Long Term Safety Study of Plecanatide (IBS-C)

August 5, 2020 updated by: Bausch Health Americas, Inc.

An Open Label, Long Term Safety and Tolerability Study of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Multi-center, open-label, long-term safety study

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

This is a phase 3, multicenter, open-label, long-term safety and tolerability study of 6 mg daily dose of plecanatide administered orally. Patients who are Study Completers or Eligible Screen Failures whose eligibility is confirmed at the end of their participation in the double-blind plecanatide studies SP304203-04 or SP304203-05 will be enrolled.

Beginning on Day 1, patients will take one (1) plecanatide 6.0 mg tablet in the clinic and thereafter every morning with approximately 240 mL (8 ounces) of liquid, with or without meals.

Safety and tolerability assessments and patients' self-assessment of disease severity will be performed according to the Schedule of Assessments.

Patients who discontinue early from the study will undergo an Early Withdrawal (EW) visit within 5 days after stopping study drug.

Study Type

Interventional

Enrollment (Actual)

2272

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
        • Synergy Research Site
      • Birmingham, Alabama, United States
        • Synergy Research Site
      • Dothan, Alabama, United States
        • Synergy Research Site
      • Foley, Alabama, United States
        • Synergy Research Site
      • Guntersville, Alabama, United States
        • Synergy Research Site
      • Huntsville, Alabama, United States
        • Synergy Research Site
      • Saraland, Alabama, United States
        • Synergy Research Site
    • Arizona
      • Chandler, Arizona, United States
        • Synergy Research Site
      • Phoenix, Arizona, United States
        • Synergy Research Site
      • Surprise, Arizona, United States
        • Synergy Research Site
      • Tucson, Arizona, United States
        • Synergy Research Site
    • Arkansas
      • Conway, Arkansas, United States
        • Synergy Research Site
      • Glendale, Arkansas, United States
        • Synergy Research Site
      • Little Rock, Arkansas, United States
        • Synergy Research Site
    • California
      • Artesia, California, United States
        • Synergy Research Site
      • Canoga Park, California, United States
        • Synergy Research Site
      • Carmichael, California, United States
        • Synergy Research Site
      • Chula Vista, California, United States
        • Synergy Research Site
      • Corona, California, United States
        • Synergy Research Site
      • Costa Mesa, California, United States
        • Synergy Research Site
      • El Cajon, California, United States
        • Synergy Research Site
      • Encino, California, United States
        • Synergy Research Site
      • Foothill Ranch, California, United States
        • Synergy Research Site
      • Fountain Valley, California, United States
        • Synergy Research Site
      • Garden Grove, California, United States
        • Synergy Research Site
      • Huntington Beach, 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
      • Lomita, California, United States
        • Synergy Research Site
      • Long Beach, California, United States
        • Synergy Research Site
      • Los Angeles, California, United States
        • Synergy Research Site
      • North Hollywood, California, United States
        • Synergy Research Site
      • Northridge, California, United States
        • Synergy Research Site
      • Orange, California, United States
        • Synergy Research Site
      • Placentia, California, United States
        • Synergy Research Site
      • Riverside, California, United States
        • Synergy Research Site
      • San Bernardino, California, United States
        • Synergy Research Site
      • San Diego, California, United States
        • Synergy Research Site
      • San Marino, California, United States
        • Synergy Research Site
      • Sherman Oaks, California, United States
        • Synergy Research Site
      • Thousand Oaks, California, United States
        • Synergy Research Site
    • Colorado
      • Colorado Springs, Colorado, United States
        • Synergy Research Site
      • Denver, Colorado, United States
        • Synergy Research Site
      • Lafayette, Colorado, United States
        • Synergy Research Site
    • Connecticut
      • Bristol, Connecticut, United States
        • Synergy Research Site
      • Hamden, Connecticut, United States
        • Synergy Research Site
    • Florida
      • Atlantis, Florida, United States
        • Synergy Research Site
      • Boca Raton, Florida, United States
        • Synergy Research Site
      • Boynton Beach, Florida, United States
        • Synergy Research Site
      • Bradenton, Florida, United States
        • Synergy Research Site
      • Brandon, Florida, United States
        • Synergy Research Site
      • Brooksville, Florida, United States
        • Synergy Research Site
      • Clearwater, Florida, United States
        • Synergy Research Site
      • Cutler Bay, Florida, United States
        • Synergy Research Site
      • DeLand, Florida, United States
        • Synergy Research Site
      • Fort Lauderdale, Florida, United States
        • Synergy Research Site
      • Hialeah, 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
      • Lauderdale Lakes, 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
      • Naples, Florida, United States
        • Synergy Research Site
      • North Miami Beach, Florida, United States
        • Synergy Research Site
      • Orange Park, 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
      • Pembroke Pines, Florida, United States
        • Synergy Research Site
      • Pinellas Park, Florida, United States
        • Synergy Research Site
      • Port Orange, Florida, United States
        • Synergy Research Site
      • Saint Petersburg, Florida, United States
        • Synergy Research Site
      • Tamarac, Florida, United States
        • Synergy Research Site
      • Tampa, Florida, United States
        • Synergy Research Site
    • Georgia
      • Atlanta, Georgia, United States
        • Synergy Research Site
      • Marietta, Georgia, United States
        • Synergy Research Site
      • Snellville, Georgia, United States
        • Synergy Research Site
    • Idaho
      • Blackfoot, Idaho, United States
        • Synergy Research Site
      • Boise, Idaho, United States
        • Synergy Research Site
      • Meridian, Idaho, United States
        • Synergy Research Site
    • Illinois
      • Blue Island, Illinois, 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
      • Hoffman Estates, Illinois, United States
        • Synergy Research Site
      • Morton, Illinois, United States
        • Synergy Research Site
      • Oak Lawn, Illinois, United States
        • Synergy Research Site
      • Schaumburg, Illinois, United States
        • Synergy Research Site
    • Indiana
      • Brownsburg, Indiana, United States
        • Synergy Research Site
      • Indianapolis, Indiana, United States
        • Synergy Research Site
    • Kansas
      • Topeka, Kansas, United States
        • Synergy Research Site
      • Wichita, Kansas, United States
        • Synergy Research Site
    • Kentucky
      • Madisonville, Kentucky, United States
        • Synergy Research Site
      • Owensboro, Kentucky, United States
        • Synergy Research Site
    • Louisiana
      • Baton Rouge, Louisiana, United States
        • Synergy Research Site
      • Crowley, Louisiana, United States
        • Synergy Research Site
      • Mandeville, Louisiana, United States
        • Synergy Research Site
      • Marrero, Louisiana, United States
        • Synergy Research Site
      • Metairie, Louisiana, United States
        • Synergy Research Site
      • New Orleans, Louisiana, United States
        • Synergy Research Site
      • Shreveport, Louisiana, United States
        • Synergy Research Site
    • Maryland
      • Annapolis, Maryland, United States
        • Synergy Research Site
      • Baltimore, Maryland, United States
        • Synergy Research Site
      • Hagerstown, Maryland, United States
        • Synergy Research Site
      • Oxon Hill, Maryland, United States
        • Synergy Research Site
    • Massachusetts
      • Marlborough, Massachusetts, United States
        • Synergy Research Site
    • Michigan
      • Chesterfield, Michigan, United States
        • Synergy Research Site
      • Flint, Michigan, United States
        • Synergy Research Site
      • Wyoming, Michigan, United States
        • Synergy Research Site
    • Mississippi
      • Jackson, Mississippi, United States
        • Synergy Research Site
      • Port Gibson, Mississippi, United States
        • Synergy Research Site
    • Missouri
      • Chesterfield, Missouri, United States
        • Synergy Research Site
      • Hazelwood, Missouri, United States
        • Synergy Research Site
      • Saint Louis, Missouri, United States
        • Synergy Research Site
    • Montana
      • Missoula, Montana, United States
        • Synergy Research Site
    • Nebraska
      • Omaha, Nebraska, United States
        • Synergy Research Site
    • New Jersey
      • Marlton, New Jersey, United States
        • Synergy Research Site
    • New Mexico
      • Albuquerque, New Mexico, United States
        • Synergy Research Site
    • New York
      • Brooklyn, New York, United States
        • Synergy Research Site
      • Great Neck, New York, United States
        • Synergy Research Site
      • Hopewell Junction, New York, United States
        • Synergy Research Site
      • Kew Gardens, 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
      • Poughkeepsie, New York, United States
        • Synergy Research Site
    • North Carolina
      • 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
      • Davidson, North Carolina, United States
        • Synergy Research Site
      • Fayetteville, North Carolina, United States
        • Synergy Research Site
      • High Point, North Carolina, United States
        • Synergy Research Site
      • Jacksonville, North Carolina, United States
        • Synergy Research Site
      • Kinston, North Carolina, United States
        • Synergy Research Site
      • Raleigh, North Carolina, United States
        • Synergy Research Site
      • Salisbury, North Carolina, United States
        • Synergy Research Site
      • Wilmington, North Carolina, United States
        • Synergy Research Site
      • Winston-Salem, North Carolina, United States
        • Synergy Research Site
    • North Dakota
      • Fargo, North Dakota, United States
        • Synergy Research Site
    • Ohio
      • Beavercreek, Ohio, United States
        • Synergy Research Site
      • Cincinnati, Ohio, United States
        • Synergy Research Site
      • Columbus, Ohio, United States
        • Synergy Research Site
      • Dayton, Ohio, United States
        • Synergy Research Site
      • Englewood, Ohio, United States
        • Synergy Research Site
      • Kettering, Ohio, United States
        • Synergy Research Site
      • Mentor, Ohio, United States
        • Synergy Research Site
      • Middleburg Heights, Ohio, United States
        • Synergy Research Site
    • Oklahoma
      • Oklahoma City, Oklahoma, United States
        • Synergy Research Site
    • Oregon
      • Portland, Oregon, United States
        • Synergy Research Site
    • Pennsylvania
      • Lansdale, Pennsylvania, United States
        • Synergy Research Site
      • Levittown, Pennsylvania, United States
        • Synergy Research Site
      • Philadelphia, Pennsylvania, United States
        • Synergy Research Site
      • Smithfield, Pennsylvania, United States
        • Synergy Research Site
    • South Carolina
      • Anderson, South Carolina, United States
        • Synergy Research Site
      • Gaffney, South Carolina, United States
        • Synergy Research Site
      • Greer, South Carolina, United States
        • Synergy Research Site
    • South Dakota
      • Rapid City, South Dakota, United States
        • Synergy Research Site
    • Tennessee
      • Athens, Tennessee, United States
        • Synergy Research Site
      • Chattanooga, Tennessee, United States
        • Synergy Research Site
      • Fayetteville, Tennessee, United States
        • Synergy Research Site
      • Franklin, Tennessee, United States
        • Synergy Research Site
      • Hermitage, Tennessee, United States
        • Synergy Research Site
      • Jackson, Tennessee, United States
        • Synergy Research Site
      • Kingsport, Tennessee, United States
        • Synergy Research Site
      • Knoxville, Tennessee, United States
        • Synergy Research Site
      • Memphis, Tennessee, United States
        • Synergy Research Site
      • Nashville, Tennessee, United States
        • Synergy Research Site
    • Texas
      • Austin, Texas, United States
        • Synergy Research Site
      • Beaumont, Texas, United States
        • Synergy Research Site
      • Carrollton, Texas, United States
        • Synergy Research Site
      • Channelview, Texas, United States
        • Synergy Research Site
      • Dallas, Texas, United States
        • Synergy Research Site
      • Houston, Texas, United States
        • Synergy Research Site
      • Humble, Texas, United States
        • Synergy Research Site
      • Lampasas, Texas, United States
        • Synergy Research Site
      • McKinney, Texas, United States
        • Synergy Research Site
      • Missouri City, Texas, United States
        • Synergy Research Site
      • Plano, Texas, United States
        • Synergy Research Site
      • Port Arthur, Texas, United States
        • Synergy Research Site
      • San Antonio, Texas, United States
        • Synergy Research Site
      • Sugar Land, Texas, United States
        • Synergy Research Site
    • Utah
      • Ogden, Utah, United States
        • Synergy Research Site
      • Orem, Utah, United States
        • Synergy Research Site
      • Saint George, Utah, United States
        • Synergy Research Site
      • Sandy, Utah, United States
        • Synergy Research Site
    • Virginia
      • Charlottesville, Virginia, United States
        • Synergy Research Site
      • Chesapeake, Virginia, United States
        • Synergy Research Site
      • Fairfax, Virginia, United States
        • Synergy Research Site
      • Lynchburg, Virginia, United States
        • Synergy Research Site
      • Newport News, Virginia, United States
        • Synergy Research Site
      • Norfolk, Virginia, United States
        • Synergy Research Site
      • Richmond, Virginia, United States
        • Synergy Research Site
    • Washington
      • Bellevue, Washington, United States
        • Synergy Research Site
      • Spokane, Washington, United States
        • Synergy Research Site
    • West Virginia
      • Charleston, West Virginia, United States
        • Synergy Research Site
      • Kingwood, West Virginia, United States
        • Synergy Research Site
      • Morgantown, West Virginia, United States
        • Synergy Research Site
    • Wisconsin
      • La Crosse, Wisconsin, United States
        • Synergy Research Site
      • Milwaukee, Wisconsin, United States
        • 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:

Patients with documented diagnosis of IBS-C who:

  • Completed plecanatide study SP304203-04 or SP304203-05, were compliant with the previous study's requirements, and did not experience any Serious Adverse Event (SAE) deemed related to study drug during the course of the previous study, OR
  • Failed screening in study SP304203-04 or SP304203-05 due to diary noncompliance (an exclusion in the core study) or due to an administrative reason and is allowed to enter this study by notification from Sponsor or delegate.

Key Exclusion Criteria:

  • Patient is unwilling or unable to: participate in the study for the required duration, understand and sign the informed consent form (ICF) and undergo all protocol related tests and procedures throughout the study.
  • Female patient of childbearing potential with a positive urine pregnancy test on Day 1.
  • Male and female patients of childbearing potential who do not agree to continue to use the method of birth control used in the core double-blind plecanatide study for the duration of this clinical trial.
  • Patient has experienced a significant negative change in health status during the course of participation in the core double-blind plecanatide study or after completion of the study.
  • In the opinion of the Investigator or Medical Monitor, it is not in the patient's best interest to participate in the study. The reason(s) for the patient's exclusion must be specified.

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: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Plecanatide
Plecanatide 6.0 mg tablets
Drug: Plecanatide

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of Participants With Treatment Related Adverse Events.
Time Frame: up to 53 weeks
Number of participants with adverse events with evidence to suggest a causal relationship between treatment and study drug.
up to 53 weeks

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

January 1, 2016

Primary Completion (Actual)

May 1, 2017

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

February 29, 2016

First Submitted That Met QC Criteria

March 7, 2016

First Posted (Estimate)

March 11, 2016

Study Record Updates

Last Update Posted (Actual)

August 18, 2020

Last Update Submitted That Met QC Criteria

August 5, 2020

Last Verified

August 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP304203-06

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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