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Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Primary Purpose

Irritable Bowel Syndrome With Constipation

Status
Completed
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Linaclotide or Matching Placebo
Sponsored by
Ironwood Pharmaceuticals, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome With Constipation focused on measuring IBS

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 diagnosis of IBS-C
  • Patient demonstrates continued IBS-C 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 a medical condition that may contribute to abdominal pain
  • 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

  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
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  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site
  • Ironwood Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo

290 μg Linaclotide

Arm Description

Outcomes

Primary Outcome Measures

Abdominal Pain and Complete Spontaneous Bowel Movement (APC) Responder, 9 Out of 12 Weeks
A patient is considered to be a 9 out of 12 week APC responder if, for at least 9 out of the first 12 weeks of the treatment period, the patient had at least 3 CSBMs, had an increase of at least 1 CSBM from baseline, and had a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week. The AP score assesses patient's worst 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. SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use on either the calendar day of the bowel movement or the calendar day before the bowel movement. CSBM is defined as an SBM 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 patient's worst 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 to be a 6 out of 12 week APC responder if, for at least 6 out of the first 12 weeks of the treatment period, the patient had an increase of at least 1 CSBM from baseline, and had a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week. The AP score assesses patient's worst 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. SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use on either the calendar day of the bowel movement or the calendar day before the bowel movement. CSBM is defined as an SBM associated with a sense of complete evacuation.

Secondary Outcome Measures

12-Week Complete Spontaneous Bowel Movement (CSBM) Frequency
The change from baseline in 12-week CSBM frequency (i.e., weekly CSBM frequency over the first 12 weeks of the Treatment Period).
12-Week Spontaneous Bowl Movement (SBM) Frequency
The change from baseline in 12-week SBM frequency (i.e., weekly SBM frequency over the first 12 weeks of the Treatment Period).
12-Week Change in 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 Change in 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 was assessed 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 AP responder if, for at least 6 out of the first 12 weeks of the treatment period, the patient had a decrease of at least 30 percent in their Abdominal Pain score from baseline during a particular week.
12-Week Percent of Abdominal Pain-free 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 12, 2009
Last Updated
October 9, 2013
Sponsor
Ironwood Pharmaceuticals, Inc.
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00938717
Brief Title
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Official Title
A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Trial of Linaclotide Administered Orally for 26 Weeks in Patients With Irritable Bowel Syndrome With Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
October 2013
Overall Recruitment Status
Completed
Study Start Date
July 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

5. Study Description

Brief Summary
The purpose of this study is to determine the safety and efficacy of linaclotide administered to patients with Irritable Bowel Syndrome with Constipation (IBS-C).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome With Constipation
Keywords
IBS

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Title
290 μg Linaclotide
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Linaclotide or Matching Placebo
Intervention Description
Linaclotide or Matching Placebo, administered orally, once daily, for the duration of the trial
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 a 9 out of 12 week APC responder if, for at least 9 out of the first 12 weeks of the treatment period, the patient had at least 3 CSBMs, had an increase of at least 1 CSBM from baseline, and had a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week. The AP score assesses patient's worst 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. SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use on either the calendar day of the bowel movement or the calendar day before the bowel movement. CSBM is defined as an SBM 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 patient's worst 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 to be a 6 out of 12 week APC responder if, for at least 6 out of the first 12 weeks of the treatment period, the patient had an increase of at least 1 CSBM from baseline, and had a decrease of at least 30 percent in their Abdominal Pain (AP) score from baseline during a particular week. The AP score assesses patient's worst 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. SBM is defined as a bowel movement that occurs in the absence of laxative, enema, or suppository use on either the calendar day of the bowel movement or the calendar day before the bowel movement. CSBM is defined as an SBM 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
Description
The change from baseline in 12-week CSBM frequency (i.e., weekly CSBM frequency over the first 12 weeks of the Treatment Period).
Time Frame
Change from Baseline to Week 12
Title
12-Week Spontaneous Bowl Movement (SBM) Frequency
Description
The change from baseline in 12-week SBM frequency (i.e., weekly SBM frequency over the first 12 weeks of the Treatment Period).
Time Frame
Change from Baseline to Week 12
Title
12-Week Change in 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 Change in 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 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
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 AP responder if, for at least 6 out of the first 12 weeks of the treatment period, the patient had a decrease of at least 30 percent in their Abdominal Pain score from baseline during a particular week.
Time Frame
Change from Baseline to Week 12
Title
12-Week Percent of Abdominal Pain-free 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 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 diagnosis of IBS-C Patient demonstrates continued IBS-C 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 a medical condition that may contribute to abdominal pain 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
Jeffrey M. Johnston, MD, FACP
Organizational Affiliation
Ironwood Pharmaceuticals, Inc.
Official's Role
Study Chair
Facility Information:
Facility Name
Ironwood Investigational Site
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35209
Country
United States
Facility Name
Ironwood Investigational Site
City
Huntsville
State/Province
Alabama
ZIP/Postal Code
35801
Country
United States
Facility Name
Ironwood Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85014
Country
United States
Facility Name
Ironwood Investigational Site
City
Tempe
State/Province
Arizona
ZIP/Postal Code
85282
Country
United States
Facility Name
Ironwood Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
Ironwood Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85741
Country
United States
Facility Name
Ironwood Investigational Site
City
Sherwood
State/Province
Arkansas
ZIP/Postal Code
72120
Country
United States
Facility Name
Ironwood Investigational Site
City
Anaheim
State/Province
California
ZIP/Postal Code
92801
Country
United States
Facility Name
Ironwood Investigational Site
City
Chula Vista
State/Province
California
ZIP/Postal Code
91910
Country
United States
Facility Name
Ironwood Investigational Site
City
Encinitas
State/Province
California
ZIP/Postal Code
92024
Country
United States
Facility Name
Ironwood Investigational Site
City
Garden Grove
State/Province
California
ZIP/Postal Code
92840
Country
United States
Facility Name
Ironwood Investigational Site
City
Laguna Hills
State/Province
California
ZIP/Postal Code
92653
Country
United States
Facility Name
Ironwood Investigational Site
City
Orange
State/Province
California
ZIP/Postal Code
92868
Country
United States
Facility Name
Ironwood Investigational Site
City
San Carlos
State/Province
California
ZIP/Postal Code
94070
Country
United States
Facility Name
Ironwood Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92103
Country
United States
Facility Name
Ironwood Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Ironwood Investigational Site
City
San Diego
State/Province
California
ZIP/Postal Code
92123
Country
United States
Facility Name
Ironwood Investigational Site
City
Colorado Springs
State/Province
Colorado
ZIP/Postal Code
80904
Country
United States
Facility Name
Ironwood Investigational Site
City
Bristol
State/Province
Connecticut
ZIP/Postal Code
06011
Country
United States
Facility Name
Ironwood Investigational Site
City
Boynton Beach
State/Province
Florida
ZIP/Postal Code
33426
Country
United States
Facility Name
Ironwood Investigational Site
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Ironwood Investigational Site
City
Inverness
State/Province
Florida
ZIP/Postal Code
34452
Country
United States
Facility Name
Ironwood Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32205
Country
United States
Facility Name
Ironwood Investigational Site
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32207
Country
United States
Facility Name
Ironwood Investigational Site
City
Lauderdale Lakes
State/Province
Florida
ZIP/Postal Code
33319
Country
United States
Facility Name
Ironwood Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33156
Country
United States
Facility Name
Ironwood Investigational Site
City
Pinellas Park
State/Province
Florida
ZIP/Postal Code
33782
Country
United States
Facility Name
Ironwood Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33607
Country
United States
Facility Name
Ironwood Investigational Site
City
Newnan
State/Province
Georgia
ZIP/Postal Code
30263
Country
United States
Facility Name
Ironwood Investigational Site
City
Peoria
State/Province
Illinois
ZIP/Postal Code
61602
Country
United States
Facility Name
Ironwood Investigational Site
City
Anderson
State/Province
Indiana
ZIP/Postal Code
46011
Country
United States
Facility Name
Ironwood Investigational Site
City
Clive
State/Province
Iowa
ZIP/Postal Code
50325
Country
United States
Facility Name
Ironwood Investigational Site
City
Davenport
State/Province
Iowa
ZIP/Postal Code
52807
Country
United States
Facility Name
Ironwood Investigational Site
City
Mission
State/Province
Kansas
ZIP/Postal Code
66202
Country
United States
Facility Name
Ironwood Investigational Site
City
Overland Park
State/Province
Kansas
ZIP/Postal Code
66215
Country
United States
Facility Name
Ironwood Investigational Site
City
Topeka
State/Province
Kansas
ZIP/Postal Code
66606
Country
United States
Facility Name
Ironwood Investigational Site
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Ironwood Investigational Site
City
Metairie
State/Province
Louisiana
ZIP/Postal Code
70006
Country
United States
Facility Name
Ironwood Investigational Site
City
Monroe
State/Province
Louisiana
ZIP/Postal Code
71201
Country
United States
Facility Name
Ironwood Investigational Site
City
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71103
Country
United States
Facility Name
Ironwood Investigational Site
City
Annapolis
State/Province
Maryland
ZIP/Postal Code
21401
Country
United States
Facility Name
Ironwood Investigational Site
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21215
Country
United States
Facility Name
Ironwood Investigational Site
City
Hollywood
State/Province
Maryland
ZIP/Postal Code
20636
Country
United States
Facility Name
Ironwood Investigational Site
City
Laurel
State/Province
Maryland
ZIP/Postal Code
20707
Country
United States
Facility Name
Ironwood Investigational Site
City
Chesterfield
State/Province
Michigan
ZIP/Postal Code
48047
Country
United States
Facility Name
Ironwood Investigational Site
City
Traverse City
State/Province
Michigan
ZIP/Postal Code
49684
Country
United States
Facility Name
Ironwood Investigational Site
City
Troy
State/Province
Michigan
ZIP/Postal Code
48098
Country
United States
Facility Name
Ironwood Investigational Site
City
Plymouth
State/Province
Minnesota
ZIP/Postal Code
55446
Country
United States
Facility Name
Ironwood Investigational Site
City
Jackson
State/Province
Mississippi
ZIP/Postal Code
39202
Country
United States
Facility Name
Ironwood Investigational Site
City
Tupelo
State/Province
Mississippi
ZIP/Postal Code
38801
Country
United States
Facility Name
Ironwood Investigational Site
City
Jefferson City
State/Province
Missouri
ZIP/Postal Code
65109
Country
United States
Facility Name
Ironwood Investigational Site
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Facility Name
Ironwood Investigational Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87108
Country
United States
Facility Name
Ironwood Investigational Site
City
Mineola
State/Province
New York
ZIP/Postal Code
11501
Country
United States
Facility Name
Ironwood Investigational Site
City
Pittsford
State/Province
New York
ZIP/Postal Code
14534
Country
United States
Facility Name
Ironwood Investigational Site
City
Asheboro
State/Province
North Carolina
ZIP/Postal Code
27203
Country
United States
Facility Name
Ironwood Investigational Site
City
Asheville
State/Province
North Carolina
ZIP/Postal Code
28801
Country
United States
Facility Name
Ironwood Investigational Site
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
Facility Name
Ironwood Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28209
Country
United States
Facility Name
Ironwood Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211
Country
United States
Facility Name
Ironwood Investigational Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27401
Country
United States
Facility Name
Ironwood Investigational Site
City
Greensboro
State/Province
North Carolina
ZIP/Postal Code
27408
Country
United States
Facility Name
Ironwood Investigational Site
City
Harrisburg
State/Province
North Carolina
ZIP/Postal Code
28075
Country
United States
Facility Name
Ironwood Investigational Site
City
Hickory
State/Province
North Carolina
ZIP/Postal Code
28602
Country
United States
Facility Name
Ironwood Investigational Site
City
Huntersville
State/Province
North Carolina
ZIP/Postal Code
28078
Country
United States
Facility Name
Ironwood Investigational Site
City
New Bern
State/Province
North Carolina
ZIP/Postal Code
28562
Country
United States
Facility Name
Ironwood Investigational Site
City
Statesville
State/Province
North Carolina
ZIP/Postal Code
28625
Country
United States
Facility Name
Ironwood Investigational Site
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Ironwood Investigational Site
City
Beachwood
State/Province
Ohio
ZIP/Postal Code
44122
Country
United States
Facility Name
Ironwood Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45224
Country
United States
Facility Name
Ironwood Investigational Site
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45242
Country
United States
Facility Name
Ironwood Investigational Site
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45440
Country
United States
Facility Name
Ironwood Investigational Site
City
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Ironwood Investigational Site
City
Sylvania
State/Province
Ohio
ZIP/Postal Code
43560
Country
United States
Facility Name
Ironwood Investigational Site
City
Wadsworth
State/Province
Ohio
ZIP/Postal Code
44281
Country
United States
Facility Name
Ironwood Investigational Site
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73116
Country
United States
Facility Name
Ironwood Investigational Site
City
Yukon
State/Province
Oklahoma
ZIP/Postal Code
73099
Country
United States
Facility Name
Ironwood Investigational Site
City
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
17604
Country
United States
Facility Name
Ironwood Investigational Site
City
Levittown
State/Province
Pennsylvania
ZIP/Postal Code
19056
Country
United States
Facility Name
Ironwood Investigational Site
City
Reading
State/Province
Pennsylvania
ZIP/Postal Code
19606
Country
United States
Facility Name
Ironwood Investigational Site
City
Sellersville
State/Province
Pennsylvania
ZIP/Postal Code
18960
Country
United States
Facility Name
Ironwood Investigational Site
City
Washington
State/Province
Pennsylvania
ZIP/Postal Code
15301
Country
United States
Facility Name
Ironwood Investigational Site
City
Anderson
State/Province
South Carolina
ZIP/Postal Code
29621
Country
United States
Facility Name
Ironwood Investigational Site
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29414
Country
United States
Facility Name
Ironwood Investigational Site
City
Simpsonville
State/Province
South Carolina
ZIP/Postal Code
29581
Country
United States
Facility Name
Ironwood Investigational Site
City
Summerville
State/Province
South Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Ironwood Investigational Site
City
Bristol
State/Province
Tennessee
ZIP/Postal Code
37620
Country
United States
Facility Name
Ironwood Investigational Site
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37404
Country
United States
Facility Name
Ironwood Investigational Site
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38183
Country
United States
Facility Name
Ironwood Investigational Site
City
Kingsport
State/Province
Tennessee
ZIP/Postal Code
37660
Country
United States
Facility Name
Ironwood Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
Ironwood Investigational Site
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77701
Country
United States
Facility Name
Ironwood Investigational Site
City
El Paso
State/Province
Texas
ZIP/Postal Code
79905
Country
United States
Facility Name
Ironwood Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
Ironwood Investigational Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77024
Country
United States
Facility Name
Ironwood Investigational Site
City
Irving
State/Province
Texas
ZIP/Postal Code
75061
Country
United States
Facility Name
Ironwood Investigational Site
City
Longview
State/Province
Texas
ZIP/Postal Code
75605
Country
United States
Facility Name
Ironwood Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
Facility Name
Ironwood Investigational Site
City
Sugarland
State/Province
Texas
ZIP/Postal Code
77479
Country
United States
Facility Name
Ironwood Investigational Site
City
Ogden
State/Province
Utah
ZIP/Postal Code
84405
Country
United States
Facility Name
Ironwood Investigational Site
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84107
Country
United States
Facility Name
Ironwood Investigational Site
City
Chesapeake
State/Province
Virginia
ZIP/Postal Code
23320
Country
United States
Facility Name
Ironwood Investigational Site
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24502
Country
United States
Facility Name
Ironwood Investigational Site
City
Spokane
State/Province
Washington
ZIP/Postal Code
99208
Country
United States
Facility Name
Ironwood Investigational Site
City
Vancouver
State/Province
Washington
ZIP/Postal Code
98664
Country
United States
Facility Name
Ironwood Investigational Site
City
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States
Facility Name
Ironwood Investigational Site
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53215
Country
United States

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 in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

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