Irritable Bowel SyndromePhase 3IBS-CNCT02706483

Long Term Safety Study of Plecanatide

A Phase 3 study testing Plecanatide in people with Irritable Bowel Syndrome, run by Bausch Health Americas, Inc. at 204 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Multi-center, open-label, long-term safety study Read more about this study

Who is it for?: Ages 18 to 85 years
Conditions the study is for: Irritable Bowel Syndrome
What is being tested?: Plecanatide
Type of treatment: Pill or oral medicine
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2,272 participants
Where: 204 sitesUnited States
Study dates: Jan 2016to Jun 2017
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 85 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

204 sites in 1 country.

City, postcode or hospital

204 sites in 1 country

United States204 sites

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

Other trials in United States

About this study

Official title: 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

Read the 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.

Conditions: Irritable Bowel Syndrome
Being tested: Plecanatide
Medical subject headings: Irritable Bowel Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PlecanatideDrug

Study groups in NCT02706483
Study group	Role	What they receive
Plecanatide	Experimental	Plecanatide 6.0 mg tablets Receives: Drug: Plecanatide

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Jan 2016Jun 2017

First posted11 Mar 2016 (estimated)
Study startJan 2016
Primary completionMay 2017
Study completionJun 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (1)Papers the sponsor has linked to this study.
Other trials for Irritable Bowel SyndromeStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 2,272 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02706483
Sponsor's protocol ID: SP304203-06
Acronym: IBS-C
Status last verified: Aug 2020
First submitted: 29 Feb 2016
Last updated: 18 Aug 2020
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Barish CF, Crozier RA, Griffin PH. Long-term treatment with plecanatide was safe and tolerable in patients with irritable bowel syndrome with constipation. Curr Med Res Opin. 2019 Jan;35(1):81-85. doi: 10.1080/03007995.2018.1527303. Epub 2018 Oct 9.
PubMed 30277094

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
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Nutritional Management of the Irritable Bowel Syndrome(IBS): The Role of the Mediterranean Diet (MD)
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NEUROMODULATION WITH TRANSCUTANEOUS AURICULAR VAGUS NERVE STIMULATION IN ADULTS WITH IRRITABLE BOWEL SYNDROME: A RANDOMIZED, SINGLE-BLIND, SHAM-CONTROLLED CROSSOVER STUDY
Irritable Bowel Syndrome (IBS)

All Irritable Bowel Syndrome trials

Study at a glance

From the registry record, last updated by the sponsor on 18 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: An Open Label, Long Term Safety and Tolerability Study of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
ClinicalTrials.gov ID: NCT02706483
Acronym / sponsor ID: IBS-C / SP304203-06
Conditions: Irritable Bowel Syndrome
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 2,272 participants (actual)
Lead sponsor: Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
Study start: Jan 2016
Primary completion: May 2017 (actual)
Study completion: Jun 2017 (actual)
First posted: 11 Mar 2016 (estimated)
Results: Posted 18 Aug 2020

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Detailed description

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 design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Plecanatide	Experimental	Drug: PlecanatidePlecanatide 6.0 mg tablets

Who may qualify

Ages: 18 to 85 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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 (5 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Plecanatide	Drug	Plecanatide

Primary outcome

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.

Results and safety

Results posted to the registry on 18 Aug 2020, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Plecanatide	2,272	1,842

Primary outcome: Number of Participants With Treatment Related Adverse Events.

Time frame: up to 53 weeks. Count of participants. Unit: Participants

Measure	Plecanatide n = 2272
Value	205

Adverse events

Time frame: Up to 53 weeks.. Other adverse events reported at 1% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Plecanatide	45 of 2,272 (2%)	341 of 2,272 (15%)	1 of 2,272

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2020.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 30277094Barish CF, Crozier RA, Griffin PH. Long-term treatment with plecanatide was safe and tolerable in patients with irritable bowel syndrome with constipation. Curr Med Res Opin. 2019 Jan;35(1):81-85. doi: 10.1080/03007995.2018.1527303. Epub 2018 Oct 9.

Related trials for Irritable Bowel Syndrome

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Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruiting
Nutritional Management of the Irritable Bowel Syndrome(IBS): The Role of the Mediterranean Diet (MD)
Irritable Bowel Syndrome
Not yet recruiting
The Mechanism Underlying the Analgesic Effect of the Music of IBS Pain
Abdominal Pain/ Discomfort, Irritable Bowel Syndrome
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Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
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Irritable Bowel Syndrome (IBS)

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Angela Bulawski study director

Bausch Health Americas, Inc.

204 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Plecanatide in people with Irritable Bowel Syndrome, run by Bausch Health Americas, Inc. at 204 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 204 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 18 Aug 2020). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Treatment Related Adverse Events. (time frame: up to 53 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02706483, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2020.