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

NCT02387359 | Completed Phase 3 Results

• 1 other identifier: SP304203-04
• Study Type: interventional
• Target: 1,054
• Locations: 1 country
• Sites: 155

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.

Conditions

Irritable Bowel Syndrome Characterized by Constipation

Outcome Measures

Primary Outcomes (3)

• Number of Overall Responders - ITT Population

  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

  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

  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 Outcomes (6)

• Number of Sustained Efficacy Responders

  12 weeks

• Change From Baseline in Stool Consistency

  Baseline and 12-Week

• Change From Baseline in Straining

  Baseline and 12-week

• Change From Baseline in CSBM Frequency Rate

  Baseline and 12-Week

• Number of Patients With a SBM Within 24 Hours After the First Dose

  Up to 24 hours after first dose of study drug

Study Arms (3)

3.0 mg plecanatide

ACTIVE COMPARATOR

Plecanatide 3.0 mg dosed daily for 12 weeks

Drug: Plecanatide

6.0 mg plecanatide

ACTIVE COMPARATOR

Plecanatide 6.0 mg dosed daily for 12 weeks

Drug: Plecanatide

Matching placebo

ACTIVE COMPARATOR

Placebo dosed daily for 12 weeks

Drug: Placebo

Interventions

Plecanatide DRUG

3.0 mg plecanatide; 6.0 mg plecanatide

Placebo DRUG

Matching placebo

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (155)

Synergy Research Site

Athens, Alabama, 35611, United States

Location

Synergy Research Site

Birmingham, Alabama, 35242, United States

Location

Synergy Research Site

Dothan, Alabama, 36305, United States

Location

Synergy Research Site

Foley, Alabama, 36535, United States

Location

Synergy Research Site

Huntsville, Alabama, 35801, United States

Location

Synergy Research Site

Montgomery, Alabama, 36106, United States

Location

Synergy Research Site

Chandler, Arizona, 85224, United States

Location

Synergy Research Site

Glendale, Arizona, 85308, United States

Location

Synergy Research Site

Phoenix, Arizona, 85018, United States

Location

Synergy Research Site

Tucson, Arizona, 85710, United States

Location

Synergy Research Site

Tucson, Arizona, 85712, United States

Location

Synergy Research Site

Conway, Arkansas, 72034, United States

Location

Synergy Research Site

Little Rock, Arkansas, 72211, United States

Location

Synergy Research Site

Little Rock, Arkansas, 72212, United States

Location

Synergy Research Site

Anaheim, California, 92801, United States

Location

Synergy Research Site

Artesia, California, 90701, United States

Location

Synergy Research Site

Chula Vista, California, 91910, United States

Location

Synergy Research Site

Corona, California, 92879, United States

Location

Synergy Research Site

Encino, California, 91436, United States

Location

Synergy Research Site

Fountain Valley, California, 92708, United States

Location

Synergy Research Site

Fresno, California, 93702, United States

Location

Synergy Research Site

Garden Grove, California, 92840, United States

Location

Synergy Research Site

La Mesa, California, 91942, United States

Location

Synergy Research Site

La Mirada, California, 90638, United States

Location

Synergy Research Site

Laguna Hills, California, 92653, United States

Location

Synergy Research Site

Lancaster, California, 93534, United States

Location

Synergy Research Site

North Hollywood, California, 91606, United States

Location

Synergy Research Site

Sacramento, California, 95821, United States

Location

Synergy Research Site

San Bernardino, California, 92408, United States

Location

Synergy Research Site

San Diego, California, 92103, United States

Location

Synergy Research Site

Thousand Oaks, California, 91360, United States

Location

Synergy Research Site

Upland, California, 91786, United States

Location

Synergy Research Site

Upland, California, United States

Location

Synergy Research Site

Broomfield, Colorado, United States

Location

Synergy Research Site.

Centennial, Colorado, 80112, United States

Location

Synergy Research Site

Bristol, Connecticut, 06010, United States

Location

Synergy Research Site

Hamden, Connecticut, 06518, United States

Location

Synergy Research Site

Boynton Beach, Florida, 33426, United States

Location

Synergy Research Site

Brandon, Florida, 33511, United States

Location

Synergy Research Site

DeLand, Florida, 32720, United States

Location

Synergy Research Site

Fort Lauderdale, Florida, 33308, United States

Location

Synergy Research Site

Homestead, Florida, 33030, United States

Location

Synergy Research Site

Inverness, Florida, 34452, United States

Location

Synergy Research Site

Jacksonville, Florida, 32205, United States

Location

Synergy Research Site

Miami, Florida, 33144, United States

Location

Synergy Research Site

Miami Lakes, Florida, 33014, United States

Location

Synergy Research Site

Miami Springs, Florida, 33166, United States

Location

Synergy Research Site

Orlando, Florida, 32801, United States

Location

Synergy Research Site

Ormond Beach, Florida, 32174, United States

Location

Synergy Research Site

Oviedo, Florida, 32765, United States

Location

Synergy Research Site

Port Orange, Florida, 32129, United States

Location

Synergy Research Site

St. Petersburg, Florida, 33709, United States

Location

Synergy Research Site

Tampa, Florida, 33607, United States

Location

Synergy Research Site

Atlanta, Georgia, 30328, United States

Location

Synergy Research Site

Marietta, Georgia, 30060, United States

Location

Synergy Research Site

Norcross, Georgia, 30071, United States

Location

Synergy Research Site

Norcross, Georgia, 30092, United States

Location

Synergy Research Site

Stockbridge, Georgia, 30281, United States

Location

Synergy Research Site

Idaho Falls, Idaho, 83404, United States

Location

Synergy Research Site

Idaho Falls, Idaho, United States

Location

Synergy Research Site

Chicago, Illinois, 60611, United States

Location

Synergy Research Site

Evanston, Illinois, 60201, United States

Location

Synergy Research Site

Evergreen Park, Illinois, 60805, United States

Location

Synergy Research Site

Rockford, Illinois, 61107, United States

Location

Synergy Research Site

Evansville, Indiana, 47714, United States

Location

Synergy Research Site

Augusta, Kansas, 67010, United States

Location

Synergy Research Site

Newton, Kansas, 67114, United States

Location

Synergy Research Site

Topeka, Kansas, 66606, United States

Location

Synergy Research Site

Wichita, Kansas, 67205, United States

Location

Synergy Research Site

Wichita, Kansas, 67207, United States

Location

Synergy Research Site

Baton Rouge, Louisiana, 70809, United States

Location

Synergy Research Site

Crowley, Louisiana, 70526, United States

Location

Synergy Research Site

Mandeville, Louisiana, 70448, United States

Location

Synergy Research Site

Metairie, Louisiana, 70006, United States

Location

Synergy Research Site

Monroe, Louisiana, 71201, United States

Location

Synergy Research Site

New Orleans, Louisiana, 70115, United States

Location

Synergy Research Site

Shreveport, Louisiana, 71105, United States

Location

Synergy Research Site

Baltimore, Maryland, 21215, United States

Location

Synergy Research Site

Hagerstown, Maryland, 21742, United States

Location

Synergy Research Site

Boston, Massachusetts, 02131, United States

Location

Synergy Research Site

Chesterfield, Michigan, 48047, United States

Location

Synergy Research Site

Flint, Michigan, 48504, United States

Location

Synergy Research Site

Rochester, Michigan, 48307, United States

Location

Synergy Research Site

Wyoming, Michigan, 49519, United States

Location

Synergy Research Site.

Jackson, Mississippi, United States

Location

Synergy Research Site

Hazelwood, Missouri, 63042, United States

Location

Synergy Research Site

Omaha, Nebraska, 68134, United States

Location

Synergy Research Site

Las Vegas, Nevada, 89119, United States

Location

Synergy Research Site

Marlton, New Jersey, 08053, United States

Location

Synergy Research Site

Albuquerque, New Mexico, 87108, United States

Location

Synergy Research Site

Brooklyn, New York, 11206, United States

Location

Synergy Research Site

Great Neck, New York, 11023, United States

Location

Synergy Research Site

New Windsor, New York, 12553, United States

Location

Synergy Research Site

New York, New York, 10016, United States

Location

Synergy Research Site

North Massapequa, New York, 11758, United States

Location

Synergy Research Site

Asheboro, North Carolina, 27203, United States

Location

Synergy Research Site

Cary, North Carolina, 27513, United States

Location

Synergy Research Site

Charlotte, North Carolina, 28210, United States

Location

Synergy Research Site

Charlotte, North Carolina, 28277, United States

Location

Synergy Research Site

Concord, North Carolina, 28025, United States

Location

Synergy Research Site

Davidson, North Carolina, 28036, United States

Location

Synergy Research Site

Greensboro, North Carolina, 27403, United States

Location

Synergy Research Site

Kinston, North Carolina, 28501, United States

Location

Synergy Research Site

Lenoir, North Carolina, 28645, United States

Location

Synergy Research Site

Raleigh, North Carolina, 27612, United States

Location

Synergy Research Site

Wilmington, North Carolina, 28401, United States

Location

Synergy Research Site

Winston-Salem, North Carolina, 27103, United States

Location

Synergy Research Site

Fargo, North Dakota, 58103, United States

Location

Synergy Research Site

Beavercreek, Ohio, 45440, United States

Location

Synergy Research Site

Cincinnati, Ohio, 45212, United States

Location

Synergy Research Site

Cleveland, Ohio, 44122, United States

Location

Synergy Research Site

Cleveland, Ohio, United States

Location

Synergy Research Site

Englewood, Ohio, 45322, United States

Location

Synergy Research Site

Sylvania, Ohio, 43560, United States

Location

Synergy Research Site

Oklahoma City, Oklahoma, 73102, United States

Location

Synergy Research Site

Tulsa, Oklahoma, 74135, United States

Location

Synergy Research Site

Portland, Oregon, 97210, United States

Location

Synergy Research Site

Levittown, Pennsylvania, 19056, United States

Location

Synergy Research Site

Philadelphia, Pennsylvania, 19152, United States

Location

Synergy Research Site

Pittsburgh, Pennsylvania, 15206, United States

Location

Synergy Research Site

Smithfield, Pennsylvania, 15478, United States

Location

Synergy Research Site

Uniontown, Pennsylvania, 15401, United States

Location

Synergy Research Site

Columbia, South Carolina, 29204, United States

Location

Synergy Research Site

Gaffney, South Carolina, 29341, United States

Location

Synergy Research Site.

Greer, South Carolina, 29650, United States

Location

Synergy Research Site

North Charleston, South Carolina, 29406, United States

Location

Synergy Research Site

Rapid City, South Dakota, 57702, United States

Location

Synergy Research Site

Athens, Tennessee, 37303, United States

Location

Synergy Research Site

Chattanooga, Tennessee, 37404, United States

Location

Synergy Research Site

Memphis, Tennessee, 38119, United States

Location

Synergy Research Site.

Nashville, Tennessee, 37211, United States

Location

Synergy Research Site

Arlington, Texas, United States

Location

Synergy Research Site

Austin, Texas, 78756, United States

Location

Synergy Research Site

Austin, Texas, 78758, United States

Location

Synergy Research Site

Carrollton, Texas, 75010, United States

Location

Synergy Research Site

Dallas, Texas, 75230, United States

Location

Synergy Research Site

Houston, Texas, 77074, United States

Location

Synergy Research Site

Houston, Texas, 77099, United States

Location

Synergy Research Site

Plano, Texas, 75093, United States

Location

Synergy Research Site

San Antonio, Texas, 78229, United States

Location

Synergy Research Site

Webster, Texas, 77598, United States

Location

Synergy Research Site

Bountiful, Utah, 84010, United States

Location

Synergy Research Site

Ogden, Utah, 84405, United States

Location

Synergy Research Site

Sandy City, Utah, 84092, United States

Location

Synergy Research Site

St. George, Utah, 84790, United States

Location

Synergy Research Site

Alexandria, Virginia, 22304, United States

Location

Synergy Research Site

Charlottesville, Virginia, 22911, United States

Location

Synergy Research Site

Lynchburg, Virginia, 24502, United States

Location

Synergy Research Site

Newport News, Virginia, 23606, United States

Location

Synergy Research Site

Bellevue, Washington, 98004, United States

Location

Synergy Research Site

Spokane, Washington, 99208, United States

Location

Synergy Research Site

Charleston, West Virginia, 25304, United States

Location

Synergy Research Site

Morgantown, West Virginia, 26505, United States

Location

Synergy Research Site

Milwaukee, Wisconsin, 53215, United States

Location

Synergy Research Site

Wauwatosa, Wisconsin, 53226, United States

Location

Related Publications (3)

• Brenner DM, Shin AS, Laitman AP, Deutsch JK, Kunkel DC. The Effectiveness of Plecanatide for Treating Constipation and Bloating in Patients Aged 18 to 40 Years With Irritable Bowel Syndrome: Utilization of a New Composite Trisymptom Endpoint. J Gastroenterol Hepatol. 2025 Dec;40(12):2890-2897. doi: 10.1111/jgh.70119. Epub 2025 Nov 10.

  PMID: 41214272 DERIVED

• Cash BD, Sharma A, Walker A, Laitman AP, Chang L. Plecanatide for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation: Post hoc analyses of placebo-controlled trials in adults with severe constipation. Neurogastroenterol Motil. 2023 Sep;35(9):e14632. doi: 10.1111/nmo.14632. Epub 2023 Jun 18.

  PMID: 37332239 DERIVED

• Menees SB, Franklin H, Chey WD. Evaluation of Plecanatide for the Treatment of Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation in Patients 65 Years or Older. Clin Ther. 2020 Jul;42(7):1406-1414.e4. doi: 10.1016/j.clinthera.2020.05.012. Epub 2020 Jul 10.

  PMID: 32660770 DERIVED

MeSH Terms

Interventions

plecanatide

Results Point of Contact

• Title: VP Regulatory Affairs & Clinical QA
• Organization: Synergy Pharmaceuticals Inc.

ejaeger@synergypharma.com

646-675-7283

Study Officials

• Paul F.C. Eng, PhD

  Synergy Pharmaceuticals Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 20, 2015
• First Posted: March 13, 2015
• Study Start: December 1, 2014
• Primary Completion: December 1, 2016
• Study Completion: February 1, 2017
• Last Updated: June 14, 2019
• Results First Posted: June 14, 2019

Record last verified: 2019-06

Locations

US (155)