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Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation

2012年12月19日 更新者：Forest Laboratories

A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks in Patients With Chronic Constipation

The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with chronic constipation (CC). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Complete Spontaneous Bowel Movement (CSBM) Overall Responder

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)

633

阶段

  • 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。

学习地点

  • 加拿大
    • British Columbia
      • Vancouver、British Columbia、加拿大、V67 2K5
        • Forest Investigative Site
    • Ontario
      • Hamilton、Ontario、加拿大、L8N 4A6
        • Forest Investigative Site
      • Newmarket、Ontario、加拿大、L3Y 7V1
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      • Ottawa、Ontario、加拿大、K2c 3R2
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      • Sarnia、Ontario、加拿大、N7T 4X3
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      • Sarnia、Ontario、加拿大、N7T 4X3
        • Forest Investigative Site 2
      • Sudbury、Ontario、加拿大、P3E 1H5
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      • Toronto、Ontario、加拿大、MCN 2V7
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  • 美国
    • Alabama
      • Birmingham、Alabama、美国、35205
        • Forest Investigative Site
      • Birmingham、Alabama、美国、35215
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      • Huntsville、Alabama、美国、35801
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    • Arizona
      • Chandler、Arizona、美国、85225
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      • Mesa、Arizona、美国、85210
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      • Peoria、Arizona、美国、85381
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      • Phoenix、Arizona、美国、85012
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      • Scottsdale、Arizona、美国、85251
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      • Tucson、Arizona、美国、85741
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    • California
      • Burbank、California、美国、91505
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      • Encinitas、California、美国、92024
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      • Foothill Ranch、California、美国、92610
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      • Los Angeles、California、美国、90036
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      • Orange、California、美国、92869
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      • Westlake Village、California、美国、91361
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    • Colorado
      • Boulder、Colorado、美国、80304
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      • Colorado Springs、Colorado、美国、80909
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      • Denver、Colorado、美国、80205
        • Forest Investigative Sites
      • Longmont、Colorado、美国、80501
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      • Wheat Ridge、Colorado、美国、80033
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    • Connecticut
      • Waterbury、Connecticut、美国、06708
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    • Florida
      • Boca Raton、Florida、美国、33486
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      • Bradenton、Florida、美国、34203
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      • Brooksville、Florida、美国、34601
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      • Ft. Myers、Florida、美国、33916
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      • Jupiter、Florida、美国、33458
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      • Kissimmee、Florida、美国、34741
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      • Miami、Florida、美国、33143
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      • Ocala、Florida、美国、34471
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      • Orlando、Florida、美国、32806
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      • Panama City、Florida、美国、32405
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      • Pembroke Pines、Florida、美国、33024
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      • St. Petersburg、Florida、美国、33709
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      • Tampa、Florida、美国、33606
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      • Trinity、Florida、美国、34655
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      • Zephyrhills、Florida、美国、33542
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    • Georgia
      • Atlanta、Georgia、美国、30342
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      • Marietta、Georgia、美国、30060
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      • Marietta、Georgia、美国、30067
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      • Stockbridge、Georgia、美国、30281
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      • Woodstock、Georgia、美国、30189
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    • Idaho
      • Idaho Falls、Idaho、美国、83404
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    • Illinois
      • Rockford、Illinois、美国、61107
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    • Indiana
      • Elkhart、Indiana、美国、46514
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      • Evansville、Indiana、美国、47714
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      • Indianapolis、Indiana、美国、46237
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      • Indianapolis、Indiana、美国、46254
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    • Iowa
      • Iowa City、Iowa、美国、52242
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    • Kansas
      • Arkansas City、Kansas、美国、67005
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      • Newton、Kansas、美国、67114
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      • Wichita、Kansas、美国、67205
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      • Wichita、Kansas、美国、67207
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    • Kentucky
      • Lexington、Kentucky、美国、40509
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      • Madisonville、Kentucky、美国、42431
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    • Maryland
      • Chevy Chase、Maryland、美国、20815
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      • Hagerstown、Maryland、美国、21742
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      • Lutherville、Maryland、美国、21093
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    • Massachusetts
      • Boston、Massachusetts、美国、02135
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    • Minnesota
      • Chaska、Minnesota、美国、55318
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    • Missouri
      • St. Louis、Missouri、美国、63110
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      • St. Louis、Missouri、美国、63128
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    • New Jersey
      • Vineland、New Jersey、美国、08360
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    • New Mexico
      • Albuquerque、New Mexico、美国、87106
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    • New York
      • Brooklyn、New York、美国、11214
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      • Great Neck、New York、美国、11021
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      • Great Neck、New York、美国、11023
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    • North Carolina
      • Fayetteville、North Carolina、美国、28304
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      • Greensboro、North Carolina、美国、27403
        • Forest Investigative Site
      • Hickory、North Carolina、美国、28601
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      • Raleigh、North Carolina、美国、27612
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      • Wilmington、North Carolina、美国、28401
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      • Winston-Salem、North Carolina、美国、27103
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    • North Dakota
      • Bismark、North Dakota、美国、58501
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    • Ohio
      • Akron、Ohio、美国、44302
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      • Cincinnati、Ohio、美国、45219
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      • Cleveland、Ohio、美国、44122
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    • Oklahoma
      • Oklahoma City、Oklahoma、美国、73104
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      • Tulsa、Oklahoma、美国、74135
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    • Pennsylvania
      • Bensalem、Pennsylvania、美国、19020
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      • Pittsburgh、Pennsylvania、美国、15206
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    • South Carolina
      • Greenville、South Carolina、美国、29615
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      • Greer、South Carolina、美国、29651
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    • Tennessee
      • Nashville、Tennessee、美国、37205
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    • Texas
      • Austin、Texas、美国、78705
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      • Dallas、Texas、美国、75234
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      • Houston、Texas、美国、77090
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      • Lake Jackson、Texas、美国、77566
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      • San Antonio、Texas、美国、78229
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      • San Antonio、Texas、美国、78209
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    • Utah
      • Salt Lake City、Utah、美国、84102
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    • Virginia
      • Charlottesville、Virginia、美国、22911
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      • Christianburg、Virginia、美国、24073
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      • Newport News、Virginia、美国、23606
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      • Norfolk、Virginia、美国、23502
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      • Norfolk、Virginia、美国、23507
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      • Richmond、Virginia、美国、23294
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    • Washington
      • Bellevue、Washington、美国、98402
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      • Lakewood、Washington、美国、98499
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      • Wenatchee、Washington、美国、98801
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    • Wisconsin
      • Milwaukee、Wisconsin、美国、53209
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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 has completed a colonoscopy according to the AGA criteria, with no clinically significant findings
  • Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests
  • Patient meets protocol criteria for CC: reports < 3 bowel movements per week and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during > 25% of BMs
  • Patient demonstrates continued chronic constipation through Pretreatment Period
  • Patient is compliant with IVRS

Exclusion Criteria:

  • Patient has history of loose or watery stools
  • Patient has symptoms of or been diagnosed with Irritable Bowel Syndrome (IBS)
  • Patient has a structural abnormality of the gastrointestinal (GI) tract or a disease or condition that can affect GI motility
  • Patient has any protocol-excluded or clinically significant medical or surgical history that could confound the study assessments

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：1
Linaclotide 290 micrograms
药品：利那洛肽 290 微克
在研究期间，每天早上至少在早餐前 30 分钟口服一次
实验性的：2
Linaclotide 145 micrograms
药品：Linaclotide 145 micrograms
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
安慰剂比较：3
Matching placebo
药品：Placebo
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study

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
Complete Spontaneous Bowel Movement (CSBM) Overall Responder
大体时间：Change from Baseline to Week 12

A 12-week CSBM overall responders was defined as a patient who for at least 9 of the 12 weeks of the treatment period had a CSBM weekly frequency rate that was 3 or greater and increased by 1 or more from baseline.

A CSBM was defined as a spontaneous bowel movement (SBM) that was associated with a sense of complete evacuation.

An SBM was defined as a bowel movement (BM) that occurred in the absence of laxative, enema, or suppository use on either the calendar day of the BM or the calendar day before the BM.
Change from Baseline to Week 12

次要结果测量

结果测量
措施说明
大体时间
12-week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate
大体时间：Change from Baseline to Week 12
The number of CSBMs per week.
Change from Baseline to Week 12
12-Week Spontaneous Bowel Movement (SBM) Frequency Rate
大体时间：Change from Baseline to Week 12
A patient's 12-week spontaneous bowel movement (SBM) frequency rate was the number of SBMs per week calculated over the 12-weeks of the treatment period.
Change from Baseline to Week 12
12-Week Stool Consistency
大体时间：Change from Baseline to Week 12

The consistency of each BM was assessed using the 7-point Bristol Stool Form Scale:

  1. = separate hard lumps like nuts [difficult to pass]
  2. = sausage shaped but lumpy
  3. = like a sausage but with cracks on surface
  4. = like a sausage or snake, smooth and soft
  5. = soft blobs with clear-cut edges [passed easily]
  6. = fluffy pieces with ragged edges, a mushy stool
  7. = watery, no solid pieces [entirely liquid]
Change from Baseline to Week 12
12-Week Severity of Straining
大体时间：Change from Baseline to Week 12
Straining is measured on a 5-point scale, where a value of 1 is "not at all" and a value of 5 is "an extreme amount.
Change from Baseline to Week 12
12-Week Abdominal Discomfort
大体时间：Change from Baseline to Week 12
Abdominal discomfort is based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe."
Change from Baseline to Week 12
12-Week Bloating
大体时间：Change from Baseline to Week 12
Bloating was based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe".
Change from Baseline to Week 12
12-Week Constipation Severity
大体时间：Change from Baseline to Week 12
Constipation severity was based on a 5-point ordinal scale where a value of l is "none" and a value of 5 is "very severe".
Change from Baseline to 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

Forest Laboratories

合作者

Ironwood Pharmaceuticals, Inc.

调查人员

  • 研究主任：Paul F.C. Eng, PhD、Forest Laboratories

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

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

2008年9月1日

初级完成 (实际的)

2009年7月1日

研究完成 (实际的)

2009年8月1日

研究注册日期

首次提交

2008年10月1日

首先提交符合 QC 标准的

2008年10月2日

首次发布 (估计)

2008年10月3日

研究记录更新

最后更新发布 (估计)

2013年1月30日

上次提交的符合 QC 标准的更新

2012年12月19日

最后验证

2012年12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

  • LIN-MD-01

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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