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

April 9, 2020 updated by: Ironwood Pharmaceuticals, Inc.

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

759

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Huntsville, Alabama, United States, 35801
        • Ironwood Investigational Site
    • Arizona
      • Phoenix, Arizona, United States, 85018
        • Ironwood Investigational Site
      • Tucson, Arizona, United States, 85712
        • Ironwood Investigational Site
    • Arkansas
      • North Little Rock, Arkansas, United States, 72117
        • Ironwood Investigational Site
    • California
      • Anaheim, California, United States, 92801
        • Ironwood Investigational Site
      • Chula Vista, California, United States, 91910
        • Ironwood Investigational Site
      • Garden Grove, California, United States, 92843
        • Ironwood Investigational Site
      • La Mesa, California, United States, 91942
        • Ironwood Investigational Site
      • Newport Beach, California, United States, 92660
        • Ironwood Investigational Site
      • Orange, California, United States, 92868
        • Ironwood Investigational Site
      • San Diego, California, United States, 92108
        • Ironwood Investigational Site
      • Thousand Oaks, California, United States, 91360
        • Ironwood Investigational Site
    • Colorado
      • Colorado Springs, Colorado, United States, 80904
        • Ironwood Investigational Site
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Ironwood Investigational Site
      • Waterbury, Connecticut, United States, 06708
        • Ironwood Investigational Site
    • Florida
      • Hialeah, Florida, United States, 33016
        • Ironwood Investigational Site
      • Kissimmee, Florida, United States, 34744
        • Ironwood Investigational Site
      • Miami, Florida, United States, 33015
        • Ironwood Investigational Site
      • Miami, Florida, United States, 33135
        • Ironwood Investigational Site
      • Miami, Florida, United States, 33165
        • Ironwood Investigational Site
      • Miami, Florida, United States, 33175
        • Ironwood Investigational Site
      • Orlando, Florida, United States, 32806
        • Ironwood Investigational Site
      • South Miami, Florida, United States, 33143
        • Ironwood Investigational Site
      • Tampa, Florida, United States, 33634
        • Ironwood Investigational Site
      • West Palm Beach, Florida, United States, 33409
        • Ironwood Investigational Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Ironwood Investigational Site
      • Oakwood, Georgia, United States, 30566
        • Ironwood Investigational Site
      • Sandy Springs, Georgia, United States, 30328
        • Ironwood Investigational Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Ironwood Investigational Site
    • Louisiana
      • Bastrop, Louisiana, United States, 71220
        • Ironwood Investigational Site
      • Metairie, Louisiana, United States, 70006
        • Ironwood Investigational Site
      • Shreveport, Louisiana, United States, 71105
        • Ironwood Investigational Site
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Ironwood Investigational Site
      • Chevy Chase, Maryland, United States, 20815
        • Ironwood Investigational Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Ironwood Investigational Site
      • Watertown, Massachusetts, United States, 02472
        • Ironwood Investigational Site
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Ironwood Investigational Site
      • Wyoming, Michigan, United States, 49519
        • Ironwood Investigational Site
    • Mississippi
      • Jackson, Mississippi, United States, 39202
        • Ironwood Investigational Site
    • Missouri
      • Saint Louis, Missouri, United States, 63128-2197
        • Ironwood Investigational Site
    • Montana
      • Bozeman, Montana, United States, 59718
        • Ironwood Investigational Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Ironwood Investigational Site
      • Las Vegas, Nevada, United States, 89121
        • Ironwood Investigational Site
    • New York
      • Brooklyn, New York, United States, 11206
        • Ironwood Investigational Site
    • North Carolina
      • Charlotte, North Carolina, United States, 28210
        • Ironwood Investigational Site
      • Concord, North Carolina, United States, 28025
        • Ironwood Investigational Site
      • Davidson, North Carolina, United States, 28036
        • Ironwood Investigational Site
      • Fayetteville, North Carolina, United States, 28304
        • Ironwood Investigational Site
      • Wilmington, North Carolina, United States, 28401
        • Ironwood Investigational Site
      • Winston-Salem, North Carolina, United States, 27103
        • Ironwood Investigational Site
    • Ohio
      • Cincinnati, Ohio, United States, 45224
        • Ironwood Investigational Site
      • Cincinnati, Ohio, United States, 45219
        • Ironwood Investigational Site
      • Mentor, Ohio, United States, 44060
        • Ironwood Investigational Site
      • Xenia, Ohio, United States, 45385
        • Ironwood Investigational Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15206
        • Ironwood Investigational Site
    • South Dakota
      • Dakota Dunes, South Dakota, United States, 57049
        • Ironwood Investigational Site
    • Tennessee
      • Bristol, Tennessee, United States, 37620
        • Ironwood Investigational Site
      • Chattanooga, Tennessee, United States, 37421
        • Ironwood Investigational Site
      • Knoxville, Tennessee, United States, 37909
        • Ironwood Investigational Site
    • Texas
      • Arlington, Texas, United States, 76012
        • Ironwood Investigational Site
      • Beaumont, Texas, United States, 77001
        • Ironwood Investigational Site
      • El Paso, Texas, United States, 79905
        • Ironwood Investigational Site
      • Houston, Texas, United States, 77074
        • Ironwood Investigational Site
      • San Antonio, Texas, United States, 78229
        • Ironwood Investigational Site
      • San Antonio, Texas, United States, 78209
        • Ironwood Investigational Site
      • San Antonio, Texas, United States, 78258
        • Ironwood Investigational Site
    • Utah
      • Ogden, Utah, United States, 84405
        • Ironwood Investigational Site
      • Sandy, Utah, United States, 84094
        • Ironwood Investigational Site
    • Virginia
      • Christiansburg, Virginia, United States, 24073
        • Ironwood Investigational Site
      • Lynchburg, Virginia, United States, 24502
        • Ironwood Investigational Site
    • Wisconsin
      • La Crosse, Wisconsin, United States, 54601
        • Ironwood Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Placebo
Drug: Matching Placebo
Oral, once daily
Experimental: 30 μg linaclotide DR1 and placebo
Drug: Linaclotide
Oral, once daily
Experimental: 100 μg linaclotide DR1 and placebo
Drug: Linaclotide
Oral, once daily
Experimental: 300 μg linaclotide DR1 and placebo
Drug: Linaclotide
Oral, once daily
Experimental: 30 μg linaclotide DR2 and placebo
Drug: Linaclotide
Oral, once daily
Experimental: 100 μg linaclotide DR2 and placebo
Drug: Linaclotide
Oral, once daily
Experimental: 300 μg linaclotide DR2 and placebo
Drug: Linaclotide
Oral, once daily
Experimental: 290 μg linaclotide IR and placebo
Drug: Linaclotide
Oral, once daily

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR1 or IR vs. Placebo
Time Frame: Baseline, up to Week 12
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.
Baseline, up to Week 12
Change From Baseline in Weekly Abdominal Pain Score Over the 12-Week Treatment Period: DR2 or IR vs. Placebo
Time Frame: Baseline, up to Week 12
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.
Baseline, up to Week 12
Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR1 or IR vs. Placebo
Time Frame: Baseline, up to Week 12
A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week.
Baseline, up to Week 12
Change From Baseline in Weekly CSBM Frequency Rate Over the 12-Week Treatment Period: DR2 or IR vs. Placebo
Time Frame: Baseline, up to Week 12
A participant's weekly CSBM frequency rate is the CSBM rate (CSBMs/week) calculated over that week.
Baseline, up to Week 12
Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR1 or IR vs. Placebo
Time Frame: up to Week 12

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.
up to Week 12
Number of 6/12 Week Abdominal Pain and Constipation (APC) +1 Responders Over the 12-Week Treatment Period: DR2 or IR vs. Placebo
Time Frame: up to Week 12

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.
up to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ironwood Pharmaceuticals, Inc.

Collaborators

Forest Laboratories

Investigators

  • Study Chair: Paul Chamberlin, MD, Ironwood Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 22, 2015

Primary Completion (Actual)

September 30, 2016

Study Completion (Actual)

September 30, 2016

Study Registration Dates

First Submitted

September 22, 2015

First Submitted That Met QC Criteria

September 22, 2015

First Posted (Estimate)

September 24, 2015

Study Record Updates

Last Update Posted (Actual)

April 24, 2020

Last Update Submitted That Met QC Criteria

April 9, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MCP-103-204

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Irritable Bowel Syndrome With Constipation

Clinical Trials on Linaclotide

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Portugal

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe