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Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation

Primary Purpose

Irritable Bowel Syndrome Characterized by Constipation

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

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome Characterized by Constipation focused on measuring Irritable Bowel Syndrome, Constipation, Linaclotide

Eligibility Criteria

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

Inclusion Criteria:

  • Patient meets protocol criteria for IBS: reports abdominal discomfort or pain that has two or more of the following three features:

    1. Relieved with defecation
    2. Onset associated with a change in frequency of stool
    3. Onset associated with a change in form (appearance) of stool
  • Patient reports < 3 bowel movements (BMs) per week (in the absence of any laxative, suppository, or enema use during the preceding 24 hours) and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during > 25% of BMs
  • Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests (some patients may require a colonoscopy per American Gastroenterological Association (AGA) guidelines)
  • Patient is compliant with Interactive Voice Response System (IVRS) for daily diary reporting of BM habits and IBS symptoms

Exclusion Criteria:

  • Patient has history of loose or watery stools for >25% of BMs
  • Patient has a structural abnormality of the gastrointestinal (GI) tract or a history of a disease or condition that can affect GI motility
  • Patient has any protocol-excluded or clinically significant medical or surgical history or concomitant medication use that could confound the study assessments

Sites / Locations

  • Forest Investigative Site 037
  • Forest Investigative Site 036
  • Forest Investigative Site 135
  • Forest Investigative Site 014
  • Forest Investigative Site 080
  • Forest Investigative Site 053
  • Forest Investigative Site 078
  • Forest Investigative Site 101
  • Forest Investigative Site 128
  • Forest Investigative Site 051
  • Forest Investigative Site 136
  • Forest Investigative Site 087
  • Forest Investigative Site 094
  • Forest Investigative Site 026
  • Forest Investigative Site 096
  • Forest Investigative Site 057
  • Forest Investigative Site 097
  • Forest Investigative Site 005
  • Forest Investigative Site 024
  • Forest Investigative Site 021
  • Forest Investigative Site 019
  • Forest Investigative Site 034
  • Forest Investigative Site 074
  • Forest Investigative Site 010
  • Forest Investigative Site 058
  • Forest Investigative Site 042
  • Forest Investigative Site 003
  • Forest Investigative Site 137
  • Forest Investigative Site 070
  • Forest Investigative Site 018
  • Forest Investigative Site 030
  • Forest Investigative Site 077
  • Forest Investigative Site 133
  • Forest Investigative Site 031
  • Forest Investigative Site 129
  • Forest Investigative Site 108
  • Forest Investigative Site 092
  • Forest Investigative Site 038
  • Forest Investigative Site 027
  • Forest Investigative Site 045
  • Forest Investigative Site 015
  • Forest Investigative Site 104
  • Forest Investigative Site 068
  • Forest Investigative Site 032
  • Forest Investigative Site 103
  • Forest Investigative Site 033
  • Forest Investigative Site 020
  • Forest Investigative Site 040
  • Forest Investigative Site 055
  • Forest Investigative Site 043
  • Forest Investigative Site 047
  • Forest Investigative Site 046
  • Forest Investigative Site 029
  • Forest Investigative Site 009
  • Forest Investigative Site 023
  • Forest Investigative Site 093
  • Forest Investigative Site 067
  • Forest Investigative Site 114
  • Forest Investigative Site 132
  • Forest Investigative Site 124
  • Forest Investigative Site 013
  • Forest Investigative Site 006
  • Forest Investigative Site 073
  • Forest Investigative Site 001
  • Forest Investigative Site 125
  • Forest Investigative Site 064
  • Forest Investigative Site 004
  • Forest Investigative Site 085
  • Forest Investigative Site 052
  • Forest Investigative Site 035
  • Forest Investigative Site 017
  • Forest Investigative Site 011
  • Forest Investigative Site 134
  • Forest Investigative Site 122
  • Forest Investigative Site 072
  • Forest Investigative Site 016
  • Forest Investigative Site 119
  • Forest Investigative Site 088
  • Forest Investigative Site 056
  • Forest Investigative Site 065
  • Forest Investigative Site 028
  • Forest Investigative Site 044
  • Forest Investigative Site 123
  • Forest Investigative Site 130
  • Forest Investigative Site 082
  • Forest Investigative Site 102
  • Forest Investigative Site 039
  • Forest Investigative Site 121
  • Forest Investigative Site 069
  • Forest Investigative Site 131
  • Forest Investigative Site 025
  • Forest Investigative Site 099
  • Forest Investigative Site 002
  • Forest Investigative Site 041
  • Forest Investigative Site 110
  • Forest Investigative Site 063
  • Forest Investigative Site 095
  • Forest Investigative Site 076
  • Forest Investigative Site 089
  • Forest Investigative Site 091
  • Forest Investigative Site 100
  • Forest Investigative Site 054
  • Forest Investigative Site 061
  • Forest Investigative Site 007
  • Forest Investigative Site 060
  • Forest Investigative Site 075
  • Forest Investigative Site 050
  • Forest Investigative Site 049
  • Forest Investigative Site 098
  • Forest Investigative Site 066
  • Forest Investigative Site 083
  • Forest Investigative Site 107
  • Forest Investigative Site 112
  • Forest Investigative Site 106
  • Forest Investigative Site 115
  • Forest Investigative Site 113
  • Forest Investigative Site 008
  • Forest Investigative Site 116

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Linaclotide

Placebo

Arm Description

Linaclotide 290 micrograms

Matching placebo

Outcomes

Primary Outcome Measures

Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks
A patient is considered to be an APC responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs, experienced an increase of at least 1 CSBM from baseline, and experienced a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week. The AP score assesses the worst of a patient's AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP. A CSBM is defined as a spontaneous bowel movement, associated with a sense of complete evacuation.
Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks
A patient is considered to be a CSBM 3+1 responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs and experienced an increase of at least 1 CSBM from baseline during a particular week. 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.
Abdominal Pain Responder, 9 Out of 12 Weeks
A patient is considered to be an abdominal pain responder if, for at least 9 out of the 12 weeks of the treatment period, they experienced a decrease of at least 30 percent in the mean abdominal pain score from baseline during a particular week. The Abdominal Pain score assesses the worst of a patient's abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks.
A patient is considered an APC responder if, for at least 6 of the 12 weeks of the treatment, the patient experienced an increase of at least 1 Complete Spontaneous Bowel Movement (CSBM) from baseline and experienced a decrease of at least 30 percent in their Abdominal Pain (AP)score during a particular week. The AP score assesses the worst of a patient's AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP. A CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation.

Secondary Outcome Measures

12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency Rate
The number of CSBMs per week.
12-Week Spontaneous Bowl Movement (SBM) Frequency Rate
The number of Spontaneous Bowl Movements experienced per week.
12-Week Stool Consistency
The consistency of each BM was assessed by patients using the 7-point Bristol Stool Form Scale (BSFS) from 1 to 7. = 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 Change in Abdominal Pain Score
Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
12-Week Change in Abdominal Discomfort
Abdominal Discomfort is measured on an 11-point scale where a value of 0 is "none" and a value of 10 is "very severe."
12-Week Change in Bloating
Bloating was assessed on an 11-point scale where a value of 0 is "none" and a value of 10 is "very severe".
Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment
A patient is considered to be a CSBM responder if, for at least 6 out of the 12 weeks of the treatment period, an increase of at least 1 CSBM per week from baseline was experienced.
Abdominal Pain Responder for 6 Out of 12 Weeks
A patient is considered to be an abdominal pain responder if, for at least 6 out of the 12 weeks of the treatment period, they experienced a decrease of 30 percent or more in the abdominal pain score from baseline. The Abdominal Pain score assesses the worst of a patient's abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
12-Week Percent of Abdominal Pain-free (APF) Days
Abdominal pain free (APF) days are those days where the patient reported a score of '0' for abdominal pain at its worst Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.

Full Information

First Posted
July 28, 2009
Last Updated
December 19, 2012
Sponsor
Forest Laboratories
Collaborators
Ironwood Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00948818
Brief Title
Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation
Official Title
A Phase III, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Trial of Linaclotide Administered Orally for 12 Weeks Followed by a 4-Week Randomized Withdrawal Period in Patients With Irritable Bowel Syndrome With Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
July 2010 (Actual)
Study Completion Date
August 2010 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objective of this trial is to determine the efficacy and safety of linaclotide administered to patients with irritable bowel syndrome with constipation (IBS-C). The primary efficacy parameter is the percentage of patients in each treatment group that meet the protocol definition for Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome Characterized by Constipation
Keywords
Irritable Bowel Syndrome, Constipation, Linaclotide

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Linaclotide
Arm Type
Experimental
Arm Description
Linaclotide 290 micrograms
Arm Title
Placebo
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)
Matching 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
Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks
Description
A patient is considered to be an APC responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs, experienced an increase of at least 1 CSBM from baseline, and experienced a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week. The AP score assesses the worst of a patient's AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP. A CSBM is defined as a spontaneous bowel movement, associated with a sense of complete evacuation.
Time Frame
Change from Baseline to Week 12
Title
Complete Spontaneous Bowel Movement (CSBM) 3+1 Responder, 9 Out of 12 Weeks
Description
A patient is considered to be a CSBM 3+1 responder if, for at least 9 out of the 12 weeks of the treatment period, the patient had at least 3 CSBMs and experienced an increase of at least 1 CSBM from baseline during a particular week. 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
Title
Abdominal Pain Responder, 9 Out of 12 Weeks
Description
A patient is considered to be an abdominal pain responder if, for at least 9 out of the 12 weeks of the treatment period, they experienced a decrease of at least 30 percent in the mean abdominal pain score from baseline during a particular week. The Abdominal Pain score assesses the worst of a patient's abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
Time Frame
Change from Baseline to Week 12
Title
Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 6 Out of 12 Weeks.
Description
A patient is considered an APC responder if, for at least 6 of the 12 weeks of the treatment, the patient experienced an increase of at least 1 Complete Spontaneous Bowel Movement (CSBM) from baseline and experienced a decrease of at least 30 percent in their Abdominal Pain (AP)score during a particular week. The AP score assesses the worst of a patient's AP in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no AP and 10 represents very severe AP. A CSBM was defined as a Spontaneous Bowel Movement (SBM) that was associated with a sense of complete evacuation.
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 Bowl Movement (SBM) Frequency Rate
Description
The number of Spontaneous Bowl Movements experienced per week.
Time Frame
Change from Baseline to Week 12
Title
12-Week Stool Consistency
Description
The consistency of each BM was assessed by patients using the 7-point Bristol Stool Form Scale (BSFS) from 1 to 7. = 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 Change in Abdominal Pain Score
Description
Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
Time Frame
Change from Baseline to Week 12
Title
12-Week Change in Abdominal Discomfort
Description
Abdominal Discomfort is measured on an 11-point scale where a value of 0 is "none" and a value of 10 is "very severe."
Time Frame
Change from Baseline to Week 12
Title
12-Week Change in Bloating
Description
Bloating was assessed on an 11-point scale where a value of 0 is "none" and a value of 10 is "very severe".
Time Frame
Change from Baseline to Week 12
Title
Complete Spontaneous Bowl Movement (CSBM) Responder for 6 Weeks Out of 12 Weeks of Treatment
Description
A patient is considered to be a CSBM responder if, for at least 6 out of the 12 weeks of the treatment period, an increase of at least 1 CSBM per week from baseline was experienced.
Time Frame
Change from Baseline to Week 12
Title
Abdominal Pain Responder for 6 Out of 12 Weeks
Description
A patient is considered to be an abdominal pain responder if, for at least 6 out of the 12 weeks of the treatment period, they experienced a decrease of 30 percent or more in the abdominal pain score from baseline. The Abdominal Pain score assesses the worst of a patient's abdominal pain in the past 24 hours using an 11-point scale (from 0-10), where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
Time Frame
Change from Baseline to Week 12
Title
12-Week Percent of Abdominal Pain-free (APF) Days
Description
Abdominal pain free (APF) days are those days where the patient reported a score of '0' for abdominal pain at its worst Abdominal Pain at its worst (in the last 24 hours) is based on an 11-point scale where 0 represents no abdominal pain and 10 represents very severe abdominal pain.
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 meets protocol criteria for IBS: reports abdominal discomfort or pain that has two or more of the following three features: Relieved with defecation Onset associated with a change in frequency of stool Onset associated with a change in form (appearance) of stool Patient reports < 3 bowel movements (BMs) per week (in the absence of any laxative, suppository, or enema use during the preceding 24 hours) and reports straining, lumpy or hard stools, and/or sensation of incomplete evacuation during > 25% of BMs Patient has successfully completed protocol procedures (with no clinically significant findings): physical exam, 12-lead ECG, or clinical laboratory tests (some patients may require a colonoscopy per American Gastroenterological Association (AGA) guidelines) Patient is compliant with Interactive Voice Response System (IVRS) for daily diary reporting of BM habits and IBS symptoms Exclusion Criteria: Patient has history of loose or watery stools for >25% of BMs Patient has a structural abnormality of the gastrointestinal (GI) tract or a history of a disease or condition that can affect GI motility Patient has any protocol-excluded or clinically significant medical or surgical history or concomitant medication use that could confound the study assessments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul F.C. Eng, PhD
Organizational Affiliation
Forest Research Institute, a subsidiary of Forest Laboratories Inc.
Official's Role
Study Director
Facility Information:
Facility Name
Forest Investigative Site 037
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Forest Investigative Site 036
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35215
Country
United States
Facility Name
Forest Investigative Site 135
City
Hueytown
State/Province
Alabama
ZIP/Postal Code
35023
Country
United States
Facility Name
Forest Investigative Site 014
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Forest Investigative Site 080
City
Chandler
State/Province
Arizona
ZIP/Postal Code
85225
Country
United States
Facility Name
Forest Investigative Site 053
City
Mesa
State/Province
Arizona
ZIP/Postal Code
85210
Country
United States
Facility Name
Forest Investigative Site 078
City
Peoria
State/Province
Arizona
ZIP/Postal Code
85381
Country
United States
Facility Name
Forest Investigative Site 101
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Forest Investigative Site 128
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85018
Country
United States
Facility Name
Forest Investigative Site 051
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85251
Country
United States
Facility Name
Forest Investigative Site 136
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Forest Investigative Site 087
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Forest Investigative Site 094
City
Burbank
State/Province
California
ZIP/Postal Code
91505
Country
United States
Facility Name
Forest Investigative Site 026
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Forest Investigative Site 096
City
Foothill Ranch
State/Province
California
ZIP/Postal Code
92610
Country
United States
Facility Name
Forest Investigative Site 057
City
Los Angeles
State/Province
California
ZIP/Postal Code
90036
Country
United States
Facility Name
Forest Investigative Site 097
City
Mission Hills
State/Province
California
ZIP/Postal Code
91345
Country
United States
Facility Name
Forest Investigative Site 005
City
Orange
State/Province
California
ZIP/Postal Code
92869
Country
United States
Facility Name
Forest Investigative Site 024
City
Westlake Village
State/Province
California
ZIP/Postal Code
91361
Country
United States
Facility Name
Forest Investigative Site 021
City
Boulder
State/Province
Colorado
ZIP/Postal Code
80304
Country
United States
Facility Name
Forest Investigative Site 019
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80907
Country
United States
Facility Name
Forest Investigative Site 034
City
Denver
State/Province
Colorado
ZIP/Postal Code
80205
Country
United States
Facility Name
Forest Investigative Site 074
City
Longmont
State/Province
Colorado
ZIP/Postal Code
80501
Country
United States
Facility Name
Forest Investigative Site 010
City
Wheat Ridge
State/Province
Colorado
ZIP/Postal Code
80033
Country
United States
Facility Name
Forest Investigative Site 058
City
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Forest Investigative Site 042
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33486
Country
United States
Facility Name
Forest Investigative Site 003
City
Bradenton
State/Province
Florida
ZIP/Postal Code
34203
Country
United States
Facility Name
Forest Investigative Site 137
City
Brandon
State/Province
Florida
ZIP/Postal Code
33511
Country
United States
Facility Name
Forest Investigative Site 070
City
Brooksville
State/Province
Florida
ZIP/Postal Code
34613
Country
United States
Facility Name
Forest Investigative Site 018
City
Ft. Myers
State/Province
Florida
ZIP/Postal Code
33916
Country
United States
Facility Name
Forest Investigative Site 030
City
Jupiter
State/Province
Florida
ZIP/Postal Code
33458
Country
United States
Facility Name
Forest Investigative Site 077
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34741
Country
United States
Facility Name
Forest Investigative Site 133
City
Miami
State/Province
Florida
ZIP/Postal Code
33126
Country
United States
Facility Name
Forest Investigative Site 031
City
Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Forest Investigative Site 129
City
New Smyrna Beach
State/Province
Florida
ZIP/Postal Code
32168
Country
United States
Facility Name
Forest Investigative Site 108
City
Ocala
State/Province
Florida
ZIP/Postal Code
34471
Country
United States
Facility Name
Forest Investigative Site 092
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Forest Investigative Site 038
City
Panama City
State/Province
Florida
ZIP/Postal Code
32405
Country
United States
Facility Name
Forest Investigative Site 027
City
Pembroke Pines
State/Province
Florida
ZIP/Postal Code
33024
Country
United States
Facility Name
Forest Investigative Site 045
City
St. Petersburg
State/Province
Florida
ZIP/Postal Code
33709
Country
United States
Facility Name
Forest Investigative Site 015
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Forest Investigative Site 104
City
Trinity
State/Province
Florida
ZIP/Postal Code
34655
Country
United States
Facility Name
Forest Investigative Site 068
City
Zephyrhills
State/Province
Florida
ZIP/Postal Code
33542
Country
United States
Facility Name
Forest Investigative Site 032
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Forest Investigative Site 103
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30342
Country
United States
Facility Name
Forest Investigative Site 033
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30060
Country
United States
Facility Name
Forest Investigative Site 020
City
Marietta
State/Province
Georgia
ZIP/Postal Code
30067
Country
United States
Facility Name
Forest Investigative Site 040
City
Woodstock
State/Province
Georgia
ZIP/Postal Code
30189
Country
United States
Facility Name
Forest Investigative Site 055
City
Idaho Falls
State/Province
Idaho
ZIP/Postal Code
83404
Country
United States
Facility Name
Forest Investigative Site 043
City
Rockford
State/Province
Illinois
ZIP/Postal Code
61107
Country
United States
Facility Name
Forest Investigative Site 047
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Forest Investigative Site 046
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Forest Investigative Site 029
City
Arkansas City
State/Province
Kansas
ZIP/Postal Code
67005
Country
United States
Facility Name
Forest Investigative Site 009
City
Newton
State/Province
Kansas
ZIP/Postal Code
67114
Country
United States
Facility Name
Forest Investigative Site 023
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67205
Country
United States
Facility Name
Forest Investigative Site 093
City
Wichita
State/Province
Kansas
ZIP/Postal Code
67207
Country
United States
Facility Name
Forest Investigative Site 067
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40509
Country
United States
Facility Name
Forest Investigative Site 114
City
Madisonville
State/Province
Kentucky
ZIP/Postal Code
42431
Country
United States
Facility Name
Forest Investigative Site 132
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70808
Country
United States
Facility Name
Forest Investigative Site 124
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71101
Country
United States
Facility Name
Forest Investigative Site 013
City
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Forest Investigative Site 006
City
Hagerstown
State/Province
Maryland
ZIP/Postal Code
21742
Country
United States
Facility Name
Forest Investigative Site 073
City
Lutherville
State/Province
Maryland
ZIP/Postal Code
21093
Country
United States
Facility Name
Forest Investigative Site 001
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Forest Investigative Site 125
City
Kalamazoo
State/Province
Michigan
ZIP/Postal Code
49048
Country
United States
Facility Name
Forest Investigative Site 064
City
Chaska
State/Province
Minnesota
ZIP/Postal Code
55318
Country
United States
Facility Name
Forest Investigative Site 004
City
St. Louis
State/Province
Missouri
ZIP/Postal Code
63128
Country
United States
Facility Name
Forest Investigative Site 085
City
Vineland
State/Province
New Jersey
ZIP/Postal Code
08360
Country
United States
Facility Name
Forest Investigative Site 052
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Forest Investigative Site 035
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11214
Country
United States
Facility Name
Forest Investigative Site 017
City
Great Neck
State/Province
New York
ZIP/Postal Code
11021
Country
United States
Facility Name
Forest Investigative Site 011
City
Great Neck
State/Province
New York
ZIP/Postal Code
11023
Country
United States
Facility Name
Forest Investigative Site 134
City
Setauket
State/Province
New York
ZIP/Postal Code
11733
Country
United States
Facility Name
Forest Investigative Site 122
City
Boone
State/Province
North Carolina
ZIP/Postal Code
28607
Country
United States
Facility Name
Forest Investigative Site 072
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
Country
United States
Facility Name
Forest Investigative Site 016
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27403
Country
United States
Facility Name
Forest Investigative Site 119
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28601
Country
United States
Facility Name
Forest Investigative Site 088
City
Raleigh
State/Province
North Carolina
ZIP/Postal Code
27612
Country
United States
Facility Name
Forest Investigative Site 056
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
Country
United States
Facility Name
Forest Investigative Site 065
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Forest Investigative Site 028
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Forest Investigative Site 044
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Forest Investigative Site 123
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43215
Country
United States
Facility Name
Forest Investigative Site 130
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45432
Country
United States
Facility Name
Forest Investigative Site 082
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73104
Country
United States
Facility Name
Forest Investigative Site 102
City
Tulsa
State/Province
Oklahoma
ZIP/Postal Code
74135
Country
United States
Facility Name
Forest Investigative Site 039
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
Forest Investigative Site 121
City
Greenville
State/Province
South Carolina
ZIP/Postal Code
29615
Country
United States
Facility Name
Forest Investigative Site 069
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Forest Investigative Site 131
City
Greer
State/Province
South Carolina
ZIP/Postal Code
29651
Country
United States
Facility Name
Forest Investigative Site 025
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37205
Country
United States
Facility Name
Forest Investigative Site 099
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Forest Investigative Site 002
City
Dallas
State/Province
Texas
ZIP/Postal Code
75234
Country
United States
Facility Name
Forest Investigative Site 041
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Forest Investigative Site 110
City
Houston
State/Province
Texas
ZIP/Postal Code
77090
Country
United States
Facility Name
Forest Investigative Site 063
City
Lake Jackson
State/Province
Texas
ZIP/Postal Code
77566
Country
United States
Facility Name
Forest Investigative Site 095
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
Country
United States
Facility Name
Forest Investigative Site 076
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Forest Investigative Site 089
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84102
Country
United States
Facility Name
Forest Investigative Site 091
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84132
Country
United States
Facility Name
Forest Investigative Site 100
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84148
Country
United States
Facility Name
Forest Investigative Site 054
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22911
Country
United States
Facility Name
Forest Investigative Site 061
City
Christianburg
State/Province
Virginia
ZIP/Postal Code
24073
Country
United States
Facility Name
Forest Investigative Site 007
City
Newport News
State/Province
Virginia
ZIP/Postal Code
23606
Country
United States
Facility Name
Forest Investigative Site 060
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23502
Country
United States
Facility Name
Forest Investigative Site 075
City
Norfolk
State/Province
Virginia
ZIP/Postal Code
23507
Country
United States
Facility Name
Forest Investigative Site 050
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23294
Country
United States
Facility Name
Forest Investigative Site 049
City
Bellevue
State/Province
Washington
ZIP/Postal Code
98402
Country
United States
Facility Name
Forest Investigative Site 098
City
Lakewood
State/Province
Washington
ZIP/Postal Code
98499
Country
United States
Facility Name
Forest Investigative Site 066
City
Wenatchee
State/Province
Washington
ZIP/Postal Code
98801
Country
United States
Facility Name
Forest Investigative Site 083
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53209
Country
United States
Facility Name
Forest Investigative Site 107
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
Forest Investigative Site 112
City
New Market
State/Province
Ontario
ZIP/Postal Code
L3Y 7V1
Country
Canada
Facility Name
Forest Investigative Site 106
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K2C 3R2
Country
Canada
Facility Name
Forest Investigative Site 115
City
Sarnia
State/Province
Ontario
ZIP/Postal Code
N7T 4X3
Country
Canada
Facility Name
Forest Investigative Site 113
City
Sudbury
State/Province
Ontario
ZIP/Postal Code
P3E 1H5
Country
Canada
Facility Name
Forest Investigative Site 008
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M3N 2V7
Country
Canada
Facility Name
Forest Investigative Site 116
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M4S 1Y2
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
24075889
Citation
Rao SS, Quigley EM, Shiff SJ, Lavins BJ, Kurtz CB, MacDougall JE, Currie MG, Johnston JM. Effect of linaclotide on severe abdominal symptoms in patients with irritable bowel syndrome with constipation. Clin Gastroenterol Hepatol. 2014 Apr;12(4):616-23. doi: 10.1016/j.cgh.2013.09.022. Epub 2013 Sep 25.
Results Reference
derived
PubMed Identifier
23116208
Citation
Quigley EM, Tack J, Chey WD, Rao SS, Fortea J, Falques M, Diaz C, Shiff SJ, Currie MG, Johnston JM. Randomised clinical trials: linaclotide phase 3 studies in IBS-C - a prespecified further analysis based on European Medicines Agency-specified endpoints. Aliment Pharmacol Ther. 2013 Jan;37(1):49-61. doi: 10.1111/apt.12123. Epub 2012 Nov 1.
Results Reference
derived

Learn more about this trial

Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation

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