Clinical trial NCT02559206: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Irritable Bowel Syndrome With Constipation
Lead sponsor: Ironwood Pharmaceuticals, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Forest Laboratories
First posted: 2015-09-24
Enrollment: 759
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).


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

Primary outcomes:
measure: Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo
timeFrame: Baseline, up to Week 12
measure: Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR2 or IR vs. Placebo
timeFrame: Baseline, up to Week 12
measure: Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR1 or IR vs. Placebo
timeFrame: Baseline, up to Week 12
measure: Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR2 or IR vs. Placebo
timeFrame: Baseline, up to Week 12
measure: Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR1 or IR vs. Placebo
timeFrame: up to Week 12
measure: Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR2 or IR vs. Placebo
timeFrame: up to Week 12
Secondary outcomes:
Other outcomes:
Locations:
city: Huntsville
country: United States
facility: Ironwood Investigational Site
state: Alabama
city: Phoenix
country: United States
facility: Ironwood Investigational Site
state: Arizona
city: Tucson
country: United States
facility: Ironwood Investigational Site
state: Arizona
city: North Little Rock
country: United States
facility: Ironwood Investigational Site
state: Arkansas
city: Anaheim
country: United States
facility: Ironwood Investigational Site
state: California
city: Chula Vista
country: United States
facility: Ironwood Investigational Site
state: California
city: Garden Grove
country: United States
facility: Ironwood Investigational Site
state: California
city: La Mesa
country: United States
facility: Ironwood Investigational Site
state: California
city: Newport Beach
country: United States
facility: Ironwood Investigational Site
state: California
city: Orange
country: United States
facility: Ironwood Investigational Site
state: California
city: San Diego
country: United States
facility: Ironwood Investigational Site
state: California
city: Thousand Oaks
country: United States
facility: Ironwood Investigational Site
state: California
city: Colorado Springs
country: United States
facility: Ironwood Investigational Site
state: Colorado
city: Bristol
country: United States
facility: Ironwood Investigational Site
state: Connecticut
city: Waterbury
country: United States
facility: Ironwood Investigational Site
state: Connecticut
city: Hialeah
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Kissimmee
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Miami
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Miami
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Miami
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Miami
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Orlando
country: United States
facility: Ironwood Investigational Site
state: Florida
city: South Miami
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Tampa
country: United States
facility: Ironwood Investigational Site
state: Florida
city: West Palm Beach
country: United States
facility: Ironwood Investigational Site
state: Florida
city: Atlanta
country: United States
facility: Ironwood Investigational Site
state: Georgia
city: Oakwood
country: United States
facility: Ironwood Investigational Site
state: Georgia
city: Sandy Springs
country: United States
facility: Ironwood Investigational Site
state: Georgia
city: Evansville
country: United States
facility: Ironwood Investigational Site
state: Indiana
city: Bastrop
country: United States
facility: Ironwood Investigational Site
state: Louisiana
city: Metairie
country: United States
facility: Ironwood Investigational Site
state: Louisiana
city: Shreveport
country: United States
facility: Ironwood Investigational Site
state: Louisiana
city: Baltimore
country: United States
facility: Ironwood Investigational Site
state: Maryland
city: Chevy Chase
country: United States
facility: Ironwood Investigational Site
state: Maryland
city: Boston
country: United States
facility: Ironwood Investigational Site
state: Massachusetts
city: Watertown
country: United States
facility: Ironwood Investigational Site
state: Massachusetts
city: Chesterfield
country: United States
facility: Ironwood Investigational Site
state: Michigan
city: Wyoming
country: United States
facility: Ironwood Investigational Site
state: Michigan
city: Jackson
country: United States
facility: Ironwood Investigational Site
state: Mississippi
city: Saint Louis
country: United States
facility: Ironwood Investigational Site
state: Missouri
city: Bozeman
country: United States
facility: Ironwood Investigational Site
state: Montana
city: Las Vegas
country: United States
facility: Ironwood Investigational Site
state: Nevada
city: Las Vegas
country: United States
facility: Ironwood Investigational Site
state: Nevada
city: Brooklyn
country: United States
facility: Ironwood Investigational Site
state: New York
city: Charlotte
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Concord
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Davidson
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Fayetteville
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Wilmington
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Ironwood Investigational Site
state: North Carolina
city: Cincinnati
country: United States
facility: Ironwood Investigational Site
state: Ohio
city: Cincinnati
country: United States
facility: Ironwood Investigational Site
state: Ohio
city: Mentor
country: United States
facility: Ironwood Investigational Site
state: Ohio
city: Xenia
country: United States
facility: Ironwood Investigational Site
state: Ohio
city: Pittsburgh
country: United States
facility: Ironwood Investigational Site
state: Pennsylvania
city: Dakota Dunes
country: United States
facility: Ironwood Investigational Site
state: South Dakota
city: Bristol
country: United States
facility: Ironwood Investigational Site
state: Tennessee
city: Chattanooga
country: United States
facility: Ironwood Investigational Site
state: Tennessee
city: Knoxville
country: United States
facility: Ironwood Investigational Site
state: Tennessee
city: Arlington
country: United States
facility: Ironwood Investigational Site
state: Texas
city: Beaumont
country: United States
facility: Ironwood Investigational Site
state: Texas
city: El Paso
country: United States
facility: Ironwood Investigational Site
state: Texas
city: Houston
country: United States
facility: Ironwood Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Ironwood Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Ironwood Investigational Site
state: Texas
city: San Antonio
country: United States
facility: Ironwood Investigational Site
state: Texas
city: Ogden
country: United States
facility: Ironwood Investigational Site
state: Utah
city: Sandy
country: United States
facility: Ironwood Investigational Site
state: Utah
city: Christiansburg
country: United States
facility: Ironwood Investigational Site
state: Virginia
city: Lynchburg
country: United States
facility: Ironwood Investigational Site
state: Virginia
city: La Crosse
country: United States
facility: Ironwood Investigational Site
state: Wisconsin
Study officials:
affiliation: Ironwood Pharmaceuticals, Inc.
name: Paul Chamberlin, MD
role: STUDY_CHAIR
References:
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.