Long Term Safety Study of Plecanatide
IBS-C
An Open Label, Long Term Safety and Tolerability Study of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
1 other identifier
interventional
2,272
1 country
204
Brief Summary
Multi-center, open-label, long-term safety study
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Jan 2016
204 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2016
CompletedFirst Submitted
Initial submission to the registry
February 29, 2016
CompletedFirst Posted
Study publicly available on registry
March 11, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedResults Posted
Study results publicly available
August 18, 2020
CompletedAugust 18, 2020
August 1, 2020
1.3 years
February 29, 2016
August 5, 2020
August 5, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
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.
up to 53 weeks
Study Arms (1)
Plecanatide
EXPERIMENTALPlecanatide 6.0 mg tablets
Interventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (204)
Synergy Research Site
Athens, Alabama, United States
Synergy Research Site
Birmingham, Alabama, United States
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Dothan, Alabama, United States
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Foley, Alabama, United States
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Guntersville, Alabama, United States
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Huntsville, Alabama, United States
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Saraland, Alabama, United States
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Chandler, Arizona, United States
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Phoenix, Arizona, United States
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Surprise, Arizona, United States
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Tucson, Arizona, United States
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Conway, Arkansas, United States
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Glendale, Arkansas, United States
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Little Rock, Arkansas, United States
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Artesia, California, United States
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Canoga Park, California, United States
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Carmichael, California, United States
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Chula Vista, California, United States
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Corona, California, United States
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Costa Mesa, California, United States
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El Cajon, California, United States
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Encino, California, United States
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Foothill Ranch, California, United States
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Fountain Valley, California, United States
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Garden Grove, California, United States
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Huntington Beach, California, United States
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La Mesa, California, United States
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La Mirada, California, United States
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Laguna Hills, California, United States
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Lancaster, California, United States
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Lomita, California, United States
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Long Beach, California, United States
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Los Angeles, California, United States
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North Hollywood, California, United States
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Northridge, California, United States
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Orange, California, United States
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Placentia, California, United States
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Riverside, California, United States
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San Bernardino, California, United States
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San Diego, California, United States
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San Marino, California, United States
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Sherman Oaks, California, United States
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Thousand Oaks, California, United States
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Colorado Springs, Colorado, United States
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Denver, Colorado, United States
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Lafayette, Colorado, United States
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Bristol, Connecticut, United States
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Hamden, Connecticut, United States
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Atlantis, Florida, United States
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Boca Raton, Florida, United States
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Boynton Beach, Florida, United States
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Bradenton, Florida, United States
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Brandon, Florida, United States
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Brooksville, Florida, United States
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Clearwater, Florida, United States
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Cutler Bay, Florida, United States
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DeLand, Florida, United States
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Fort Lauderdale, Florida, United States
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Hialeah, Florida, United States
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Homestead, Florida, United States
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Inverness, Florida, United States
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Jacksonville, Florida, United States
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Lauderdale Lakes, Florida, United States
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Miami, Florida, United States
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Miami Lakes, Florida, United States
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Miami Springs, Florida, United States
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Naples, Florida, United States
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North Miami Beach, Florida, United States
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Orange Park, Florida, United States
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Orlando, Florida, United States
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Ormond Beach, Florida, United States
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Oviedo, Florida, United States
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Pembroke Pines, Florida, United States
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Pinellas Park, Florida, United States
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Port Orange, Florida, United States
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St. Petersburg, Florida, United States
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Tamarac, Florida, United States
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Tampa, Florida, United States
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Atlanta, Georgia, United States
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Marietta, Georgia, United States
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Snellville, Georgia, United States
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Blackfoot, Idaho, United States
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Boise, Idaho, United States
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Meridian, Idaho, United States
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Blue Island, Illinois, United States
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Chicago, Illinois, United States
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Evanston, Illinois, United States
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Evergreen Park, Illinois, United States
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Hoffman Estates, Illinois, United States
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Morton, Illinois, United States
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Oak Lawn, Illinois, United States
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Schaumburg, Illinois, United States
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Brownsburg, Indiana, United States
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Indianapolis, Indiana, United States
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Topeka, Kansas, United States
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Wichita, Kansas, United States
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Madisonville, Kentucky, United States
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Owensboro, Kentucky, United States
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Baton Rouge, Louisiana, United States
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Crowley, Louisiana, United States
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Mandeville, Louisiana, United States
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Marrero, Louisiana, United States
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Metairie, Louisiana, United States
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New Orleans, Louisiana, United States
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Shreveport, Louisiana, United States
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Annapolis, Maryland, United States
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Baltimore, Maryland, United States
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Hagerstown, Maryland, United States
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Oxon Hill, Maryland, United States
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Marlborough, Massachusetts, United States
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Chesterfield, Michigan, United States
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Flint, Michigan, United States
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Wyoming, Michigan, United States
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Jackson, Mississippi, United States
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Port Gibson, Mississippi, United States
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Chesterfield, Missouri, United States
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Hazelwood, Missouri, United States
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St Louis, Missouri, United States
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Missoula, Montana, United States
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Omaha, Nebraska, United States
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Marlton, New Jersey, United States
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Albuquerque, New Mexico, United States
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Brooklyn, New York, United States
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Great Neck, New York, United States
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Hopewell Junction, New York, United States
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Kew Gardens, New York, United States
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New Windsor, New York, United States
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New York, New York, United States
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North Massapequa, New York, United States
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Poughkeepsie, New York, United States
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Asheboro, North Carolina, United States
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Cary, North Carolina, United States
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Charlotte, North Carolina, United States
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Charlotte, North Carolina, United States
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Davidson, North Carolina, United States
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Fayetteville, North Carolina, United States
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High Point, North Carolina, United States
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Jacksonville, North Carolina, United States
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Kinston, North Carolina, United States
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Raleigh, North Carolina, United States
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Salisbury, North Carolina, United States
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Wilmington, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Fargo, North Dakota, United States
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Beavercreek, Ohio, United States
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Cincinnati, Ohio, United States
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Columbus, Ohio, United States
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Dayton, Ohio, United States
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Englewood, Ohio, United States
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Kettering, Ohio, United States
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Mentor, Ohio, United States
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Middleburg Heights, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Portland, Oregon, United States
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Lansdale, Pennsylvania, United States
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Levittown, Pennsylvania, United States
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Philadelphia, Pennsylvania, United States
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Smithfield, Pennsylvania, United States
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Anderson, South Carolina, United States
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Gaffney, South Carolina, United States
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Greer, South Carolina, United States
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Rapid City, South Dakota, United States
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Athens, Tennessee, United States
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Chattanooga, Tennessee, United States
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Fayetteville, Tennessee, United States
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Franklin, Tennessee, United States
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Hermitage, Tennessee, United States
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Jackson, Tennessee, United States
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Kingsport, Tennessee, United States
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Knoxville, Tennessee, United States
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Memphis, Tennessee, United States
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Nashville, Tennessee, United States
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Austin, Texas, United States
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Beaumont, Texas, United States
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Carrollton, Texas, United States
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Channelview, Texas, United States
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Dallas, Texas, United States
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Houston, Texas, United States
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Humble, Texas, United States
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Lampasas, Texas, United States
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McKinney, Texas, United States
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Missouri City, Texas, United States
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Plano, Texas, United States
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Port Arthur, Texas, United States
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San Antonio, Texas, United States
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Sugar Land, Texas, United States
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Ogden, Utah, United States
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Orem, Utah, United States
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Sandy City, Utah, United States
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St. George, Utah, United States
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Charlottesville, Virginia, United States
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Chesapeake, Virginia, United States
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Fairfax, Virginia, United States
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Lynchburg, Virginia, United States
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Newport News, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Bellevue, Washington, United States
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Spokane, Washington, United States
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Charleston, West Virginia, United States
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Kingwood, West Virginia, United States
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Morgantown, West Virginia, United States
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La Crosse, Wisconsin, United States
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Milwaukee, Wisconsin, United States
Related Publications (1)
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.
PMID: 30277094DERIVED
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Results Point of Contact
- Title
- Matt Markovich
- Organization
- Bausch Health
Study Officials
- STUDY DIRECTOR
Angela Bulawski
Bausch Health
Publication Agreements
- PI is Sponsor Employee
- No
- Restriction Type
- OTHER
- Restrictive Agreement
- Yes
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 29, 2016
First Posted
March 11, 2016
Study Start
January 1, 2016
Primary Completion
May 1, 2017
Study Completion
June 1, 2017
Last Updated
August 18, 2020
Results First Posted
August 18, 2020
Record last verified: 2020-08