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Trial of Linaclotide in Patients With Chronic Constipation

Primary Purpose

Chronic Constipation

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

About this trial

This is an interventional treatment trial for Chronic Constipation

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

  • 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
  • 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 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

145 μg linaclotide

290 μg linaclotide

Matching Placebo

Arm Description

Outcomes

Primary Outcome Measures

Complete Spontaneous Bowel Movement (CSBM) Overall Responder
A 12-week CSBM Overall Responder 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
The number of CSBMs per week.
12-Week Spontaneous Bowl Movement (SBM) Frequency
The number of SBMs per week.
12-week Change in 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 Change in Severity of Straining
Severity of 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 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 Change in 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 Change in 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
August 5, 2008
Last Updated
December 19, 2012
Sponsor
Ironwood Pharmaceuticals, Inc.
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT00730015
Brief Title
Trial of Linaclotide in Patients With Chronic Constipation
Official Title
A Phase 3, 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 Chronic Constipation
Study Type
Interventional

2. Study Status

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

7. Study Design

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

8. Arms, Groups, and Interventions

Arm Title
145 μg linaclotide
Arm Type
Experimental
Arm Title
290 μg linaclotide
Arm Type
Experimental
Arm Title
Matching Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Description
Oral, once daily
Intervention Type
Drug
Intervention Name(s)
Linaclotide
Intervention Description
Oral, once daily
Primary Outcome Measure Information:
Title
Complete Spontaneous Bowel Movement (CSBM) Overall Responder
Description
A 12-week CSBM Overall Responder 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
Description
The number of CSBMs per week.
Time Frame
Change from Baseline to Week 12
Title
12-Week Spontaneous Bowl Movement (SBM) Frequency
Description
The number of SBMs per week.
Time Frame
Change from Baseline to Week 12
Title
12-week Change in 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 Change in Severity of Straining
Description
Severity of 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 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 Change in 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 Change in 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
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
Chandler
State/Province
Arizona
ZIP/Postal Code
85224
Country
United States
Facility Name
Ironwood Investigational Site
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85020
Country
United States
Facility Name
Ironwood Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85715
Country
United States
Facility Name
Ironwood Investigational Site
City
Tuscon
State/Province
Arizona
ZIP/Postal Code
85710
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
Los Angeles
State/Province
California
ZIP/Postal Code
90045
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
Sacramento
State/Province
California
ZIP/Postal Code
95830
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
06010
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
32256
Country
United States
Facility Name
Ironwood Investigational Site
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32129
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
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
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
Henderson
State/Province
Nevada
ZIP/Postal Code
89104
Country
United States
Facility Name
Ironwood Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89128
Country
United States
Facility Name
Ironwood Investigational Site
City
Cedar Knolls
State/Province
New Jersey
ZIP/Postal Code
07927
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
Ocean
State/Province
New Jersey
ZIP/Postal Code
07712
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
28211
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
Jacksonville
State/Province
North Carolina
ZIP/Postal Code
28546
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
Summerville
State/Province
North Carolina
ZIP/Postal Code
29485
Country
United States
Facility Name
Ironwood Investigational Site
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28401
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
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
Zanesville
State/Province
Ohio
ZIP/Postal Code
43701
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
Lancaster
State/Province
Pennsylvania
ZIP/Postal Code
19606
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
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
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
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
29681
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
37421
Country
United States
Facility Name
Ironwood Investigational Site
City
Germantown
State/Province
Tennessee
ZIP/Postal Code
38138
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
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
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
LaCrosse
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
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

Trial of Linaclotide in Patients With Chronic Constipation

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