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

Primary Purpose

Chronic Constipation

Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Linaclotide 290 micrograms
Linaclotide 145 micrograms
Placebo
Sponsored by
Forest Laboratories
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Chronic Constipation focused on measuring Constipation, Chronic Constipation, Linaclotide

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
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  • Forest Investigative Sites
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  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site
  • Forest Investigative Site 1
  • Forest Investigative Site 2
  • Forest Investigative Site
  • Forest Investigative Site

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

1

2

3

Arm Description

Linaclotide 290 micrograms

Linaclotide 145 micrograms

Matching placebo

Outcomes

Primary Outcome Measures

Complete Spontaneous Bowel Movement (CSBM) Overall Responder
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.

Secondary Outcome Measures

12-week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate
The number of CSBMs per week.
12-Week Spontaneous Bowel Movement (SBM) Frequency Rate
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.
12-Week Stool Consistency
The consistency of each BM was assessed using the 7-point Bristol Stool Form Scale: = separate hard lumps like nuts [difficult to pass] = sausage shaped but lumpy = like a sausage but with cracks on surface = like a sausage or snake, smooth and soft = soft blobs with clear-cut edges [passed easily] = fluffy pieces with ragged edges, a mushy stool = watery, no solid pieces [entirely liquid]
12-Week Severity of Straining
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.
12-Week Abdominal Discomfort
Abdominal discomfort is based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe."
12-Week Bloating
Bloating was based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe".
12-Week Constipation Severity
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".

Full Information

First Posted
October 1, 2008
Last Updated
December 19, 2012
Sponsor
Forest Laboratories
Collaborators
Ironwood Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00765882
Brief Title
Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation
Official Title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks in Patients With Chronic Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
September 2008 (undefined)
Primary Completion Date
July 2009 (Actual)
Study Completion Date
August 2009 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Forest Laboratories
Collaborators
Ironwood Pharmaceuticals, Inc.

4. Oversight

5. Study Description

Brief Summary
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Constipation
Keywords
Constipation, Chronic Constipation, Linaclotide

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
633 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
Linaclotide 290 micrograms
Arm Title
2
Arm Type
Experimental
Arm Description
Linaclotide 145 micrograms
Arm Title
3
Arm Type
Placebo Comparator
Arm Description
Matching placebo
Intervention Type
Drug
Intervention Name(s)
Linaclotide 290 micrograms
Intervention Description
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
Intervention Type
Drug
Intervention Name(s)
Linaclotide 145 micrograms
Intervention Description
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Oral, once daily each morning at least 30 minutes before breakfast for the duration of the study
Primary Outcome Measure Information:
Title
Complete Spontaneous Bowel Movement (CSBM) Overall Responder
Description
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.
Time Frame
Change from Baseline to Week 12
Secondary Outcome Measure Information:
Title
12-week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate
Description
The number of CSBMs per week.
Time Frame
Change from Baseline to Week 12
Title
12-Week Spontaneous Bowel Movement (SBM) Frequency Rate
Description
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.
Time Frame
Change from Baseline to Week 12
Title
12-Week Stool Consistency
Description
The consistency of each BM was assessed using the 7-point Bristol Stool Form Scale: = separate hard lumps like nuts [difficult to pass] = sausage shaped but lumpy = like a sausage but with cracks on surface = like a sausage or snake, smooth and soft = soft blobs with clear-cut edges [passed easily] = fluffy pieces with ragged edges, a mushy stool = watery, no solid pieces [entirely liquid]
Time Frame
Change from Baseline to Week 12
Title
12-Week Severity of Straining
Description
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.
Time Frame
Change from Baseline to Week 12
Title
12-Week Abdominal Discomfort
Description
Abdominal discomfort is based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe."
Time Frame
Change from Baseline to Week 12
Title
12-Week Bloating
Description
Bloating was based on a 5-point scale where a value of l is "none" and a value of 5 is "very severe".
Time Frame
Change from Baseline to Week 12
Title
12-Week Constipation Severity
Description
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".
Time Frame
Change from Baseline to Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul F.C. Eng, PhD
Organizational Affiliation
Forest Laboratories
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35205
Country
United States
Facility Name
Forest Investigative Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35215
Country
United States
Facility Name
Forest Investigative Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Forest Investigative Site
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
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United States
Facility Name
Forest Investigative Site
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
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United States
Facility Name
Forest Investigative Site
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
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United States
Facility Name
Forest Investigative Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
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United States
Facility Name
Forest Investigative Site
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
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United States
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Forest Investigative Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
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United States
Facility Name
Forest Investigative Site
City
Burbank
State/Province
California
ZIP/Postal Code
91505
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United States
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Forest Investigative Site
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
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United States
Facility Name
Forest Investigative Site
City
Foothill Ranch
State/Province
California
ZIP/Postal Code
92610
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United States
Facility Name
Forest Investigative Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
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United States
Facility Name
Forest Investigative Site
City
Orange
State/Province
California
ZIP/Postal Code
92869
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United States
Facility Name
Forest Investigative Site
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Westlake Village
State/Province
California
ZIP/Postal Code
91361
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United States
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Forest Investigative Site
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Boulder
State/Province
Colorado
ZIP/Postal Code
80304
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United States
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Forest Investigative Site
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Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80909
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United States
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Denver
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Colorado
ZIP/Postal Code
80205
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United States
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Forest Investigative Site
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Longmont
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Colorado
ZIP/Postal Code
80501
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United States
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Forest Investigative Site
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Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
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United States
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Forest Investigative Site
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Waterbury
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Connecticut
ZIP/Postal Code
06708
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United States
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Forest Investigative Site
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Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
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United States
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Forest Investigative Site
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Bradenton
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Florida
ZIP/Postal Code
34203
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United States
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Forest Investigative Site
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Brooksville
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Florida
ZIP/Postal Code
34601
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United States
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Forest Investigative Site
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Ft. Myers
State/Province
Florida
ZIP/Postal Code
33916
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United States
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Forest Investigative Site
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Jupiter
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Florida
ZIP/Postal Code
33458
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United States
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Forest Investigative Site
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Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
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United States
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Forest Investigative Site
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Miami
State/Province
Florida
ZIP/Postal Code
33143
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United States
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Forest Investigative Site
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Ocala
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Florida
ZIP/Postal Code
34471
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United States
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Forest Investigative Site
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Orlando
State/Province
Florida
ZIP/Postal Code
32806
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United States
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Forest Investigative Site
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Panama City
State/Province
Florida
ZIP/Postal Code
32405
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United States
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Forest Investigative Site
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Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
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United States
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Forest Investigative Site
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St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
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United States
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Forest Investigative Site
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Tampa
State/Province
Florida
ZIP/Postal Code
33606
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United States
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Forest Investigative Site
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Trinity
State/Province
Florida
ZIP/Postal Code
34655
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United States
Facility Name
Forest Investigative Site
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
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United States
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Forest Investigative Site
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Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
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United States
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Forest Investigative Site
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Marietta
State/Province
Georgia
ZIP/Postal Code
30060
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United States
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Forest Investigative Site
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Marietta
State/Province
Georgia
ZIP/Postal Code
30067
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United States
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Forest Investigative Site
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Stockbridge
State/Province
Georgia
ZIP/Postal Code
30281
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United States
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Forest Investigative Site
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Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
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United States
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Forest Investigative Site
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Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
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United States
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Rockford
State/Province
Illinois
ZIP/Postal Code
61107
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United States
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Elkhart
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Indiana
ZIP/Postal Code
46514
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United States
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Forest Investigative Site
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Evansville
State/Province
Indiana
ZIP/Postal Code
47714
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United States
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Forest Investigative Site
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Indianapolis
State/Province
Indiana
ZIP/Postal Code
46237
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United States
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Forest Investigative Site
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Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
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United States
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Forest Investigative Site
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Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
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United States
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Forest Investigative Site
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Arkansas City
State/Province
Kansas
ZIP/Postal Code
67005
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United States
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Forest Investigative Site
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Newton
State/Province
Kansas
ZIP/Postal Code
67114
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United States
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Forest Investigative Site
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Wichita
State/Province
Kansas
ZIP/Postal Code
67205
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United States
Facility Name
Forest Investigative Site
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
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United States
Facility Name
Forest Investigative Site
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Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
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United States
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Forest Investigative Site
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Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
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United States
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Forest Investigative Site
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Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
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United States
Facility Name
Forest Investigative Site
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Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
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United States
Facility Name
Forest Investigative Site
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Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
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United States
Facility Name
Forest Investigative Site
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Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
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United States
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Forest Investigative Site
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Chaska
State/Province
Minnesota
ZIP/Postal Code
55318
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United States
Facility Name
Forest Investigative Site
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St. Louis
State/Province
Missouri
ZIP/Postal Code
63110
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United States
Facility Name
Forest Investigative Site
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St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
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United States
Facility Name
Forest Investigative Site
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Vineland
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New Jersey
ZIP/Postal Code
08360
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United States
Facility Name
Forest Investigative Site
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Albuquerque
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New Mexico
ZIP/Postal Code
87106
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United States
Facility Name
Forest Investigative Site
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Brooklyn
State/Province
New York
ZIP/Postal Code
11214
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United States
Facility Name
Forest Investigative Site
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Great Neck
State/Province
New York
ZIP/Postal Code
11021
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United States
Facility Name
Forest Investigative Site
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Great Neck
State/Province
New York
ZIP/Postal Code
11023
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United States
Facility Name
Forest Investigative Site
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Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
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United States
Facility Name
Forest Investigative Site
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Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
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United States
Facility Name
Forest Investigative Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
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United States
Facility Name
Forest Investigative Site
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
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United States
Facility Name
Forest Investigative Site
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Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
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United States
Facility Name
Forest Investigative Site
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Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
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United States
Facility Name
Forest Investigative Site
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Bismark
State/Province
North Dakota
ZIP/Postal Code
58501
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United States
Facility Name
Forest Investigative Site
City
Akron
State/Province
Ohio
ZIP/Postal Code
44302
Country
United States
Facility Name
Forest Investigative Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
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United States
Facility Name
Forest Investigative Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Forest Investigative Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
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United States
Facility Name
Forest Investigative Site
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Forest Investigative Site
City
Bensalem
State/Province
Pennsylvania
ZIP/Postal Code
19020
Country
United States
Facility Name
Forest Investigative Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
Forest Investigative Site
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Forest Investigative Site
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Forest Investigative Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Forest Investigative Site
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Forest Investigative Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Forest Investigative Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Forest Investigative Site
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
Forest Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Forest Investigative Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Forest Investigative Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Forest Investigative Site
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Forest Investigative Site
City
Christianburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
Facility Name
Forest Investigative Site
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Forest Investigative Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Forest Investigative Site
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Forest Investigative Site
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Forest Investigative Site
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98402
Country
United States
Facility Name
Forest Investigative Site
City
Lakewood
State/Province
Washington
ZIP/Postal Code
98499
Country
United States
Facility Name
Forest Investigative Site
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Forest Investigative Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
Forest Investigative Site
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V67 2K5
Country
Canada
Facility Name
Forest Investigative Site
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Forest Investigative Site
City
Newmarket
State/Province
Ontario
ZIP/Postal Code
L3Y 7V1
Country
Canada
Facility Name
Forest Investigative Site
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2c 3R2
Country
Canada
Facility Name
Forest Investigative Site 1
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Forest Investigative Site 2
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Forest Investigative Site
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 1H5
Country
Canada
Facility Name
Forest Investigative Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
MCN 2V7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
25312449
Citation
Chang L, Lembo AJ, Lavins BJ, Shiff SJ, Hao X, Chickering JG, Jia XD, Currie MG, Kurtz CB, Johnston JM. The impact of abdominal pain on global measures in patients with chronic idiopathic constipation, before and after treatment with linaclotide: a pooled analysis of two randomised, double-blind, placebo-controlled, phase 3 trials. Aliment Pharmacol Ther. 2014 Dec;40(11-12):1302-12. doi: 10.1111/apt.12985. Epub 2014 Oct 13.
Results Reference
derived
PubMed Identifier
21830967
Citation
Lembo AJ, Schneier HA, Shiff SJ, Kurtz CB, MacDougall JE, Jia XD, Shao JZ, Lavins BJ, Currie MG, Fitch DA, Jeglinski BI, Eng P, Fox SM, Johnston JM. Two randomized trials of linaclotide for chronic constipation. N Engl J Med. 2011 Aug 11;365(6):527-36. doi: 10.1056/NEJMoa1010863.
Results Reference
derived

Learn more about this trial

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

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