The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C) (IBS-C)

June 13, 2019 updated by: Bausch Health Americas, Inc.

A Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.

Screening/Baseline: Patients will undergo an up to 28-day Screening/Baseline period to allow for any necessary diagnostic procedures, allow for required washout of medications and to determine study eligibility. If otherwise eligible based on screening criteria, patients will undergo a 2-week baseline assessment using an electronic diary where they will record daily assessments of bowel movements (BMs), stool consistency (Bristol Stool Form Scale-BSFS), abdominal pain and other IBS-related symptoms. Data from the two-week electronic diary assessment just prior to the randomization visit will be used to confirm IBS-C and study eligibility as well as define the patient's baseline from which change will be determined.

Treatment: Patients who meet all entry criteria will be randomized (1:1:1) to one of three blinded treatment groups on Day 1 of the Treatment period. Patients will take an oral dose of study drug OD for 12 weeks and continue the daily electronic diaries (BMs, rescue medication use, abdominal pain, and other symptoms). During treatment weeks 4, 8, and 12, patients will return to the clinic to undergo safety and efficacy assessments.

Post-Treatment: For 2 weeks after completing dosing, patients will continue to complete daily electronic diaries. Patients will then return to the clinical site for a final follow-up visit during Week 14 following randomization.

The planned duration of participation in this study will be at least 116 days from signing of informed consent through post-treatment or up to approximately 135 days with visit windows considered.

Study Type

Interventional

Enrollment (Actual)

1054

Phase

  • Phase 3

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
      • Athens, Alabama, United States, 35611
        • Synergy Research Site
      • Birmingham, Alabama, United States, 35242
        • Synergy Research Site
      • Dothan, Alabama, United States, 36305
        • Synergy Research Site
      • Foley, Alabama, United States, 36535
        • Synergy Research Site
      • Huntsville, Alabama, United States, 35801
        • Synergy Research Site
      • Montgomery, Alabama, United States, 36106
        • Synergy Research Site
    • Arizona
      • Chandler, Arizona, United States, 85224
        • Synergy Research Site
      • Glendale, Arizona, United States, 85308
        • Synergy Research Site
      • Phoenix, Arizona, United States, 85018
        • Synergy Research Site
      • Tucson, Arizona, United States, 85710
        • Synergy Research Site
      • Tucson, Arizona, United States, 85712
        • Synergy Research Site
    • Arkansas
      • Conway, Arkansas, United States, 72034
        • Synergy Research Site
      • Little Rock, Arkansas, United States, 72211
        • Synergy Research Site
      • Little Rock, Arkansas, United States, 72212
        • Synergy Research Site
    • California
      • Anaheim, California, United States, 92801
        • Synergy Research Site
      • Artesia, California, United States, 90701
        • Synergy Research Site
      • Chula Vista, California, United States, 91910
        • Synergy Research Site
      • Corona, California, United States, 92879
        • Synergy Research Site
      • Encino, California, United States, 91436
        • Synergy Research Site
      • Fountain Valley, California, United States, 92708
        • Synergy Research Site
      • Fresno, California, United States, 93702
        • Synergy Research Site
      • Garden Grove, California, United States, 92840
        • Synergy Research Site
      • La Mesa, California, United States, 91942
        • Synergy Research Site
      • La Mirada, California, United States, 90638
        • Synergy Research Site
      • Laguna Hills, California, United States, 92653
        • Synergy Research Site
      • Lancaster, California, United States, 93534
        • Synergy Research Site
      • North Hollywood, California, United States, 91606
        • Synergy Research Site
      • Sacramento, California, United States, 95821
        • Synergy Research Site
      • San Bernardino, California, United States, 92408
        • Synergy Research Site
      • San Diego, California, United States, 92103
        • Synergy Research Site
      • Thousand Oaks, California, United States, 91360
        • Synergy Research Site
      • Upland, California, United States, 91786
        • Synergy Research Site
      • Upland, California, United States
        • Synergy Research Site
    • Colorado
      • Broomfield, Colorado, United States
        • Synergy Research Site
      • Centennial, Colorado, United States, 80112
        • Synergy Research Site.
    • Connecticut
      • Bristol, Connecticut, United States, 06010
        • Synergy Research Site
      • Hamden, Connecticut, United States, 06518
        • Synergy Research Site
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Synergy Research Site
      • Brandon, Florida, United States, 33511
        • Synergy Research Site
      • DeLand, Florida, United States, 32720
        • Synergy Research Site
      • Fort Lauderdale, Florida, United States, 33308
        • Synergy Research Site
      • Homestead, Florida, United States, 33030
        • Synergy Research Site
      • Inverness, Florida, United States, 34452
        • Synergy Research Site
      • Jacksonville, Florida, United States, 32205
        • Synergy Research Site
      • Miami, Florida, United States, 33144
        • Synergy Research Site
      • Miami Lakes, Florida, United States, 33014
        • Synergy Research Site
      • Miami Springs, Florida, United States, 33166
        • Synergy Research Site
      • Orlando, Florida, United States, 32801
        • Synergy Research Site
      • Ormond Beach, Florida, United States, 32174
        • Synergy Research Site
      • Oviedo, Florida, United States, 32765
        • Synergy Research Site
      • Port Orange, Florida, United States, 32129
        • Synergy Research Site
      • Saint Petersburg, Florida, United States, 33709
        • Synergy Research Site
      • Tampa, Florida, United States, 33607
        • Synergy Research Site
    • Georgia
      • Atlanta, Georgia, United States, 30328
        • Synergy Research Site
      • Marietta, Georgia, United States, 30060
        • Synergy Research Site
      • Norcross, Georgia, United States, 30071
        • Synergy Research Site
      • Norcross, Georgia, United States, 30092
        • Synergy Research Site
      • Stockbridge, Georgia, United States, 30281
        • Synergy Research Site
    • Idaho
      • Idaho Falls, Idaho, United States
        • Synergy Research Site
      • Idaho Falls, Idaho, United States, 83404
        • Synergy Research Site
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Synergy Research Site
      • Evanston, Illinois, United States, 60201
        • Synergy Research Site
      • Evergreen Park, Illinois, United States, 60805
        • Synergy Research Site
      • Rockford, Illinois, United States, 61107
        • Synergy Research Site
    • Indiana
      • Evansville, Indiana, United States, 47714
        • Synergy Research Site
    • Kansas
      • Augusta, Kansas, United States, 67010
        • Synergy Research Site
      • Newton, Kansas, United States, 67114
        • Synergy Research Site
      • Topeka, Kansas, United States, 66606
        • Synergy Research Site
      • Wichita, Kansas, United States, 67205
        • Synergy Research Site
      • Wichita, Kansas, United States, 67207
        • Synergy Research Site
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Synergy Research Site
      • Crowley, Louisiana, United States, 70526
        • Synergy Research Site
      • Mandeville, Louisiana, United States, 70448
        • Synergy Research Site
      • Metairie, Louisiana, United States, 70006
        • Synergy Research Site
      • Monroe, Louisiana, United States, 71201
        • Synergy Research Site
      • New Orleans, Louisiana, United States, 70115
        • Synergy Research Site
      • Shreveport, Louisiana, United States, 71105
        • Synergy Research Site
    • Maryland
      • Baltimore, Maryland, United States, 21215
        • Synergy Research Site
      • Hagerstown, Maryland, United States, 21742
        • Synergy Research Site
    • Massachusetts
      • Boston, Massachusetts, United States, 02131
        • Synergy Research Site
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Synergy Research Site
      • Flint, Michigan, United States, 48504
        • Synergy Research Site
      • Rochester, Michigan, United States, 48307
        • Synergy Research Site
      • Wyoming, Michigan, United States, 49519
        • Synergy Research Site
    • Mississippi
      • Jackson, Mississippi, United States
        • Synergy Research Site.
    • Missouri
      • Hazelwood, Missouri, United States, 63042
        • Synergy Research Site
    • Nebraska
      • Omaha, Nebraska, United States, 68134
        • Synergy Research Site
    • Nevada
      • Las Vegas, Nevada, United States, 89119
        • Synergy Research Site
    • New Jersey
      • Marlton, New Jersey, United States, 08053
        • Synergy Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Synergy Research Site
    • New York
      • Brooklyn, New York, United States, 11206
        • Synergy Research Site
      • Great Neck, New York, United States, 11023
        • Synergy Research Site
      • New Windsor, New York, United States, 12553
        • Synergy Research Site
      • New York, New York, United States, 10016
        • Synergy Research Site
      • North Massapequa, New York, United States, 11758
        • Synergy Research Site
    • North Carolina
      • Asheboro, North Carolina, United States, 27203
        • Synergy Research Site
      • Cary, North Carolina, United States, 27513
        • Synergy Research Site
      • Charlotte, North Carolina, United States, 28210
        • Synergy Research Site
      • Charlotte, North Carolina, United States, 28277
        • Synergy Research Site
      • Concord, North Carolina, United States, 28025
        • Synergy Research Site
      • Davidson, North Carolina, United States, 28036
        • Synergy Research Site
      • Greensboro, North Carolina, United States, 27403
        • Synergy Research Site
      • Kinston, North Carolina, United States, 28501
        • Synergy Research Site
      • Lenoir, North Carolina, United States, 28645
        • Synergy Research Site
      • Raleigh, North Carolina, United States, 27612
        • Synergy Research Site
      • Wilmington, North Carolina, United States, 28401
        • Synergy Research Site
      • Winston-Salem, North Carolina, United States, 27103
        • Synergy Research Site
    • North Dakota
      • Fargo, North Dakota, United States, 58103
        • Synergy Research Site
    • Ohio
      • Beavercreek, Ohio, United States, 45440
        • Synergy Research Site
      • Cincinnati, Ohio, United States, 45212
        • Synergy Research Site
      • Cleveland, Ohio, United States, 44122
        • Synergy Research Site
      • Cleveland, Ohio, United States
        • Synergy Research Site
      • Englewood, Ohio, United States, 45322
        • Synergy Research Site
      • Sylvania, Ohio, United States, 43560
        • Synergy Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73102
        • Synergy Research Site
      • Tulsa, Oklahoma, United States, 74135
        • Synergy Research Site
    • Oregon
      • Portland, Oregon, United States, 97210
        • Synergy Research Site
    • Pennsylvania
      • Levittown, Pennsylvania, United States, 19056
        • Synergy Research Site
      • Philadelphia, Pennsylvania, United States, 19152
        • Synergy Research Site
      • Pittsburgh, Pennsylvania, United States, 15206
        • Synergy Research Site
      • Smithfield, Pennsylvania, United States, 15478
        • Synergy Research Site
      • Uniontown, Pennsylvania, United States, 15401
        • Synergy Research Site
    • South Carolina
      • Columbia, South Carolina, United States, 29204
        • Synergy Research Site
      • Gaffney, South Carolina, United States, 29341
        • Synergy Research Site
      • Greer, South Carolina, United States, 29650
        • Synergy Research Site.
      • North Charleston, South Carolina, United States, 29406
        • Synergy Research Site
    • South Dakota
      • Rapid City, South Dakota, United States, 57702
        • Synergy Research Site
    • Tennessee
      • Athens, Tennessee, United States, 37303
        • Synergy Research Site
      • Chattanooga, Tennessee, United States, 37404
        • Synergy Research Site
      • Memphis, Tennessee, United States, 38119
        • Synergy Research Site
      • Nashville, Tennessee, United States, 37211
        • Synergy Research Site.
    • Texas
      • Arlington, Texas, United States
        • Synergy Research Site
      • Austin, Texas, United States, 78758
        • Synergy Research Site
      • Austin, Texas, United States, 78756
        • Synergy Research Site
      • Carrollton, Texas, United States, 75010
        • Synergy Research Site
      • Dallas, Texas, United States, 75230
        • Synergy Research Site
      • Houston, Texas, United States, 77099
        • Synergy Research Site
      • Houston, Texas, United States, 77074
        • Synergy Research Site
      • Plano, Texas, United States, 75093
        • Synergy Research Site
      • San Antonio, Texas, United States, 78229
        • Synergy Research Site
      • Webster, Texas, United States, 77598
        • Synergy Research Site
    • Utah
      • Bountiful, Utah, United States, 84010
        • Synergy Research Site
      • Ogden, Utah, United States, 84405
        • Synergy Research Site
      • Saint George, Utah, United States, 84790
        • Synergy Research Site
      • Sandy, Utah, United States, 84092
        • Synergy Research Site
    • Virginia
      • Alexandria, Virginia, United States, 22304
        • Synergy Research Site
      • Charlottesville, Virginia, United States, 22911
        • Synergy Research Site
      • Lynchburg, Virginia, United States, 24502
        • Synergy Research Site
      • Newport News, Virginia, United States, 23606
        • Synergy Research Site
    • Washington
      • Bellevue, Washington, United States, 98004
        • Synergy Research Site
      • Spokane, Washington, United States, 99208
        • Synergy Research Site
    • West Virginia
      • Charleston, West Virginia, United States, 25304
        • Synergy Research Site
      • Morgantown, West Virginia, United States, 26505
        • Synergy Research Site
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53215
        • Synergy Research Site
      • Wauwatosa, Wisconsin, United States, 53226
        • Synergy Research 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 to 85 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

•Adult patients between the ages of 18 and 85 years (inclusive) with a diagnosis of IBS based on ROME III diagnostic criteria and meeting criteria for diagnosis of the constipation predominant subtype - IBS-C

Exclusion Criteria:

  • Refusal or inability to sign informed consent for the trial
  • Refusal or inability to complete daily Episodic (real-time) BM / RM calls, End of Day daily Calls, and/or complete electronic questionnaires
  • BMI > 35 or < 18
  • Women of child bearing potential who refuse to use an acceptable method of birth control for the duration of the trial
  • Women who are pregnant or lactating
  • Diagnosis of IBS-D or IBS-M
  • Organic or obstructive disease of the small or large intestine
  • Use of laxatives other than the study-supplied rescue medication (Dulcolax®, bisacodyl)
  • Use of a prohibited concomitant medication within the time frame prior to screening outlined in the study protocol for that medication
  • Unstable medical illness
  • Bilirubin > 3X ULN in the absence of a conjugation defect
  • Any laboratory value > 3X ULN unless discussed and approved by the study Medical Monitor

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
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: 3.0 mg plecanatide
Plecanatide 3.0 mg dosed daily for 12 weeks
Drug: Plecanatide
ACTIVE_COMPARATOR: 6.0 mg plecanatide
Plecanatide 6.0 mg dosed daily for 12 weeks
Drug: Plecanatide
ACTIVE_COMPARATOR: Matching placebo
Placebo dosed daily for 12 weeks
Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Overall Responders - ITT Population
Time Frame: 12 Weeks
An Overall Responder was a patient who was a Weekly Responder (i.e., decrease of 30% from baseline for abdominal pain intensity and an increase of at least one complete spontaneous bowel movement in the same week) for at least 6 of the 12 treatment weeks.
12 Weeks
Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks
Time Frame: 12 Weeks
An Abdominal Pain Intensity Responder was a patient who had a decrease of 30% from baseline for abdominal pain intensity. Baseline was the mean of non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.
12 Weeks
Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks
Time Frame: 12 weeks
A Stool Frequency Responder is defined as a patient who experienced an increase of at least one CSBM (complete spontaneous bowel movement) per week from baseline. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.
12 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Sustained Efficacy Responders
Time Frame: 12 weeks
A Sustained Efficacy Responder was a patient who was an Overall Responder who also was a Weekly Responder, i.e., decreased of 30% from baseline for abdominal pain intensity and increased of at least one CSBM (complete spontaneous bowel movement) in the same week for at least 2 of the 4 weeks in month 3 of the Treatment Period.
12 weeks
Change From Baseline in Stool Consistency
Time Frame: Baseline and 12-Week

Change from baseline in stool consistency based upon the Bristol Stool Form Scale (BSFS) Rating 1 to 7. Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. BSFS Rating 1 to 7:

  1. Separate hard lumps, like nuts (hard to pass)
  2. Sausage-shaped but lumpy
  3. Like a sausage but with cracks on its surface
  4. Like a sausage or snake, smooth and soft
  5. Soft blobs with clear-cut edges (passed easily)
  6. Fluffy pieces with ragged edges, a mushy stool
  7. Watery, no solid pieces, entirely liquid
Baseline and 12-Week
Change From Baseline in Straining
Time Frame: Baseline and 12-week
Change from baseline in Straining Score over the 12-week treatment period. Baseline was the mean of non-missing straining scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The severity of straining during a bowel movement was measured using an 11-point scale (0-10 rating; 0 = no straining; 10 = worst straining).
Baseline and 12-week
Change From Baseline in CSBM Frequency Rate
Time Frame: Baseline and 12-Week
Change from baseline over the 12-week Treatment Period in CSBM (Complete Spontaneous Bowel Movement) Frequency Rate (CSBMs/Week). Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.
Baseline and 12-Week
Number of Patients With a SBM Within 24 Hours After the First Dose
Time Frame: Up to 24 hours after first dose of study drug
Number of patients with a SBM (spontaneous bowel movement) within 24 hours after the first dose of study drug
Up to 24 hours after first dose of study drug
Change From Baseline in Abdominal Pain
Time Frame: Baseline and 12-Week
Change from baseline in abdominal pain as measured with an 11-point (0-10) Numerical Rating Scale from 0 (No) to 10 (Worst Possible). Baseline is the mean of non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.
Baseline and 12-Week

Collaborators and Investigators

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

Sponsor

Bausch Health Americas, 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

December 1, 2014

Primary Completion (ACTUAL)

December 1, 2016

Study Completion (ACTUAL)

February 1, 2017

Study Registration Dates

First Submitted

January 20, 2015

First Submitted That Met QC Criteria

March 6, 2015

First Posted (ESTIMATE)

March 13, 2015

Study Record Updates

Last Update Posted (ACTUAL)

June 14, 2019

Last Update Submitted That Met QC Criteria

June 13, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP304203-04

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.

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