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Phase 2a Study of IW-9179 to Treat Functional Dyspepsia

2014年3月18日 更新者：Ironwood Pharmaceuticals, Inc.
The objectives of this study are to determine the safety and efficacy of IW-9179 administered to patients with functional dyspepsia (FD).

研究概览

地位

终止

条件

干预/治疗

研究类型

介入性

注册 (实际的)

10

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

  • 比利时
      • Brugge、比利时、8310
        • AZ Sint-Lucas Brugge
      • Edegem、比利时、2650
        • Antwerp University Hospital
      • Genk、比利时、3600
        • Z.O.L. - Campus St. Jan
      • Gent、比利时、9000
        • Universitair Ziekenhuis Gent
      • Leuven、比利时、3000
        • UZ Leuven
      • Mons、比利时、7000
        • CHU Ambroise Paré
      • Roselare、比利时、8800
        • H. Hartziekenhuis Roselare-Menen vzw
  • 荷兰
      • Almere、荷兰、1311 RL
        • FlevoResearch
      • Beek、荷兰、6191 JW
        • PreCare Trial and Recruitment
      • Breda、荷兰、4811 SW
        • Andromed Breda
      • Eindhoven、荷兰、5616GB
        • Andromed Eindhoven
      • Groningen、荷兰、9711 SG
        • Andromed Noord
      • Leiden、荷兰、2352 RA
        • Andromed Leiden
      • Maastricht、荷兰、6229 HX
        • Maastricht University Med Ctr
      • Rotterdam、荷兰、3021 HC
        • Andromed Rotterdam

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

18年 及以上 (成人、年长者)

接受健康志愿者

不

有资格学习的性别

全部

描述

Inclusion Criteria:

  • Patient meets ROME III criteria for functional dyspepsia (FD)
  • Patient has a normal esophagogastroduodenoscopy (EGD) either during the Screening Period or within 2 years of the Screening Visit

  • Patients who EITHER:

    1. Have not used a proton pump inhibitor (PPI) within 4 weeks of the Screening Visit, OR
    2. Have used a PPI at a stable dose for at least 4 weeks prior to the Screening Visit;
  • Patient meets symptom severity criteria in the Pretreatment Period
  • Patient is fluent and literate in Dutch, French, or English

Exclusion Criteria:

  • Patient meets criteria for gastroesophageal reflux disease (GERD, stable regimen of PPIs acceptable), constipation, diarrhea, lower abdominal pain, or gastroparesis
  • Patient has a history of inflammatory bowel disease, chronic pancreatitis, small intestinal bacterial overgrowth, celiac disease, lactose intolerance, polycystic kidney disease, interstitial cystitis, or scleroderma
  • Any significant neurological disease or a history of cancer (resected basal cell or squamous cell carcinoma of the skin is acceptable; complete remission of other cancers for 5 years or longer is also acceptable)
  • History of active alcoholism or drug addiction within 12 months prior to the Screening Visit
  • Hospitalized for a psychiatric condition or has made a suicide attempt during the two years before the Screening Visit
  • Any organic or structural disease that can cause abdominal pain or discomfort

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：IW-9179
Oral IW-9179 taken daily for two weeks
药品：IW-9179
安慰剂比较：Placebo
Oral placebo taken daily for two weeks
药品：安慰剂

研究衡量的是什么？

主要结果指标

结果测量
大体时间
Rate of treatment-emergent adverse events
大体时间：Reported at any time after the first dose, including the 14 days of treatment and 7 days of follow up
Reported at any time after the first dose, including the 14 days of treatment and 7 days of follow up
Change from baseline 12-lead electrocardiogram (ECG) at day 14 of treatment
大体时间：Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14)
Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14)
Change from baseline clinical laboratory evaluations at the last day of treatment (day 14)
大体时间：Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14)
Baseline values taken just prior to first dose (day 1) compared with values taken on the last day of treatment (day 14)
Change from baseline vital signs at the day 14 visit and at the end of the study (7 days after the last dose)
大体时间：Baseline values taken prior to first dose (day 1) compared with values taken at the day 14 visit (14 days after first dose) and at the end of the study (21 days after the first dose)
Baseline values taken prior to first dose (day 1) compared with values taken at the day 14 visit (14 days after first dose) and at the end of the study (21 days after the first dose)

次要结果测量

结果测量
措施说明
大体时间
Post-meal Symptom Severity (PMSS) Assessment
大体时间：Completed at day 1 and day 14 of the Treatment Period
Assessments completed at 15 min prior to dose, just prior to dose, and every 15 minutes after the first dose through 240 minutes (4 hours after first dose)
Completed at day 1 and day 14 of the Treatment Period
Daily Patient Symptom Severity (PSS) Assessment
大体时间：Average of daily assessments for the 2 weeks just prior to the first dose compared to: 1) the average of the 2 week treatment period, 2) the average of the first week of treatment and 3) the average of the second week of treatment
Assessments recorded on a daily basis
Average of daily assessments for the 2 weeks just prior to the first dose compared to: 1) the average of the 2 week treatment period, 2) the average of the first week of treatment and 3) the average of the second week of treatment
Weekly Symptom Relief (SR) Assessments
大体时间：Average of week 1 and week 2 prior to treatment compared with the week 1 and week 2 during treatment
Assessments recorded on a weekly basis weekly
Average of week 1 and week 2 prior to treatment compared with the week 1 and week 2 during treatment
Nepean Dyspepsia Index
大体时间：Baseline NDI score (collected just prior to first dose) compared with End of Treatment NDI (collected just prior to last dose)
Baseline NDI score (collected just prior to first dose) compared with End of Treatment NDI (collected just prior to last dose)

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

Ironwood Pharmaceuticals, Inc.

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

2012年10月1日

初级完成 (实际的)

2014年2月1日

研究完成 (实际的)

2014年3月1日

研究注册日期

首次提交

2012年10月11日

首先提交符合 QC 标准的

2012年10月19日

首次发布 (估计)

2012年10月23日

研究记录更新

最后更新发布 (估计)

2014年3月19日

上次提交的符合 QC 标准的更新

2014年3月18日

最后验证

2013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

  • ICP-112-201

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