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

NCT ID: NCT02559206

Last Updated: 2020-04-24

Study Results

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

759 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-10-22

Study Completion Date

2016-09-30

Brief Summary

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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).

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Detailed Description

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Conditions

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Irritable Bowel Syndrome With Constipation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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30 μg linaclotide DR1 and placebo

Group Type EXPERIMENTAL

Linaclotide

Intervention Type DRUG

Oral, once daily

100 μg linaclotide DR1 and placebo

Group Type EXPERIMENTAL

Linaclotide

Intervention Type DRUG

Oral, once daily

300 μg linaclotide DR1 and placebo

Group Type EXPERIMENTAL

Linaclotide

Intervention Type DRUG

Oral, once daily

30 μg linaclotide DR2 and placebo

Group Type EXPERIMENTAL

Linaclotide

Intervention Type DRUG

Oral, once daily

100 μg linaclotide DR2 and placebo

Group Type EXPERIMENTAL

Linaclotide

Intervention Type DRUG

Oral, once daily

300 μg linaclotide DR2 and placebo

Group Type EXPERIMENTAL

Linaclotide

Intervention Type DRUG

Oral, once daily

290 μg linaclotide IR and placebo

Group Type EXPERIMENTAL

Linaclotide

Intervention Type DRUG

Oral, once daily

Placebo

Group Type PLACEBO_COMPARATOR

Matching Placebo

Intervention Type DRUG

Oral, once daily

Interventions

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Linaclotide

Oral, once daily

Intervention Type DRUG

Matching Placebo

Oral, once daily

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Forest Laboratories

INDUSTRY

Sponsor Role collaborator

Ironwood Pharmaceuticals, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Paul Chamberlin, MD

Role: STUDY_CHAIR

Ironwood Pharmaceuticals, Inc.

Locations

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Ironwood Investigational Site

Huntsville, Alabama, United States

Site Status

Ironwood Investigational Site

Phoenix, Arizona, United States

Site Status

Ironwood Investigational Site

Tucson, Arizona, United States

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Ironwood Investigational Site

North Little Rock, Arkansas, United States

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Ironwood Investigational Site

Anaheim, California, United States

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Ironwood Investigational Site

Chula Vista, California, United States

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Ironwood Investigational Site

Garden Grove, California, United States

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Ironwood Investigational Site

La Mesa, California, United States

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Ironwood Investigational Site

Newport Beach, California, United States

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Ironwood Investigational Site

Orange, California, United States

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Ironwood Investigational Site

San Diego, California, United States

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Ironwood Investigational Site

Thousand Oaks, California, United States

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Ironwood Investigational Site

Colorado Springs, Colorado, United States

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Ironwood Investigational Site

Bristol, Connecticut, United States

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Ironwood Investigational Site

Waterbury, Connecticut, United States

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Ironwood Investigational Site

Hialeah, Florida, United States

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Ironwood Investigational Site

Kissimmee, Florida, United States

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Ironwood Investigational Site

Miami, Florida, United States

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Ironwood Investigational Site

Miami, Florida, United States

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Ironwood Investigational Site

Miami, Florida, United States

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Ironwood Investigational Site

Miami, Florida, United States

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Orlando, Florida, United States

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Ironwood Investigational Site

South Miami, Florida, United States

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Ironwood Investigational Site

Tampa, Florida, United States

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Ironwood Investigational Site

West Palm Beach, Florida, United States

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Ironwood Investigational Site

Atlanta, Georgia, United States

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Ironwood Investigational Site

Oakwood, Georgia, United States

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Ironwood Investigational Site

Sandy Springs, Georgia, United States

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Ironwood Investigational Site

Evansville, Indiana, United States

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Ironwood Investigational Site

Bastrop, Louisiana, United States

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Metairie, Louisiana, United States

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Ironwood Investigational Site

Shreveport, Louisiana, United States

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Ironwood Investigational Site

Baltimore, Maryland, United States

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Chevy Chase, Maryland, United States

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Boston, Massachusetts, United States

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Watertown, Massachusetts, United States

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Chesterfield, Michigan, United States

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Wyoming, Michigan, United States

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Jackson, Mississippi, United States

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St Louis, Missouri, United States

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Ironwood Investigational Site

Bozeman, Montana, United States

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Ironwood Investigational Site

Las Vegas, Nevada, United States

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Ironwood Investigational Site

Las Vegas, Nevada, United States

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Ironwood Investigational Site

Brooklyn, New York, United States

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Ironwood Investigational Site

Charlotte, North Carolina, United States

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Concord, North Carolina, United States

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Davidson, North Carolina, United States

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Fayetteville, North Carolina, United States

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Wilmington, North Carolina, United States

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Ironwood Investigational Site

Winston-Salem, North Carolina, United States

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Ironwood Investigational Site

Cincinnati, Ohio, United States

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Ironwood Investigational Site

Cincinnati, Ohio, United States

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Ironwood Investigational Site

Mentor, Ohio, United States

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Ironwood Investigational Site

Xenia, Ohio, United States

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Ironwood Investigational Site

Pittsburgh, Pennsylvania, United States

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Ironwood Investigational Site

Dakota Dunes, South Dakota, United States

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Ironwood Investigational Site

Bristol, Tennessee, United States

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Ironwood Investigational Site

Chattanooga, Tennessee, United States

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Ironwood Investigational Site

Knoxville, Tennessee, United States

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Ironwood Investigational Site

Arlington, Texas, United States

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Ironwood Investigational Site

Beaumont, Texas, United States

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Ironwood Investigational Site

El Paso, Texas, United States

Site Status

Ironwood Investigational Site

Houston, Texas, United States

Site Status

Ironwood Investigational Site

San Antonio, Texas, United States

Site Status

Ironwood Investigational Site

San Antonio, Texas, United States

Site Status

Ironwood Investigational Site

San Antonio, Texas, United States

Site Status

Ironwood Investigational Site

Ogden, Utah, United States

Site Status

Ironwood Investigational Site

Sandy City, Utah, United States

Site Status

Ironwood Investigational Site

Christiansburg, Virginia, United States

Site Status

Ironwood Investigational Site

Lynchburg, Virginia, United States

Site Status

Ironwood Investigational Site

La Crosse, Wisconsin, United States

Site Status

Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 33065589 (View on PubMed)

Provided Documents

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Document Type: Statistical Analysis Plan

View Document

Document Type: Study Protocol

View Document

Other Identifiers

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MCP-103-204

Identifier Type: -

Identifier Source: org_study_id

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