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LY3556050 在成人糖尿病周围神经病理性疼痛患者中的研究

2026年7月6日 更新者：Eli Lilly and Company

一项 2 期、随机、双盲、安慰剂对照、剂量范围研究，用于评估 LY3556050 在患有糖尿病周围神经性疼痛的成人参与者中的作用

本研究的主要目的是确定 LY3556050 与安慰剂相比，对糖尿病周围神经病理性疼痛 (DPNP) 参与者的安全性和有效性。 该研究将持续约 24 周，分为 3 个研究期。

研究概览

地位

完全的

条件

干预/治疗

研究类型

介入性

注册 (实际的)

404

阶段

  • 阶段2

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。

学习地点

  • 捷克语
      • Olomouc、捷克语、779 00
        • Agentura Science Pro
    • Hradec Králové Region
      • Broumov、Hradec Králové Region、捷克语、550 01
        • EDUMED - Broumov
    • Praha 1
      • Prague、Praha 1、捷克语、11000
        • Diabet2 s.r.o., diabetologicka a interni ambulance
    • Praha 6
      • Prague、Praha 6、捷克语、160 00
        • Neurologická Ambulance - Forbeli
    • Praha, Hlavní Mešto
      • Prague、Praha, Hlavní Mešto、捷克语、160 00
        • FLEDIP - Na dlouhem lanu
      • Prague、Praha, Hlavní Mešto、捷克语、140 00
        • DiaVize s.r.o.
    • Rychnov Nad Kněžnou
      • European Union、Rychnov Nad Kněžnou、捷克语、516 01
        • Vestra Clinics
  • 日本
      • Fukuoka、日本、819-0168
        • Kunisaki Makoto Clinic
      • Osaka、日本、559-0012
        • Minamiosaka Hospital
      • Shizuoka、日本、422-8006
        • Plumeria DM Clinic
    • Ehime
      • Matsuyama、Ehime、日本、790-0067
        • Matsuyama Shimin Hospital
    • Gunma
      • Maebashi、Gunma、日本、370-3573
        • Kikuchi Naika Clinic
    • Hiroshima
      • Kure、Hiroshima、日本、737-0023
        • Kure Medical Center
    • Hokkaido
      • Asahikawa、Hokkaido、日本、070-8530
        • Japanese Red Cross Asahikawa Hospital
    • Kanagawa
      • Yokohama、Kanagawa、日本、232-0064
        • Yokohama Minoru Clinic
    • Osaka
      • Suita-shi、Osaka、日本、565-0853
        • Medical Corporation Heishinkai OCROM Clinic
    • Saitama
      • Sokashi、Saitama、日本、340-0015
        • Sugiura Internal Medicine Clinic
    • Shizuoka
      • Shizuoka、Shizuoka、日本、424-0855
        • Suruga Clinic
    • Tokyo
      • Ootaku、Tokyo、日本、143-0015
        • Medical Corporation Sato Medical clinic
      • Shinjuku-ku、Tokyo、日本、160-0008
        • Heishinkai Medical Group ToCROM Clinic
  • 波兰
    • Greater Poland Voivodeship
      • Poznan、Greater Poland Voivodeship、波兰、61-853
        • Nzoz Neuro-Kard Ilkowski i Partnerzy SPL
    • Kuyavian-Pomeranian Voivodeship
      • Torun、Kuyavian-Pomeranian Voivodeship、波兰、87-100
        • MICS Centrum Medyczne Toruń
    • Lesser Poland Voivodeship
      • Krakow、Lesser Poland Voivodeship、波兰、31-261
        • Medyczne Centrum Diabetologiczno Endokrynologiczno Metaboliczne DIAB-ENDO-MET
    • Lower Silesian Voivodeship
      • Wroclaw、Lower Silesian Voivodeship、波兰、51-162
        • Centrum Badań Klinicznych Piotr Napora lekarze sp.p.
    • Masovian Voivodeship
      • Warsaw、Masovian Voivodeship、波兰、00-874
        • MICS Centrum Medyczne Warszawa
      • Wyszków、Masovian Voivodeship、波兰、07-200
        • Samodzielny Publiczny Zespol Opieki Zdrowotnej w Wyszkow
    • Podlaskie Voivodeship
      • Biaystok、Podlaskie Voivodeship、波兰、15-351
        • Zdrowie Osteo-Medic
    • Silesian Voivodeship
      • Katowice、Silesian Voivodeship、波兰、40-081
        • Centrum Medyczne Pratia Katowice
      • Katowice、Silesian Voivodeship、波兰、40-648
        • Pro Familia Altera
      • Ruda Śląska、Silesian Voivodeship、波兰、41-709
        • NZOZ Przychodnia Specjalistyczna Andrzej Wittek, Henryk Rudzki
    • Łódź Voivodeship
      • Lodz、Łódź Voivodeship、波兰、90-338
        • Centrum Terapii Wspolczesnej J. M. Jasnorzewska Spolka Komandytowo-Akcyjna
  • 美国
    • Arizona
      • Chandler、Arizona、美国、85225
        • The Institute for Liver Health II dba Arizona Clinical Trials - Mesa
      • Scottsdale、Arizona、美国、85260
        • Headlands Research - Scottsdale
      • Tucson、Arizona、美国、85741
        • Orange Grove Family Practice
    • Arkansas
      • Little Rock、Arkansas、美国、72211
        • Preferred Research Partners
    • California
      • Canoga Park、California、美国、91303
        • Hope Clinical Research, Inc.
      • Northridge、California、美国、91325
        • Valley Clinical Trials, Inc.
      • Sacramento、California、美国、95821
        • Northern California Research - Sacramento
    • Connecticut
      • Hamden、Connecticut、美国、06517
        • CMR of Greater New Haven, LLC
    • Florida
      • Miami、Florida、美国、33165
        • New Horizon Research Center
      • Miami、Florida、美国、33135
        • Suncoast Research Group
    • Illinois
      • Chicago、Illinois、美国、60611
        • Northwestern University
    • Kansas
      • Wichita、Kansas、美国、67205
        • Alliance for Multispecialty Research, LLC
    • Kentucky
      • Lexington、Kentucky、美国、40509
        • Alliance for Multispecialty Research, LLC
    • Louisiana
      • Lake Charles、Louisiana、美国、70601
        • Care Access - Lake Charles
    • Massachusetts
      • Waltham、Massachusetts、美国、02451
        • MedVadis Research Corporation
    • Mississippi
      • Ridgeland、Mississippi、美国、39157
        • SKY Integrative Medical Center/SKYCRNG
    • Missouri
      • City of Saint Peters、Missouri、美国、63303
        • StudyMetrix Research
      • Kansas City、Missouri、美国、64114
        • Alliance for Multispecialty Research, LLC
      • Springfield、Missouri、美国、65807
        • Clinvest Research LLC
    • Nevada
      • Las Vegas、Nevada、美国、89128
        • Las Vegas Medical Research
    • New Jersey
      • East Brunswick、New Jersey、美国、08816
        • UniMed Center
    • New York
      • Port Jefferson Station、New York、美国、11776
        • North Suffolk Neurology
    • North Carolina
      • Hickory、North Carolina、美国、28601
        • Lucas Research - Hickory
      • Morehead City、North Carolina、美国、28557
        • Lucas Research, Inc
    • Oregon
      • Medford、Oregon、美国、97504
        • Velocity Clinical Research, Medford
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19114
        • Tristar Clinical Investigations
      • West Chester、Pennsylvania、美国、19380
        • Suburban Research Associates
    • Tennessee
      • Knoxville、Tennessee、美国、37909
        • New Phase Research and Development
    • Texas
      • Austin、Texas、美国、78731
        • FutureSearch Trials of Neurology
      • Houston、Texas、美国、77040
        • Juno Research
      • Shavano Park、Texas、美国、78231
        • Consano Clinical Research, LLC
    • Utah
      • West Jordan、Utah、美国、84088
        • Velocity Clinical Research, Salt Lake City
    • Washington
      • Bellevue、Washington、美国、98007
        • Northwest Clinical Research Center
      • Renton、Washington、美国、98057
        • Rainier Clinical Research Center
  • 韩国
    • Kyǒnggi-do
      • Sosa-gu、Kyǒnggi-do、韩国、14754
        • Sejong General Hospital
    • Seoul-teukbyeolsi [Seoul]
      • Seoul、Seoul-teukbyeolsi [Seoul]、韩国、06351
        • Samsung Medical Center
      • Seoul、Seoul-teukbyeolsi [Seoul]、韩国、01830
        • Nowon Eulji Medical Center, Eulji University
      • Seoul、Seoul-teukbyeolsi [Seoul]、韩国、05030
        • Konkuk University Medical Center
    • Taejǒn-Kwangyǒkshi
      • Daejeon、Taejǒn-Kwangyǒkshi、韩国、01830
        • Eulji University Hospital

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：

  • 在筛查前至少 6 个月内有 1 型糖尿病 (T1D) 或 2 型糖尿病 (T2D) 病史和当前诊断。
  • 在第 1 天之前至少 90 天，通过稳定的糖尿病治疗方案实现稳定的血糖控制，且筛查时糖化血红蛋白 (HbA1c) ≤ 10。
  • 根据参与者报告或病史，每天有周围神经性疼痛史至少 12 周。
  • 筛查期间视觉模拟评分 (VAS) 疼痛值≥40且<95。
  • 患有对称性下肢糖尿病周围神经病变≥6个月，并通过密歇根神经病变筛查仪B部分评分≥3进行诊断
  • 愿意维持任何正在进行的非药物止痛疗法（例如物理疗法）的一致治疗方案，并且在研究参与期间不会开始任何新的非药物止痛疗法。

  • 在研究期间，愿意停止服用所有治疗慢性疼痛的药物，但方案允许的伴随止痛药除外

    • 体重指数≤45公斤/平方米（kg/m²）（含）。
    • 男性或女性是否能够遵守生殖和避孕要求。

排除标准：

  • 其他潜在致病和/或混杂疼痛来源的病史，可能会影响 DPNP 引起的疼痛的自我评估。
  • 在过去 6 个月内进行过旨在使感兴趣的目标区域产生永久性感觉丧失的手术（例如消融技术）。
  • 基线 2 年内患有癌症，通过切除解决的皮肤基底细胞癌或鳞状细胞癌除外。
  • 根据调查人员的判断，有自杀倾向，因此被认为具有显着的自杀风险。
  • 根据研究者的判断，患有急性、严重或不稳定的医疗状况，或者有任何其他医疗疾病的病史或存在，从而妨碍参与研究。
  • 筛查时 HIV 检测结果呈阳性。
  • 在研究期间因任何原因计划进行手术。
  • 患有《精神疾病诊断与统计手册》（第五版；DSM-5；美国精神病学协会）定义的物质使用障碍

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：双倍的

武器和干预

参与者组/臂
干预/治疗
安慰剂比较：Placebo
Participants received a matching dose of placebo administered orally twice daily (BID) over a period of 12 weeks.
药品：安慰剂
口服给药。
实验性的：Mazisotine 50 mg
Participants received mazisotine 50 milligrams (mg) administered orally BID over a period of 12 weeks.
药品：Mazisotine
Administered orally.
其他名称：
  • LY3556050
实验性的：Mazisotine 200 mg
Participants received mazisotine BID orally, starting at 50 mg and titrated weekly, reaching 100 mg BID by Week 2 and a target maintenance dose of 200 mg BID by Week 3, which was then maintained up to Week 12.
药品：Mazisotine
Administered orally.
其他名称：
  • LY3556050
实验性的：Mazisotine 400 mg
Participants received mazisotine BID orally, starting at 50 mg and titrated weekly, reaching 100 mg BID by Week 2, 200 mg BID by Week 3, and 300 mg BID by Week 4, until reaching a target maintenance dose of 400 mg BID by Week 5, which was then maintained up to Week 12.
药品：Mazisotine
Administered orally.
其他名称：
  • LY3556050

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
Mean Change From Baseline in Average Pain Intensity (API) as Measured by Weekly Average of Numeric Rating Scale (NRS) - Bayesian Model Averaging (BMA) Dose-response Model
大体时间：Baseline, Week 12
  • The NRS was a single-item numeric scale used to describe pain severity. Participants were asked to rate their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine; a higher score indicates worse outcome (greater pain severity).
  • The mixed-model repeated measures (MMRM) model included the fixed, centered, categorical effects of region, baseline NRS average pain score, as well as concurrent use of allowed concomitant medications (yes vs. no based on interactive web response system [IWRS]), and visit. The adjusted dose response value from the MMRM was used for fitting a Bayesian model averaging (BMA) dose-response model.
  • Posterior mean change from baseline, 95 percent (%) credible interval was derived using Bayesian mixed model repeated measures. Data presented were posterior mean with 95% credible interval.
Baseline, Week 12
Mean Change From Baseline in Average Pain Intensity (API) as Measured by Weekly Average of Numeric Rating Scale (NRS) - Frequentist Repeated Measures (FRM) Analysis
大体时间：Baseline, Week 12
  • The NRS was a single-item numeric scale used to describe pain severity. Participants were asked to rate their average pain over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine; a higher score indicates worse outcome (greater pain severity).
  • The Least Squares (LS) Mean was calculated using a frequentist repeated measures (FRM) analysis, where Change = treatment, time interval, treatment * time interval, region, average baseline pain severity category (mild or moderate versus [vs.] severe), concurrent use of allowed concomitant medication as entered in IWRS (yes versus no).
Baseline, Week 12

次要结果测量

结果测量
措施说明
大体时间
Mean Change From Baseline in Worst Pain Intensity (WPI) as Measured by Weekly Average of Numeric Rating Scale (NRS)
大体时间：Baseline, Week 12
  • The NRS was a single-item numeric scale used to describe pain severity. Participants were asked to rate their worst pain intensity over the past 24 hours, on a scale of 0 to 10: 0 = no pain, and 10 = pain as bad as you can imagine; a higher score indicates worse outcome (greater pain severity).
  • The LS Mean was calculated using an FRM analysis, where Change = treatment, time interval, treatment * time interval, region, average baseline pain severity category (mild or moderate versus severe), concurrent use of allowed concomitant medication (yes versus no based on IWRS).
Baseline, Week 12
Mean Change From Baseline in Patient-Reported Outcomes Measurement Information System Pain Interference Short Form 8a (PROMIS PI SF8a)
大体时间：Baseline, Week 12
The Patient-Reported Outcomes Measurement Information System Pain Interference Short Form 8a (PROMIS PI SF8a) was administered to measure self-reported consequences of pain on various aspects of the participant's life within the previous 7 days. The scale consists of 8 items, all measuring a single domain of pain interference, including impact on day-to-day activities, work around the home, household chores, family life, social activities, activities done for fun, enjoyment of social activities, and enjoyment of life. Each item was rated on a 5-point response scale ranging from "not at all" (1) to "very much" (5); the 8 item scores were summed to produce a raw score ranging from 8 (minimum) to 40 (maximum). The raw score was then converted to a T-score with a mean of 50 and a standard deviation of 10; higher T-scores indicate worse outcome (greater pain interference). Range cannot be specified in norm-based scores.
Baseline, Week 12
Mean Change From Baseline in Pain Interference With Sleep
大体时间：Baseline, Week 12
  • Pain Interference with Sleep was assessed using a single-item measure: "To what extent did diabetic nerve pain interfere with your sleep last night?" Participants responded on a scale from 0 (minimum, "Not at all") to 4 (maximum, "Unable to sleep at all"); higher scores indicate worse outcome (greater sleep interference due to pain).
  • LS Mean was calculated using an FRM analysis, where Change = treatment, time interval, treatment * time interval, region, average baseline pain severity category (mild or moderate vs. severe), concurrent use of concomitant medication (yes vs. no based on IWRS).
Baseline, Week 12
Mean Change From Baseline in Patient-Reported Outcomes Measurement Information System Physical Functioning Short Form 10a (PROMIS PF SF10a)
大体时间：Baseline, Week 12
The PROMIS PF SF10a was administered to assess self-reported physical function and physical activities across 10 items at the present time.The first 5 items assess current physical limitations (health in doing vigorous activities, walking more than one mile, climbing stairs, lifting or carrying groceries, and bending, kneeling, or stooping), each rated on a 5-point Likert scale ranging from "not at all" to "cannot do". The remaining 5 items are self-reported ability to perform specific physical activities such as chores,dressing themselves, bathing,sitting on and getting up from the toilet, each rated on a 5-point likert scale ranging from "without any difficulty" to "unable to do". The 10 item scores were summed to produce a raw score ranging from 10 (minimum) to 50 (maximum).The raw score was then converted to a T-score with a mean of 50 and a standard deviation of 10; higher T-scores indicate better outcome (greater physical function).Range cannot be specified in norm-based scores.
Baseline, Week 12
Mean Change From Baseline in Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF8b)
大体时间：Baseline, Week 12
The Patient-Reported Outcomes Measurement Information System Sleep Disturbance Short Form 8b (PROMIS SD SF8b) was administered to assess perceptions of sleep quality, sleep depth, and restoration associated with sleep within the previous 7 days, including perceived difficulties and concerns with getting to sleep or staying asleep, and perceptions of the adequacy of and satisfaction with sleep. The scale consists of 8 items, all measuring a single domain of sleep disturbance. Each item was rated on a 5-point response scale ranging from "not at all" to "very much," "never" to "always," or "very poor" to "very good"; the 8 item scores were summed to produce a raw score ranging from 8 (minimum) to 40 (maximum). The raw score was then converted to a T-score with a mean of 50 and a standard deviation of 10; higher T-scores indicate worse outcome (greater sleep disturbance). Range cannot be specified in norm-based scores.
Baseline, Week 12
Mean Change From Baseline in Patient's Global Impression of Illness Severity as Measured by Patient's Global Impression-Severity (PGI-Severity)
大体时间：Baseline, Week 12
  • The Patient's Global Impression-Severity (PGI-Severity) is a patient-reported single-item instrument designed to assess the participant's severity of diabetic nerve pain over the past week. The single item is rated on a 5-point Likert scale ranging from 1 (minimum, "very severe") to 5 (maximum, "none"); higher scores indicate better outcome (less pain severity).
  • The LS Mean was calculated using an FRM analysis, where Change = treatment, time interval, treatment * time interval, region, average baseline pain severity category (mild or moderate vs. severe), concurrent use of allowed concomitant medication (yes vs. no based on IWRS).
Baseline, Week 12
Mean Change From Baseline in Patient's Global Impression (PGI) of Illness Status as Measured by PGI-Status
大体时间：Baseline, Week 12
The Patient's Global Impression-Status (PGI-Status) is a patient-reported single-item instrument designed to assess the participant's status with diabetic nerve pain. Three PGI-Status scales were administered to assess physical activity, usual activity, and sleep disturbance. For physical activity, participants rated their status at the present time; for usual activity and sleep disturbance, participants rated their overall status over the past week. Physical activity and usual activity were each rated on a 5-point Likert scale ranging from 1 (minimum, "extremely limited") to 5 (maximum, "not at all limited"); higher scores indicate better outcome (less limitation). Sleep disturbance was rated on a 5-point Likert scale ranging from 1 (minimum, "very much") to 5 (maximum, "not at all"); higher scores indicate better outcome (less sleep disturbance).
Baseline, Week 12
Patient's Global Impression of Change as Measured by Patient's Global Impression-Change (PGI-Change)
大体时间：Week 12
The Patient's Global Impression-Change (PGI-Change) is a patient-reported single-item instrument designed to assess the participant's rating of change in diabetic nerve pain since they began taking the study medication. Four PGI-Change scales were administered to assess diabetic nerve pain's impact on physical activities, usual activities, sleep disturbance, and overall change. Each item was rated on a 5-point Likert scale ranging from 1 (minimum, "much worse") to 5 (maximum, "much better"); higher scores indicate better outcome (greater improvement).
Week 12
Mean Change From Baseline in Neuropathy Total Symptom Score-6 (NTSS-6)
大体时间：Baseline, Week 12
The NTSS-6 assessed the frequency and intensity of 6 diabetic peripheral neuropathic symptoms over the previous 7 days: (1) numbness and/or insensitivity, (2) prickling and/or tingling sensation, (3) burning sensation, (4) aching pain and/or tightness, (5) sharp, shooting, lancinating pain, and (6) allodynia and/or hyperalgesia. Each of the 6 symptoms was rated on two separate response scales: an intensity scale (Does not apply [0], Mild [1], Moderate [2], or Severe [3]) and a frequency scale (Never [0], Occasionally, less than 1/3 of the time [0], Often, 1/3 to 2/3 of the time [0.33], or Almost always, more than 2/3 of the time [0.66]). The total score was calculated as the weighted sum across all 6 symptoms, where intensity was given a weight of 1 and frequency was given a weight of 1/3, yielding a total score ranging from 0 (minimum, no symptoms) to 21.96 (maximum, most severe); higher scores indicate worse outcome (greater neuropathic symptom burden).
Baseline, Week 12
Total Amount of Rescue Medication Use as Measured by Average Daily Dosage
大体时间：Week 12
Acetaminophen was used as rescue medication during the treatment period. The total amount of rescue medication use was summarized as the average daily dosage at Week 12.
Week 12
Percentage of Participants With at Least One Use of Rescue Medication
大体时间：Week 12
Acetaminophen was used as rescue medication during the treatment period. The percentage of participants with at least one use of rescue medication at Week 12 was reported.
Week 12
Pharmacokinetics (PK): Plasma Concentration of Mazisotine
大体时间：Postdose at Week 12
Mazisotine plasma concentration was reported. The Measure Type was Median and the Measure of Dispersion/Precision was Inter-Quartile Range, where the lower and upper limits represented the 5th and 95th percentiles, respectively.
Postdose at Week 12

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。

赞助

Eli Lilly and Company

调查人员

  • 研究主任：Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST)、Eli Lilly and Company

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。

有用的网址

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)

2023年10月5日

初级完成 (实际的)

2025年6月11日

研究完成 (实际的)

2025年6月11日

研究注册日期

首次提交

2023年10月3日

首先提交符合 QC 标准的

2023年10月3日

首次发布 (实际的)

2023年10月10日

研究记录更新

最后更新发布 (实际的)

2026年7月30日

上次提交的符合 QC 标准的更新

2026年7月6日

最后验证

2026年7月1日

更多信息

与本研究相关的术语

其他相关的 MeSH 术语

其他研究编号

  • 18509
  • J2P-MC-LXBD (其他标识符：Eli Lilly and Company)
  • 2023-506127-29-00 (其他标识符：EU Trial Number)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)？

是的

IPD 计划说明

研究提案获得批准并签署数据共享协议后，将在安全访问环境中提供匿名的个人患者级别数据。

IPD 共享时间框架

数据在美国和欧盟 (EU) 研究的适应症首次发表和批准后 6 个月提供，以较晚者为准。 数据将无限期地可供请求。

IPD 共享访问标准

研究提案必须得到独立审查小组的批准，研究人员必须签署数据共享协议。

IPD 共享支持信息类型

  • 研究方案
  • 树液
  • 企业社会责任

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

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.

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