--- title: The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C) nct_id: NCT02387359 overall_status: COMPLETED phase: PHASE3 sponsor: Bausch Health Americas, Inc. study_type: INTERVENTIONAL primary_condition: Irritable Bowel Syndrome Characterized by Constipation countries: United States canonical_url: "https://parkinsonspathways.com/agent/trials/NCT02387359.md" clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT02387359" ct_last_update_post_date: 2019-06-14 last_seen_at: "2026-05-12T06:58:31.085Z" source: ClinicalTrials.gov (mirrored, no enrichment) --- # The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C) **Official Title:** 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) **NCT ID:** [NCT02387359](https://clinicaltrials.gov/study/NCT02387359) ## Key Facts - **Status:** COMPLETED - **Phase:** PHASE3 - **Study Type:** INTERVENTIONAL - **Target Enrollment:** 1054 - **Lead Sponsor:** Bausch Health Americas, Inc. - **Conditions:** Irritable Bowel Syndrome Characterized by Constipation - **Start Date:** 2014-12 - **Completion Date:** 2017-02 - **CT.gov Last Update:** 2019-06-14 ## Brief 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. ## 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. ## Eligibility - **Minimum age:** 18 Years - **Maximum age:** 85 Years - **Sex:** ALL - **Healthy Volunteers:** No ``` 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 ``` ## Arms - **3.0 mg plecanatide** (ACTIVE_COMPARATOR) — Plecanatide 3.0 mg dosed daily for 12 weeks - **6.0 mg plecanatide** (ACTIVE_COMPARATOR) — Plecanatide 6.0 mg dosed daily for 12 weeks - **Matching placebo** (ACTIVE_COMPARATOR) — Placebo dosed daily for 12 weeks ## Interventions - **Plecanatide** (DRUG) - **Placebo** (DRUG) ## Primary Outcomes - **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. - **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. - **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. ## Secondary Outcomes - **Number of Sustained Efficacy Responders** _(time frame: 12 weeks)_ - **Change From Baseline in Stool Consistency** _(time frame: Baseline and 12-Week)_ - **Change From Baseline in Straining** _(time frame: Baseline and 12-week)_ - **Change From Baseline in CSBM Frequency Rate** _(time frame: 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)_ - **Change From Baseline in Abdominal Pain** _(time frame: Baseline and 12-Week)_ ## Locations (155) - Synergy Research Site, Athens, Alabama, United States - Synergy Research Site, Birmingham, Alabama, United States - Synergy Research Site, Dothan, Alabama, United States - Synergy Research Site, Foley, Alabama, United States - Synergy Research Site, Huntsville, Alabama, United States - Synergy Research Site, Montgomery, Alabama, United States - Synergy Research Site, Chandler, Arizona, United States - Synergy Research Site, Glendale, Arizona, United States - Synergy Research Site, Phoenix, Arizona, United States - Synergy Research Site, Tucson, Arizona, United States - Synergy Research Site, Tucson, Arizona, United States - Synergy Research Site, Conway, Arkansas, United States - Synergy Research Site, Little Rock, Arkansas, United States - Synergy Research Site, Little Rock, Arkansas, United States - Synergy Research Site, Anaheim, California, United States - Synergy Research Site, Artesia, California, United States - Synergy Research Site, Chula Vista, California, United States - Synergy Research Site, Corona, California, United States - Synergy Research Site, Encino, California, United States - Synergy Research Site, Fountain Valley, California, United States - Synergy Research Site, Fresno, California, United States - Synergy Research Site, Garden Grove, California, United States - Synergy Research Site, La Mesa, California, United States - Synergy Research Site, La Mirada, California, United States - Synergy Research Site, Laguna Hills, California, United States - Synergy Research Site, Lancaster, California, United States - Synergy Research Site, North Hollywood, California, United States - Synergy Research Site, Sacramento, California, United States - Synergy Research Site, San Bernardino, California, United States - Synergy Research Site, San Diego, California, United States - Synergy Research Site, Thousand Oaks, California, United States - Synergy Research Site, Upland, California, United States - Synergy Research Site, Upland, California, United States - Synergy Research Site, Broomfield, Colorado, United States - Synergy Research Site., Centennial, Colorado, United States - Synergy Research Site, Bristol, Connecticut, United States - Synergy Research Site, Hamden, Connecticut, United States - Synergy Research Site, Boynton Beach, Florida, United States - Synergy Research Site, Brandon, Florida, United States - Synergy Research Site, DeLand, Florida, United States - Synergy Research Site, Fort Lauderdale, Florida, United States - Synergy Research Site, Homestead, Florida, United States - Synergy Research Site, Inverness, Florida, United States - Synergy Research Site, Jacksonville, Florida, United States - Synergy Research Site, Miami, Florida, United States - Synergy Research Site, Miami Lakes, Florida, United States - Synergy Research Site, Miami Springs, Florida, United States - Synergy Research Site, Orlando, Florida, United States - Synergy Research Site, Ormond Beach, Florida, United States - Synergy Research Site, Oviedo, Florida, United States - Synergy Research Site, Port Orange, Florida, United States - Synergy Research Site, St. Petersburg, Florida, United States - Synergy Research Site, Tampa, Florida, United States - Synergy Research Site, Atlanta, Georgia, United States - Synergy Research Site, Marietta, Georgia, United States - Synergy Research Site, Norcross, Georgia, United States - Synergy Research Site, Norcross, Georgia, United States - Synergy Research Site, Stockbridge, Georgia, United States - Synergy Research Site, Idaho Falls, Idaho, United States - Synergy Research Site, Idaho Falls, Idaho, United States - Synergy Research Site, Chicago, Illinois, United States - Synergy Research Site, Evanston, Illinois, United States - Synergy Research Site, Evergreen Park, Illinois, United States - Synergy Research Site, Rockford, Illinois, United States - Synergy Research Site, Evansville, Indiana, United States - Synergy Research Site, Augusta, Kansas, United States - Synergy Research Site, Newton, Kansas, United States - Synergy Research Site, Topeka, Kansas, United States - Synergy Research Site, Wichita, Kansas, United States - Synergy Research Site, Wichita, Kansas, United States - Synergy Research Site, Baton Rouge, Louisiana, United States - Synergy Research Site, Crowley, Louisiana, United States - Synergy Research Site, Mandeville, Louisiana, United States - Synergy Research Site, Metairie, Louisiana, United States - Synergy Research Site, Monroe, Louisiana, United States - Synergy Research Site, New Orleans, Louisiana, United States - Synergy Research Site, Shreveport, Louisiana, United States - Synergy Research Site, Baltimore, Maryland, United States - Synergy Research Site, Hagerstown, Maryland, United States - Synergy Research Site, Boston, Massachusetts, United States - Synergy Research Site, Chesterfield, Michigan, United States - Synergy Research Site, Flint, Michigan, United States - Synergy Research Site, Rochester, Michigan, United States - Synergy Research Site, Wyoming, Michigan, United States - Synergy Research Site., Jackson, Mississippi, United States - Synergy Research Site, Hazelwood, Missouri, United States - Synergy Research Site, Omaha, Nebraska, United States - Synergy Research Site, Las Vegas, Nevada, United States - Synergy Research Site, Marlton, New Jersey, United States - Synergy Research Site, Albuquerque, New Mexico, United States - Synergy Research Site, Brooklyn, New York, United States - Synergy Research Site, Great Neck, New York, United States - Synergy Research Site, New Windsor, New York, United States - Synergy Research Site, New York, New York, United States - Synergy Research Site, North Massapequa, New York, United States - Synergy Research Site, Asheboro, North Carolina, United States - Synergy Research Site, Cary, North Carolina, United States - Synergy Research Site, Charlotte, North Carolina, United States - Synergy Research Site, Charlotte, North Carolina, United States - Synergy Research Site, Concord, North Carolina, United States - Synergy Research Site, Davidson, North Carolina, United States - Synergy Research Site, Greensboro, North Carolina, United States - Synergy Research Site, Kinston, North Carolina, United States - Synergy Research Site, Lenoir, North Carolina, United States - Synergy Research Site, Raleigh, North Carolina, United States - Synergy Research Site, Wilmington, North Carolina, United States - Synergy Research Site, Winston-Salem, North Carolina, United States - Synergy Research Site, Fargo, North Dakota, United States - Synergy Research Site, Beavercreek, Ohio, United States - Synergy Research Site, Cincinnati, Ohio, United States - Synergy Research Site, Cleveland, Ohio, United States - Synergy Research Site, Cleveland, Ohio, United States - Synergy Research Site, Englewood, Ohio, United States - Synergy Research Site, Sylvania, Ohio, United States - Synergy Research Site, Oklahoma City, Oklahoma, United States - Synergy Research Site, Tulsa, Oklahoma, United States - Synergy Research Site, Portland, Oregon, United States - Synergy Research Site, Levittown, Pennsylvania, United States - Synergy Research Site, Philadelphia, Pennsylvania, United States - Synergy Research Site, Pittsburgh, Pennsylvania, United States - Synergy Research Site, Smithfield, Pennsylvania, United States - Synergy Research Site, Uniontown, Pennsylvania, United States - Synergy Research Site, Columbia, South Carolina, United States - Synergy Research Site, Gaffney, South Carolina, United States - Synergy Research Site., Greer, South Carolina, United States - Synergy Research Site, North Charleston, South Carolina, United States - Synergy Research Site, Rapid City, South Dakota, United States - Synergy Research Site, Athens, Tennessee, United States - Synergy Research Site, Chattanooga, Tennessee, United States - Synergy Research Site, Memphis, Tennessee, United States - Synergy Research Site., Nashville, Tennessee, United States - Synergy Research Site, Arlington, Texas, United States - Synergy Research Site, Austin, Texas, United States - Synergy Research Site, Austin, Texas, United States - Synergy Research Site, Carrollton, Texas, United States - Synergy Research Site, Dallas, Texas, United States - Synergy Research Site, Houston, Texas, United States - Synergy Research Site, Houston, Texas, United States - Synergy Research Site, Plano, Texas, United States - Synergy Research Site, San Antonio, Texas, United States - Synergy Research Site, Webster, Texas, United States - Synergy Research Site, Bountiful, Utah, United States - Synergy Research Site, Ogden, Utah, United States - Synergy Research Site, Sandy City, Utah, United States - Synergy Research Site, St. George, Utah, United States - Synergy Research Site, Alexandria, Virginia, United States - Synergy Research Site, Charlottesville, Virginia, United States - Synergy Research Site, Lynchburg, Virginia, United States - Synergy Research Site, Newport News, Virginia, United States - Synergy Research Site, Bellevue, Washington, United States - Synergy Research Site, Spokane, Washington, United States - Synergy Research Site, Charleston, West Virginia, United States - Synergy Research Site, Morgantown, West Virginia, United States - Synergy Research Site, Milwaukee, Wisconsin, United States - Synergy Research Site, Wauwatosa, Wisconsin, United States ## Recent Field Changes (last 30 days) - `status.overallStatus` — added _(2026-05-12)_ - `status.primaryCompletionDate` — added _(2026-05-12)_ - `status.completionDate` — added _(2026-05-12)_ - `status.lastUpdatePostDate` — added _(2026-05-12)_ - `design.phases` — added _(2026-05-12)_ - `design.enrollmentCount` — added _(2026-05-12)_ - `eligibility.criteria` — added _(2026-05-12)_ - `eligibility.minAge` — added _(2026-05-12)_ - `eligibility.maxAge` — added _(2026-05-12)_ - `eligibility.sex` — added _(2026-05-12)_ - `outcomes.primary` — added _(2026-05-12)_ - `outcomes.secondary` — added _(2026-05-12)_ - `armsInterventions.arms` — added _(2026-05-12)_ - `armsInterventions.interventions` — added _(2026-05-12)_ - `sponsor.lead` — added _(2026-05-12)_ - `results.hasResults` — added _(2026-05-12)_ - `locations.synergy research site|athens|alabama|united states` — added _(2026-05-12)_ - `locations.synergy research site|birmingham|alabama|united states` — added _(2026-05-12)_ - `locations.synergy research site|dothan|alabama|united states` — added _(2026-05-12)_ - `locations.synergy research site|foley|alabama|united states` — added _(2026-05-12)_ - `locations.synergy research site|huntsville|alabama|united states` — added _(2026-05-12)_ - `locations.synergy research site|montgomery|alabama|united states` — added _(2026-05-12)_ - `locations.synergy research site|chandler|arizona|united states` — added _(2026-05-12)_ - `locations.synergy research site|glendale|arizona|united states` — added _(2026-05-12)_ - `locations.synergy research site|phoenix|arizona|united states` — added _(2026-05-12)_ - `locations.synergy research site|tucson|arizona|united states` — added _(2026-05-12)_ - `locations.synergy research site|conway|arkansas|united states` — added _(2026-05-12)_ - `locations.synergy research site|little rock|arkansas|united states` — added _(2026-05-12)_ - `locations.synergy research site|anaheim|california|united states` — added _(2026-05-12)_ - `locations.synergy research site|artesia|california|united states` — added _(2026-05-12)_ - `locations.synergy research site|chula vista|california|united states` — added _(2026-05-12)_ - `locations.synergy research site|corona|california|united states` — added _(2026-05-12)_ - `locations.synergy research site|encino|california|united states` — added _(2026-05-12)_ - `locations.synergy research site|fountain valley|california|united states` — added _(2026-05-12)_ - `locations.synergy research site|fresno|california|united states` — added _(2026-05-12)_ - `locations.synergy research site|garden grove|california|united states` — added _(2026-05-12)_ - `locations.synergy research site|la mesa|california|united states` — added _(2026-05-12)_ - `locations.synergy research site|la mirada|california|united states` — added _(2026-05-12)_ - `locations.synergy research site|laguna hills|california|united states` — added _(2026-05-12)_ - `locations.synergy research site|lancaster|california|united states` — added _(2026-05-12)_ - `locations.synergy research site|north hollywood|california|united states` — added _(2026-05-12)_ - `locations.synergy research site|sacramento|california|united states` — added _(2026-05-12)_ - `locations.synergy research site|san bernardino|california|united states` — added _(2026-05-12)_ - `locations.synergy research site|san diego|california|united states` — added _(2026-05-12)_ - `locations.synergy research site|thousand oaks|california|united states` — added _(2026-05-12)_ - `locations.synergy research site|upland|california|united states` — added _(2026-05-12)_ - `locations.synergy research site|broomfield|colorado|united states` — added _(2026-05-12)_ - `locations.synergy research site.|centennial|colorado|united states` — added _(2026-05-12)_ - `locations.synergy research site|bristol|connecticut|united states` — added _(2026-05-12)_ - `locations.synergy research site|hamden|connecticut|united states` — added _(2026-05-12)_ --- *Canonical: https://parkinsonspathways.com/agent/trials/NCT02387359.md* *Source data (authoritative): https://clinicaltrials.gov/study/NCT02387359* *This page is a raw mirror with no AI summary, no editorial enrichment, and no Parkinson's-specific filtering.*