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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 2
Locations
United States
Study Type
Interventional
Intervention
Linaclotide
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

Eligibility Criteria

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

Inclusion Criteria:

  • Patient has completed a colonoscopy according to the American Gastroenterological Association (AGA) criteria, with no clinically significant findings
  • Patient has no clinically significant findings on a physical examination and clinical laboratory tests
  • Patient meets protocol criteria for diagnosis of IBS-C
  • Patient demonstrates continued IBS-C through Pretreatment Period
  • Patient maintains a minimum level of compliance with daily diary

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
  • 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 4

Arm 5

Arm 6

Arm 7

Arm 8

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

30 μg linaclotide DR1 and placebo

100 μg linaclotide DR1 and placebo

300 μg linaclotide DR1 and placebo

30 μg linaclotide DR2 and placebo

100 μg linaclotide DR2 and placebo

300 μg linaclotide DR2 and placebo

290 μg linaclotide IR and placebo

Placebo

Arm Description

Outcomes

Primary Outcome Measures

Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo
Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom "at its worst in past 24 hours." A participant's weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week.
Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR2 or IR vs. Placebo
Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom "at its worst in past 24 hours." A participant's weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week.
Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR1 or IR vs. Placebo
A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week.
Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR2 or IR vs. Placebo
A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week.
Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR1 or IR vs. Placebo
A 6/12 Week APC +1 Responder is a participant who meets the Weekly APC +1 Responder criteria for at least 6 out of the 12 weeks of the Treatment Period. Weekly APC +1 Responder: A participant who meets the criteria to be a Weekly Abdominal Pain Responder and a Weekly CSBM +1 Responder. Weekly Abdominal Pain Responder: A participant who has a decrease from baseline of ≥30% in the mean daily worst abdominal pain scores for that week. Weekly CSBM +1 Responder: A participant who has an increase from baseline of ≥1 in the CSBM weekly rate for that week. A participant with <4 days of completed eDiary data for that week is not considered a responder for that week.
Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR2 or IR vs. Placebo
A 6/12 Week APC +1 Responder is a participant who meets the Weekly APC +1 Responder criteria for at least 6 out of the 12 weeks of the Treatment Period. Weekly APC +1 Responder: A participant who meets the criteria to be a Weekly Abdominal Pain Responder and a Weekly CSBM +1 Responder. Weekly Abdominal Pain Responder: A participant who has a decrease from baseline of ≥30% in the mean daily worst abdominal pain scores for that week. Weekly CSBM +1 Responder: A participant who has an increase from baseline of ≥1 in the CSBM weekly rate for that week. A participant with <4 days of completed eDiary data for that week is not considered a responder for that week.

Secondary Outcome Measures

Full Information

First Posted
September 22, 2015
Last Updated
April 9, 2020
Sponsor
Ironwood Pharmaceuticals, Inc.
Collaborators
Forest Laboratories
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1. Study Identification

Unique Protocol Identification Number
NCT02559206
Brief Title
Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Official Title
A Phase 2b, Randomized, Double-blind, Double-dummy, Placebo-controlled, Parallel-group, Dose-range-finding Study of Two Delayed Release Formulations of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation
Study Type
Interventional

2. Study Status

Record Verification Date
April 2020
Overall Recruitment Status
Completed
Study Start Date
October 22, 2015 (Actual)
Primary Completion Date
September 30, 2016 (Actual)
Study Completion Date
September 30, 2016 (Actual)

3. Sponsor/Collaborators

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

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The objectives of this study are to evaluate the safety, efficacy, and dose response of two delayed release formulations of linaclotide (DR; DR formulation 1 is DR1; DR formulation 2 is DR2) administered orally to patients with irritable bowel syndrome with constipation (IBS-C). Additional objectives include understanding how the two DR formulations compare with each other and with the FDA-approved 290 μg LINZESS® (the immediate release [IR] formulation of linaclotide).

6. Conditions and Keywords

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

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
759 (Actual)

8. Arms, Groups, and Interventions

Arm Title
30 μg linaclotide DR1 and placebo
Arm Type
Experimental
Arm Title
100 μg linaclotide DR1 and placebo
Arm Type
Experimental
Arm Title
300 μg linaclotide DR1 and placebo
Arm Type
Experimental
Arm Title
30 μg linaclotide DR2 and placebo
Arm Type
Experimental
Arm Title
100 μg linaclotide DR2 and placebo
Arm Type
Experimental
Arm Title
300 μg linaclotide DR2 and placebo
Arm Type
Experimental
Arm Title
290 μg linaclotide IR and placebo
Arm Type
Experimental
Arm Title
Placebo
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Linaclotide
Intervention Description
Oral, once daily
Intervention Type
Drug
Intervention Name(s)
Matching Placebo
Intervention Description
Oral, once daily
Primary Outcome Measure Information:
Title
Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo
Description
Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom "at its worst in past 24 hours." A participant's weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week.
Time Frame
Baseline, up to Week 12
Title
Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR2 or IR vs. Placebo
Description
Abdominal pain assessment was based on an 11-point numerical rating scale (0=No symptom; 10=Worst possible) assessing the symptom "at its worst in past 24 hours." A participant's weekly abdominal pain score is the average of the nonmissing abdominal pain scores reported by the participant during each week.
Time Frame
Baseline, up to Week 12
Title
Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR1 or IR vs. Placebo
Description
A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week.
Time Frame
Baseline, up to Week 12
Title
Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR2 or IR vs. Placebo
Description
A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week.
Time Frame
Baseline, up to Week 12
Title
Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR1 or IR vs. Placebo
Description
A 6/12 Week APC +1 Responder is a participant who meets the Weekly APC +1 Responder criteria for at least 6 out of the 12 weeks of the Treatment Period. Weekly APC +1 Responder: A participant who meets the criteria to be a Weekly Abdominal Pain Responder and a Weekly CSBM +1 Responder. Weekly Abdominal Pain Responder: A participant who has a decrease from baseline of ≥30% in the mean daily worst abdominal pain scores for that week. Weekly CSBM +1 Responder: A participant who has an increase from baseline of ≥1 in the CSBM weekly rate for that week. A participant with <4 days of completed eDiary data for that week is not considered a responder for that week.
Time Frame
up to Week 12
Title
Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR2 or IR vs. Placebo
Description
A 6/12 Week APC +1 Responder is a participant who meets the Weekly APC +1 Responder criteria for at least 6 out of the 12 weeks of the Treatment Period. Weekly APC +1 Responder: A participant who meets the criteria to be a Weekly Abdominal Pain Responder and a Weekly CSBM +1 Responder. Weekly Abdominal Pain Responder: A participant who has a decrease from baseline of ≥30% in the mean daily worst abdominal pain scores for that week. Weekly CSBM +1 Responder: A participant who has an increase from baseline of ≥1 in the CSBM weekly rate for that week. A participant with <4 days of completed eDiary data for that week is not considered a responder for that week.
Time Frame
up 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 American Gastroenterological Association (AGA) criteria, with no clinically significant findings Patient has no clinically significant findings on a physical examination and clinical laboratory tests Patient meets protocol criteria for diagnosis of IBS-C Patient demonstrates continued IBS-C through Pretreatment Period Patient maintains a minimum level of compliance with daily diary 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
Paul Chamberlin, MD
Organizational Affiliation
Ironwood Pharmaceuticals, Inc.
Official's Role
Study Chair
Facility Information:
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
85018
Country
United States
Facility Name
Ironwood Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85712
Country
United States
Facility Name
Ironwood Investigational Site
City
North Little Rock
State/Province
Arkansas
ZIP/Postal Code
72117
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
Garden Grove
State/Province
California
ZIP/Postal Code
92843
Country
United States
Facility Name
Ironwood Investigational Site
City
La Mesa
State/Province
California
ZIP/Postal Code
91942
Country
United States
Facility Name
Ironwood Investigational Site
City
Newport Beach
State/Province
California
ZIP/Postal Code
92660
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 Diego
State/Province
California
ZIP/Postal Code
92108
Country
United States
Facility Name
Ironwood Investigational Site
City
Thousand Oaks
State/Province
California
ZIP/Postal Code
91360
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
Waterbury
State/Province
Connecticut
ZIP/Postal Code
06708
Country
United States
Facility Name
Ironwood Investigational Site
City
Hialeah
State/Province
Florida
ZIP/Postal Code
33016
Country
United States
Facility Name
Ironwood Investigational Site
City
Kissimmee
State/Province
Florida
ZIP/Postal Code
34744
Country
United States
Facility Name
Ironwood Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33015
Country
United States
Facility Name
Ironwood Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33135
Country
United States
Facility Name
Ironwood Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33165
Country
United States
Facility Name
Ironwood Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33175
Country
United States
Facility Name
Ironwood Investigational Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Facility Name
Ironwood Investigational Site
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Ironwood Investigational Site
City
Tampa
State/Province
Florida
ZIP/Postal Code
33634
Country
United States
Facility Name
Ironwood Investigational Site
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33409
Country
United States
Facility Name
Ironwood Investigational Site
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Ironwood Investigational Site
City
Oakwood
State/Province
Georgia
ZIP/Postal Code
30566
Country
United States
Facility Name
Ironwood Investigational Site
City
Sandy Springs
State/Province
Georgia
ZIP/Postal Code
30328
Country
United States
Facility Name
Ironwood Investigational Site
City
Evansville
State/Province
Indiana
ZIP/Postal Code
47714
Country
United States
Facility Name
Ironwood Investigational Site
City
Bastrop
State/Province
Louisiana
ZIP/Postal Code
71220
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
Shreveport
State/Province
Louisiana
ZIP/Postal Code
71105
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
Chevy Chase
State/Province
Maryland
ZIP/Postal Code
20815
Country
United States
Facility Name
Ironwood Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02131
Country
United States
Facility Name
Ironwood Investigational Site
City
Watertown
State/Province
Massachusetts
ZIP/Postal Code
02472
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
Wyoming
State/Province
Michigan
ZIP/Postal Code
49519
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
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63128-2197
Country
United States
Facility Name
Ironwood Investigational Site
City
Bozeman
State/Province
Montana
ZIP/Postal Code
59718
Country
United States
Facility Name
Ironwood Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Ironwood Investigational Site
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89121
Country
United States
Facility Name
Ironwood Investigational Site
City
Brooklyn
State/Province
New York
ZIP/Postal Code
11206
Country
United States
Facility Name
Ironwood Investigational Site
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28210
Country
United States
Facility Name
Ironwood Investigational Site
City
Concord
State/Province
North Carolina
ZIP/Postal Code
28025
Country
United States
Facility Name
Ironwood Investigational Site
City
Davidson
State/Province
North Carolina
ZIP/Postal Code
28036
Country
United States
Facility Name
Ironwood Investigational Site
City
Fayetteville
State/Province
North Carolina
ZIP/Postal Code
28304
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
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
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
Mentor
State/Province
Ohio
ZIP/Postal Code
44060
Country
United States
Facility Name
Ironwood Investigational Site
City
Xenia
State/Province
Ohio
ZIP/Postal Code
45385
Country
United States
Facility Name
Ironwood Investigational Site
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15206
Country
United States
Facility Name
Ironwood Investigational Site
City
Dakota Dunes
State/Province
South Dakota
ZIP/Postal Code
57049
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
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37909
Country
United States
Facility Name
Ironwood Investigational Site
City
Arlington
State/Province
Texas
ZIP/Postal Code
76012
Country
United States
Facility Name
Ironwood Investigational Site
City
Beaumont
State/Province
Texas
ZIP/Postal Code
77001
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
77074
Country
United States
Facility Name
Ironwood Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78209
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
San Antonio
State/Province
Texas
ZIP/Postal Code
78258
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
Sandy
State/Province
Utah
ZIP/Postal Code
84094
Country
United States
Facility Name
Ironwood Investigational Site
City
Christiansburg
State/Province
Virginia
ZIP/Postal Code
24073
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
La Crosse
State/Province
Wisconsin
ZIP/Postal Code
54601
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
33065589
Citation
Chey WD, Sayuk GS, Bartolini W, Reasner DS, Fox SM, Bochenek W, Boinpally R, Shea E, Tripp K, Borgstein N. Randomized Trial of 2 Delayed-Release Formulations of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation. Am J Gastroenterol. 2021 Feb 1;116(2):354-361. doi: 10.14309/ajg.0000000000000967.
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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