Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C)
NCT ID: NCT02493452
Last Updated: 2019-06-14
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE3
1135 participants
INTERVENTIONAL
2015-06-30
2017-02-28
Brief Summary
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Detailed Description
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Screening/Baseline: Patients will undergo an up to 28-day Screening/Baseline period to allow for any necessary diagnostic procedures, allow for required washout of medications and to determine study eligibility. If otherwise eligible based on screening criteria, patients will undergo a 2-week baseline assessment using an electronic diary where they will record daily assessments of bowel movements (BMs), stool consistency (Bristol Stool Form Scale-BSFS), abdominal pain and other IBS-related symptoms. Data from the two-week electronic diary assessment just prior to the randomization visit will be used to confirm IBS-C and study eligibility as well as define the patient's baseline from which change will be determined.
Treatment: Patients who meet all entry criteria will be randomized (1:1:1) to one of three blinded treatment groups on Day 1 of the Treatment period. Patients will take an oral dose of study drug OD for 12 weeks and continue the daily electronic diaries (BMs, rescue medication use, abdominal pain, and other symptoms). During treatment weeks 4, 8, and 12, patients will return to the clinic to undergo safety and efficacy assessments.
Post-Treatment: For 2 weeks after completing dosing, patients will continue to complete daily electronic diaries. Patients will then return to the clinical site for a final follow-up visit during Week 14 following randomization.
The planned duration of participation in this study will be at least 116 days from signing of informed consent through post-treatment or up to approximately 135 days with visit windows considered.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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3.0 mg plecanatide
Plecanatide 3.0 mg dosed daily for 12 weeks
Plecanatide
6.0 mg plecanatide
Plecanatide 6.0 mg dosed daily for 12 weeks
Plecanatide
Matching placebo
Placebo dosed daily for 12 weeks
Placebo
Interventions
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Plecanatide
Placebo
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
* Refusal or inability to complete daily Episodic (real-time) BM / RM calls, End of Day daily Calls, and/or complete electronic questionnaires
* BMI ≥ 40 or \< 18
* Women of child bearing potential who refuse to use an acceptable method of birth control for the duration of the trial
* Women who are pregnant or lactating
* Diagnosis of IBS-D or IBS-M
* Organic or obstructive disease of the small or large intestine
* Use of laxatives other than the study-supplied rescue medication (Dulcolax®, bisacodyl)
* Use of a prohibited concomitant medication within the time frame prior to screening outlined in the study protocol for that medication
* Unstable medical illness
* Bilirubin \> 3X ULN in the absence of a conjugation defect
* Any laboratory value \> 3X ULN unless discussed and approved by the study Medical Monitor
18 Years
85 Years
ALL
No
Sponsors
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Bausch Health Americas, Inc.
INDUSTRY
Responsible Party
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Principal Investigators
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Paul F.C. Eng, PhD
Role: STUDY_DIRECTOR
Synergy Pharmaceuticals Inc.
Locations
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Synergy Research Site
Birmingham, Alabama, United States
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Birmingham, 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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Glendale, 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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Little Rock, Arkansas, United States
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Canoga Park, California, United States
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Carmichael, California, United States
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Chino, California, United States
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Chula Vista, 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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Garden Grove, California, United States
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Huntington Beach, California, United States
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Irvine, 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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Mission Hills, California, United States
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Montclair, California, United States
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Northridge, California, United States
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Norwalk, California, United States
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Oceanside, California, United States
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Orange, California, United States
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Orangevale, California, United States
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Placentia, California, United States
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Riverside, 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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Santa Ana, California, United States
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Sherman 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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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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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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Fort Lauderdale, Florida, United States
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Fort Lauderdale, Florida, United States
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Hialeah, Florida, United States
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Hialeah, Florida, United States
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Hialeah, Florida, United States
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Jacksonville, Florida, United States
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Lauderdale Lakes, Florida, United States
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Maitland, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, Florida, United States
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Miami, 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 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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Orlando, Florida, United States
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Ormond Beach, 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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Tamarac, Florida, United States
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Tampa, Florida, United States
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Tampa, Florida, United States
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Williston, Florida, United States
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Atlanta, Georgia, United States
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Atlanta, Georgia, United States
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Decatur, Georgia, United States
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Lilburn, 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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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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Wichita, Kansas, United States
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Madisonville, Kentucky, United States
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Owensboro, Kentucky, United States
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Marrero, Louisiana, United States
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Annapolis, Maryland, United States
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Catonsville, Maryland, United States
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Oxon Hill, Maryland, United States
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Towson, Maryland, United States
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Marlborough, Massachusetts, United States
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Quincy, Massachusetts, United States
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Kalamazoo, Michigan, United States
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Port Gibson, Mississippi, United States
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Chesterfield, Missouri, United States
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St Louis, 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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Las Vegas, Nevada, United States
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Blackwood, New Jersey, United States
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Egg Harbor, New Jersey, United States
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Vineland, New Jersey, United States
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Albuquerque, New Mexico, 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 York, New York, United States
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Poughkeepsie, New York, United States
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Chapel Hill, 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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Raleigh, North Carolina, United States
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Salisbury, North Carolina, United States
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Winston-Salem, North Carolina, United States
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Cincinnati, Ohio, United States
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Cincinnati, 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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Dayton, Ohio, United States
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Franklin, 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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Wadsworth, Ohio, United States
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Oklahoma City, Oklahoma, United States
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Doylestown, Pennsylvania, 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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Anderson, South Carolina, United States
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Greer, South Carolina, United States
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Mt. Pleasant, South Carolina, 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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Austin, Texas, United States
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Austin, Texas, United States
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Baytown, Texas, United States
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Beaumont, Texas, United States
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Channelview, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Dallas, Texas, United States
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Houston, 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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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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San Antonio, 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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Orem, Utah, United States
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West Valley City, Utah, United States
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Chesapeake, Virginia, United States
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Fairfax, Virginia, United States
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Norfolk, Virginia, United States
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Richmond, Virginia, United States
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Richmond, Virginia, United States
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Spokane, Washington, United States
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Vancouver, Washington, United States
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Kingwood, West Virginia, United States
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La Crosse, Wisconsin, United States
Countries
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References
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Cash BD, Sharma A, Walker A, Laitman AP, Chang L. Plecanatide for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation: Post hoc analyses of placebo-controlled trials in adults with severe constipation. Neurogastroenterol Motil. 2023 Sep;35(9):e14632. doi: 10.1111/nmo.14632. Epub 2023 Jun 18.
Menees SB, Franklin H, Chey WD. Evaluation of Plecanatide for the Treatment of Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation in Patients 65 Years or Older. Clin Ther. 2020 Jul;42(7):1406-1414.e4. doi: 10.1016/j.clinthera.2020.05.012. Epub 2020 Jul 10.
Other Identifiers
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SP304203-05
Identifier Type: -
Identifier Source: org_study_id
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