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探索Eluxadoline治疗小儿肠易激综合征腹泻疗效的研究

2026年9月17日 更新者：AbbVie

2 期随机、双盲、安慰剂对照、平行组、剂量范围研究，以评估 Eluxadoline 在伴有腹泻的肠易激综合征 (IBS-D) 儿科参与者（6 至 17 岁）中的安全性和有效性

The primary objectives of this study are to explore the therapeutic effect of eluxadoline in treating irritable bowel syndrome with diarrhea (IBS-D) in pediatric participants 6-17 years of age, to evaluate the pharmacokinetics of eluxadoline in pediatric participants with IBS-D, and to evaluate the safety and tolerability of eluxadoline in pediatric participants with IBS-D. Enrollment of 12-17 years old age group is closed, enrollment of the 6-11 years old age group will continue.

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)

272

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

  • 保加利亚
      • Kozloduy、保加利亚、3320
        • MHATSv.Ivan Rilski /ID# 235399
      • Plovdiv、保加利亚、4001
        • University Hospital Plovdiv /ID# 235450
    • Gabrovo
      • Sevlievo、Gabrovo、保加利亚、5400
        • Medical center 1 Sevlievo /ID# 237473
  • 加拿大
      • Edmonton、加拿大、T6G 1C9
        • Duplicate_Edmonton Clinic Health Academy (ECHA) /ID# 234917
      • Winnepeg、加拿大、R3E 3P4
        • Manitoba Institute of Child Health /ID# 235448
  • 匈牙利
      • Budapest、匈牙利、1125
        • Eszak-Kozep-budai Centrum, Uj Szent Janos Korhaz /ID# 236993
      • Sopron、匈牙利、9400
        • Soproni Erzsebet Oktato Korhaz es Rehabilitacios Intezet /ID# 237341
      • Székesfehérvár、匈牙利、8000
        • Vita Verum Medical Bt. /ID# 234321
  • 德国
      • Wuppertal、德国、42283
        • HELIOS Klinikum Wuppertal /ID# 237322
  • 波兰
    • Lesser Poland Voivodeship
      • Krakow、Lesser Poland Voivodeship、波兰、30-539
        • Specjalistyczne Gabinety Sp. z o.o. /ID# 236347
    • Masovian Voivodeship
      • Warsaw、Masovian Voivodeship、波兰、00-189
        • Centrum Zdrowia MDM /ID# 237269
      • Warsaw、Masovian Voivodeship、波兰、04-730
        • Duplicate_Instytut Pomnik - Centrum Zdrowia Dziecka /ID# 234311
    • Podkarpackie Voivodeship
      • Rzeszów、Podkarpackie Voivodeship、波兰、35-302
        • Korczowski Bartosz Gabinet Lekarski /ID# 234683
    • Pomeranian Voivodeship
      • Gdansk、Pomeranian Voivodeship、波兰、80-803
        • Copertnicus Podmiot Leczniczy Sp. z o.o. /ID# 235656
    • Łódź Voivodeship
      • Lodz、Łódź Voivodeship、波兰、93-338
        • Instytut Centrum Zdrowia Matki Polki /ID# 237438
  • 美国
    • Arkansas
      • Hot Springs、Arkansas、美国、71913
        • HealthStar Research of Hot Springs PLLC /ID# 234609
      • Little Rock、Arkansas、美国、72212-4187
        • Applied Research Center of Arkansas /ID# 238070
    • California
      • Corona、California、美国、92879
        • Kindred Medical Institute, LLC /ID# 237368
      • Garden Grove、California、美国、92845
        • Duplicate_VVCRD Research /ID# 234606
      • Paramount、California、美国、90723
        • Duplicate_Center for Clinical Trials LLC /ID# 234630
    • Florida
      • Miami、Florida、美国、33130
        • Sunrise Research Institute /ID# 237382
      • Miami、Florida、美国、33155
        • South Miami Medical & Research Group Inc. /ID# 234655
      • Miami、Florida、美国、33165
        • Valencia Medical & Research Center /ID# 234672
      • Miami、Florida、美国、33174
        • Florida Research Center, Inc. /ID# 236514
      • Miami Lakes、Florida、美国、33016
        • Duplicate_Wellness Clinical Research /ID# 237401
    • Georgia
      • Atlanta、Georgia、美国、30315
        • Global Research Associates /ID# 234646
      • Atlanta、Georgia、美国、30342
        • Children's Ctr Digestive, US /ID# 237575
      • Stockbridge、Georgia、美国、30281
        • Sleep Care Research Institute d/b/a Clinical Research Institute /ID# 236343
    • Illinois
      • Park Ridge、Illinois、美国、60068
        • Advocate Children's Hospital-Park Ridge /ID# 235388
    • Indiana
      • Indianapolis、Indiana、美国、46202
        • Indiana University Health Riley Hospital for Children /ID# 235400
    • Kentucky
      • Lexington、Kentucky、美国、40517
        • Michael W. Simon, MD, PSC /ID# 236517
    • Maryland
      • New Market、Maryland、美国、21774-6154
        • Frederick County Pediatrics /ID# 234519
    • Minnesota
      • Minneapolis、Minnesota、美国、55413-2195
        • MNGI Digestive Health, P. A. /ID# 238057
    • New Jersey
      • Marlton、New Jersey、美国、08053
        • Celen Medical Group Corp - Marlton /ID# 234922
    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73106
        • IPS Research Company /ID# 237672
    • Pennsylvania
      • Philadelphia、Pennsylvania、美国、19104-4319
        • Children's Hospital of Philadelphia - Main /ID# 234313
      • Pittsburgh、Pennsylvania、美国、15236
        • Preferred Primary Care Physicians, Inc. /ID# 236436
    • Texas
      • Fort Worth、Texas、美国、76104
        • Cook Children's Med. Center /ID# 237537
      • Houston、Texas、美国、77030-2608
        • Texas Children's Hospital /ID# 238304
      • San Antonio、Texas、美国、78215
        • Sun Research Institute /ID# 236933
    • West Virginia
      • Morgantown、West Virginia、美国、26506
        • West Virginia University Hospitals /ID# 256841
  • 英国
      • Blackpool、英国、FY3 8NR
        • Blackpool Teaching Hospitals NHS Foundation Trust /ID# 237273
    • Greater London
      • London、Greater London、英国、SE5 9RS
        • Kings College Hospital NHS Foundation Trust /ID# 236305
    • Lancashire
      • Manchester、Lancashire、英国、M13 9WL
        • Duplicate_Manchester University NHS Foundation Trust /ID# 234663
  • 荷兰
    • North Holland
      • Amsterdam、North Holland、荷兰、1105 AZ
        • Duplicate_Academisch Medisch Centrum /ID# 237117
  • 西班牙
      • Valencia、西班牙、46017
        • Hospital Universitario Dr. Peset /ID# 236755

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

6年 至 17年 (孩子)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Participant must provide written or verbal informed assent and the parent/guardian/LAR must provide written informed consent before the initiation of any study-specific procedures.

  • Participant is a male or female outpatient, 6 to 17 years of age inclusive, at the time the participant provides assent for the study and parent/guardian/LAR has provided signed consent.

  • Participant is able to read and understand the assessments in the eDiary. If the participant is 6 to 11 years of age and does not meet this criterion, the interviewer-administered version of the eDiary must be used and the parent/guardian/LAR or caregiver who will be administering the interviewer-administered version of the eDiary must be able to read and understand the assessments in the eDiary and must undergo training.

  • Female participants must not be pregnant, breastfeeding, or considering becoming pregnant during the study or for approximately 30 days after the last dose of study drug. Female participants of childbearing potential must have a negative serum pregnancy test at Visit 1 (screening) and a negative urine pregnancy test at Visit 3 (randomization) prior to dosing.

  • Female participants of childbearing potential must practice at least 1 protocol-specified method of birth control, that is effective from Study Day 1 through at least 30 days after the last dose of study drug. Local practices may require 2 methods of birth control. Female participants of non-childbearing potential do not need to use birth control.

  • Participant has a diagnosis of IBS-D as defined by the modified Rome IV child/adolescent criteria: Must include all of the following:

    -- Abdominal pain at least 4 days per month over at least 2 months associated with one or more of the following:

    • Related to defecation

    • A change in frequency of stool

    • A change in form (appearance) of stool

      • After appropriate evaluation, the symptoms cannot be fully explained by another medical condition.
      • Participant has predominantly diarrheal stool symptoms defined as Bristol stool types 6 or 7 for more than 25% of bowel movements and Bristol stool types 1 or 2 for less than 25% of bowel movements that occur in the absence of laxative.

    • Participant may be newly diagnosed with IBS-D by the investigator at Visit 1. All criteria for diagnosis must be fulfilled for at least 2 months prior to Visit 1 (screening).

  • Participant has been compliant with the eDiary by completing both the morning and evening assessments for at least 8 out of the 14 days immediately preceding Visit 3 (randomization).

  • Participant has an average daytime abdominal pain score greater than or equal to 1.0 over the 2 weeks prior to randomization.

  • Participant has at least 1 daytime bowel movement with a consistency of Type 6 or Type 7 on the pediatric Bristol Stool Form Scale (p-BSFS) on at least 2 days per week during the 2 weeks immediately prior to randomization and that occurs in the absence of laxatives.

Exclusion Criteria:

  • Participant has no gallbladder, (ie, agenesis of the gallbladder or cholecystectomy).

  • Participant has had any of the following surgeries:

    • Any abdominal surgery within the 3 months prior to Screening; or
    • A history of major gastric, hepatic, pancreatic, or intestinal surgery. (Note: appendectomy, hemorrhoidectomy, or polypectomy greater than 3 months post-surgery are allowed. For the purposes of this study, laparoscopic surgeries without complication are considered minor and non-exclusionary, provided the condition for which the surgery was performed was not exclusionary.)

  • Participant has a history of chronic or severe constipation or sequelae from constipation, or known or suspected mechanical GI obstruction or pseudo obstruction.

  • Participant has a history or current diagnosis of constipation with encopresis.

  • Participant meets the child/adolescent Rome IV criteria of IBS with constipation, IBS with constipation and diarrhea (mixed), unspecified IBS, or functional constipation.

  • Participant has a history of intestinal obstruction, stricture, toxic megacolon, GI perforation, fecal impaction, gastric banding, bariatric surgery, adhesions, ischemic colitis, or impaired intestinal circulation.

  • Participant has a documented history of hepatic impairment as defined by Child-Pugh Classification Grade A, B or C.

  • Participant has a history or current diagnosis of inflammatory or immune-mediated lower GI disorders including inflammatory bowel disease (eg, Crohn's disease, ulcerative colitis, microscopic colitis). Crohn's disease affecting the upper GI tract would also be exclusionary.

  • Participant has celiac disease, or a positive serological test for celiac disease and the condition has not been ruled out by endoscopic biopsy.

  • Participant has any congenital and/or acquired malabsorption syndrome (eg, Shwachman-Diamond syndrome).

  • Participant has a history of a microbiologically documented (ie, stool culture or medical history) GI infection within 3 months prior to Screening.

  • Participant has a known lactose or fructose intolerance that is associated with diarrhea, abdominal pain or discomfort, and that could confound assessments in the study.

  • Participant has a history of diverticulitis within 3 months prior to Screening.

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：三倍

武器和干预

参与者组/臂
干预/治疗
实验性的：Eluxadoline 25mg

Eluxadoline 25mg, oral administration, twice daily
药品：Eluxadoline

Oral tablets

其他名称：
  • 维贝齐
实验性的：Eluxadoline 50mg

Eluxadoline 50mg, oral administration, twice daily
药品：Eluxadoline

Oral tablets

其他名称：
  • 维贝齐
实验性的：Eluxadoline 100mg

Eluxadoline 100mg, oral administration, twice daily
药品：Eluxadoline

Oral tablets

其他名称：
  • 维贝齐
实验性的：Placebo

Dose-matched placebo, oral administration, twice daily
药品：Placebo

Oral tablets

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
Change from baseline in stool consistency averaged over the 4-week Treatment Period
大体时间：Baseline (2 Weeks prior to randomization) to Week 4

Stool consistency will be assessed using the Pediatric Bristol Stool Form Scale (p-BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).
Baseline (2 Weeks prior to randomization) to Week 4

次要结果测量

结果测量
措施说明
大体时间
Change from baseline in stool consistency for daily daytime and nighttime stool consistency scores
大体时间：Baseline (2 Weeks prior to randomization) to Week 4

Stool consistency will be assessed using the Pediatric Bristol Stool Form Scale (p-BSFS) on a range from 1 (Hard Lumps) to 7 (Watery).
Baseline (2 Weeks prior to randomization) to Week 4
Change from baseline for daytime, nighttime, and 24-hour abdominal pain scores
大体时间：Baseline (2 Weeks prior to randomization) to Week 4

Abdominal Pain is scored on a five-point ordinal scale, with 0 meaning no pain, and 4 meaning a lot of pain.
Baseline (2 Weeks prior to randomization) to Week 4
Change from baseline for daytime, nighttime, and 24-hour bowel movement frequency
大体时间：Baseline (2 Weeks prior to randomization) to Week 4

Change from baseline in the number of bowel movements.
Baseline (2 Weeks prior to randomization) to Week 4
Change from baseline for daytime, nighttime, and 24 hour urgency-free days
大体时间：Baseline (2 Weeks prior to randomization) to Week 4

Change from baseline in the number of urgency free days in a week.
Baseline (2 Weeks prior to randomization) to Week 4
Change from baseline for daytime, nighttime, and 24 hour number of fecal incontinence-free days
大体时间：Baseline (2 Weeks prior to randomization) to Week 4

Change from baseline in the number of fecal incontinence-free days in a week.
Baseline (2 Weeks prior to randomization) to Week 4

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

AbbVie

调查人员

  • 研究主任：ABBVIE INC.、AbbVie

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)

2017年11月15日

初级完成 (实际的)

2026年8月17日

研究完成 (实际的)

2026年8月17日

研究注册日期

首次提交

2017年11月8日

首先提交符合 QC 标准的

2017年11月8日

首次发布 (实际的)

2017年11月13日

研究记录更新

最后更新发布 (实际的)

2026年9月21日

上次提交的符合 QC 标准的更新

2026年9月17日

最后验证

2026年9月1日

更多信息

与本研究相关的术语

关键字

其他相关的 MeSH 术语

其他研究编号

  • 3030-202-002
  • 2017 (美国 NIH 拨款/合同)
  • 2017-003770-14 (EudraCT编号)

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

AbbVie is committed to responsible clinical trial data sharing. This includes access to anonymized, individual and trial-level data (analysis data sets), as well as other information.

IPD 共享时间框架

For details on when studies are available for sharing visit https://vivli.org/ourmember/abbvie/

IPD 共享访问标准

To learn more about the process, or to submit a request, visit the following link https://www.abbvieclinicaltrials.com/hcp/data-sharing/

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

在美国制造并从美国出口的产品

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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