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Long Term Safety Study of Plecanatide

NCT ID: NCT02706483

Last Updated: 2020-08-18

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

2272 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2017-06-30

Brief Summary

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

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Detailed Description

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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

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Irritable Bowel Syndrome

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Plecanatide

Plecanatide 6.0 mg tablets

Group Type EXPERIMENTAL

Plecanatide

Intervention Type DRUG

Interventions

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Plecanatide

Intervention Type DRUG

Eligibility Criteria

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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.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Angela Bulawski

Role: STUDY_DIRECTOR

Bausch Health

Locations

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Synergy Research Site

Athens, Alabama, United States

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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

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Countries

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United States

References

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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.

Reference Type DERIVED
PMID: 30277094 (View on PubMed)

Provided Documents

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Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

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SP304203-06

Identifier Type: -

Identifier Source: org_study_id

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