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

Last updated: June 13, 2019
Sponsor: Bausch Health Americas, Inc.
Overall Status: Completed

Phase

3

Condition

Constipation

Colic

Gastrointestinal Diseases And Disorders

Treatment

N/A

Clinical Study ID

NCT02387359
SP304203-04
  • Ages 18-85
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

Exclusion

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 Daydaily Calls, and/or complete electronic questionnaires

  • BMI > 35 or < 18

  • Women of child bearing potential who refuse to use an acceptable method of birthcontrol 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 screeningoutlined 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 MedicalMonitor

Study Design

Total Participants: 1054
Study Start date:
December 01, 2014
Estimated Completion Date:
February 28, 2017

Study 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.

Connect with a study center

  • Synergy Research Site

    Athens, Alabama 35611
    United States

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  • Synergy Research Site

    Birmingham, Alabama 35242
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    Dothan, Alabama 36305
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    Foley, Alabama 36535
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    Huntsville, Alabama 35801
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    Montgomery, Alabama 36106
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    Chandler, Arizona 85224
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    Glendale, Arizona 85308
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    Phoenix, Arizona 85018
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    Tucson, Arizona 85712
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    Conway, Arkansas 72034
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    Little Rock, Arkansas 72212
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    Anaheim, California 92801
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    Artesia, California 90701
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    Chula Vista, California 91910
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    Corona, California 92879
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    Encino, California 91436
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    Laguna Hills, California 92653
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    Lancaster, California 93534
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    North Hollywood, California 91606
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    San Bernardino, California 92408
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    San Diego, California 92103
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    Centennial, Colorado 80112
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    Boynton Beach, Florida 33426
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    Chicago, Illinois 60611
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    Rockford, Illinois 61107
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    Evansville, Indiana 47714
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    NY, New York 10170
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    Greensboro, North Carolina 27403
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    Kinston, North Carolina 28501
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    Lenoir, North Carolina 28645
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    Raleigh, North Carolina 27612
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    Wilmington, North Carolina 28401
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    Winston-Salem, North Carolina 27103
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    Beavercreek, Ohio 45440
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    Englewood, Ohio 45322
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    Sylvania, Ohio 43560
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    Oklahoma City, Oklahoma 73102
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    Greer, South Carolina 29650
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    Chattanooga, Tennessee 37404
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    Memphis, Tennessee 38119
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    Nashville, Tennessee 37211
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    Arlington, Texas
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    Austin, Texas 78758
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    Carrollton, Texas 75010
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  • Synergy Pharmaceuticals Inc.

    Carrolton, Texas
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    Dallas, Texas 75230
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    Plano, Texas 75093
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    San Antonio, Texas 78229
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    Bountiful, Utah 84010
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  • Synergy Pharmaceuticals Inc.

    George, Utah
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    Ogden, Utah 84405
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    Saint George, Utah 84790
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    Sandy, Utah 84092
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    Alexandria, Virginia 22304
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    Charlottesville, Virginia 22911
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    Lynchburg, Virginia 24502
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    Newport News, Virginia 23606
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    Bellevue, Washington 98004
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    Spokane, Washington 99208
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    Charleston, West Virginia 25304
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    Morgantown, West Virginia 26505
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    Milwaukee, Wisconsin 53215
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  • Synergy Research Site

    Wauwatosa, Wisconsin 53226
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