01\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10382213/pdf/cuaj-7-194.pdf\",\"citationCount\":\"0\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"Canadian Urological Association journal = Journal de l'Association des urologues du Canada\",\"FirstCategoryId\":\"1085\",\"ListUrlMain\":\"https://doi.org/10.5489/cuaj.8222\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"\",\"JCRName\":\"\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"Canadian Urological Association journal = Journal de l'Association des urologues du Canada","FirstCategoryId":"1085","ListUrlMain":"https://doi.org/10.5489/cuaj.8222","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"","JCRName":"","Score":null,"Total":0}
引用次数: 0

摘要

慢性阴囊内容物痛(CSCP)患者缺乏有效的、非侵入性的治疗方案。我们的目的是确定CSCP患者的局部和全身安全性、耐受性、药代动力学(PK)和长效局麻药的疗效。方法:这是一项前瞻性、单中心、开放标签、单臂、1期、剂量递增试验,于2019年10月至2021年3月完成。纳入12例年龄≥19岁,单侧阴囊疼痛持续≥3个月的患者,在0-10数值评定量表(NRS)上报告7天内平均最大疼痛评分≥4分。接受精索阻断试验的患者和报告下降≥2分的患者被纳入。研究药物ST-01(缓释利多卡因聚合物溶液)是一种长效利多卡因精索周围注射。给受试者提供NRS日记并记录其NRS评分,直至第28天。慢性附睾炎症状指数(CESI)于第0、7、14、28天完成。所有患者在第0、1、7、14和28天接受不良事件(AE)检查和评估。由于其调查性质,本研究计划进行探索性统计假设检验。结果:无严重不良事件(SAEs)报告。所有受试者报告了至少一个治疗出现的不良事件(TEAE);83%的相关不良反应为注射部位反应,包括肿胀和瘀伤。从基线到研究结束,所有队列的NRS都降低了。结论:本研究提供了新的ST-01治疗安全且耐受性良好的证据。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
A phase 1 study of an injectable lidocaine paste for spermatic cord block in men with chronic scrotal content pain.

Introduction: Patients with chronic scrotal content pain (CSCP) lack effective, non-invasive treatment options. We aimed to determine the local and systemic safety, tolerability, pharmacokinetics (PK), and efficacy of a long-lasting local anesthetic in patients with CSCP.

Methods: This was a prospective, single-center, open-label, single-arm, phase 1, dose-escalating trial completed between October 2019 and March 2021. Twelve patients ≥19 years old with unilateral scrotal pain lasting ≥3 months reporting an average maximum pain score over seven days of ≥4 on a 0-10 numerical rating scale (NRS) were included. Patients underwent a test spermatic cord block and those reporting a decrease of ≥2 points were included. The investigational drug, ST-01 (sustained-release lidocaine polymer solution), is a long-acting injection of lidocaine around the spermatic cord. Subjects were provided a NRS dairy and recorded their NRS score until day 28. The Chronic Epididymitis Symptom Index (CESI) was completed on days 0, 7, 14, and 28. All patients underwent an examination and assessment for adverse events (AE) on days 0, 1, 7, 14, and 28. Exploratory statistical hypothesis testing was planned for this study due to its investigative nature.

Results: There were no serious adverse events (SAEs) reported. All subjects reported at least one treatment-emergent adverse event (TEAE); 83% of related AEs were injection-site reactions consisting of swelling and bruising. NRS was reduced across all cohorts between baseline and end of study.

Conclusions: This study provides evidence that the novel ST-01 treatment is safe and well-tolerated.

求助全文
通过发布文献求助,成功后即可免费获取论文全文。 去求助
来源期刊
自引率
0.00%
发文量
0
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:481959085
Book学术官方微信