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Multi-center, open-label, long-term safety study
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Plecanatide | Experimental | Plecanatide 6.0 mg tablets |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plecanatide | Drug |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Patients with documented diagnosis of IBS-C who:
Key Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Angela Bulawski | Bausch Health Americas, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Synergy Research Site | Athens | Alabama | United States | |||
| Synergy Research Site |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30277094 | Derived | 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. |
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Eligible subjects with IBS-C from SP304203-04 (NCT02387359), SP304203-05 (NCT02493452), and SP304-20212 (NCT01722318), and subjects that did not previously participate in any plecanatide study, were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | Plecanatide | Plecanatide 6.0 mg tablets Plecanatide |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jul 21, 2016 |
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| Birmingham |
| Alabama |
| United States |
| Synergy Research Site | Dothan | Alabama | United States |
| Synergy Research Site | Foley | Alabama | United States |
| Synergy Research Site | Guntersville | Alabama | United States |
| Synergy Research Site | Huntsville | Alabama | United States |
| Synergy Research Site | Saraland | Alabama | United States |
| Synergy Research Site | Chandler | Arizona | United States |
| Synergy Research Site | Phoenix | Arizona | United States |
| Synergy Research Site | Surprise | Arizona | United States |
| Synergy Research Site | Tucson | Arizona | United States |
| Synergy Research Site | Conway | Arkansas | United States |
| Synergy Research Site | Glendale | Arkansas | United States |
| Synergy Research Site | Little Rock | Arkansas | United States |
| Synergy Research Site | Artesia | California | United States |
| Synergy Research Site | Canoga Park | California | United States |
| Synergy Research Site | Carmichael | California | United States |
| Synergy Research Site | Chula Vista | California | United States |
| Synergy Research Site | Corona | California | United States |
| Synergy Research Site | Costa Mesa | California | United States |
| Synergy Research Site | El Cajon | California | United States |
| Synergy Research Site | Encino | California | United States |
| Synergy Research Site | Foothill Ranch | California | United States |
| Synergy Research Site | Fountain Valley | California | United States |
| Synergy Research Site | Garden Grove | California | United States |
| Synergy Research Site | Huntington Beach | California | United States |
| Synergy Research Site | La Mesa | California | United States |
| Synergy Research Site | La Mirada | California | United States |
| Synergy Research Site | Laguna Hills | California | United States |
| Synergy Research Site | Lancaster | California | United States |
| Synergy Research Site | Lomita | California | United States |
| Synergy Research Site | Long Beach | California | United States |
| Synergy Research Site | Los Angeles | California | United States |
| Synergy Research Site | North Hollywood | California | United States |
| Synergy Research Site | Northridge | California | United States |
| Synergy Research Site | Orange | California | United States |
| Synergy Research Site | Placentia | California | United States |
| Synergy Research Site | Riverside | California | United States |
| Synergy Research Site | San Bernardino | California | United States |
| Synergy Research Site | San Diego | California | United States |
| Synergy Research Site | San Marino | California | United States |
| Synergy Research Site | Sherman Oaks | California | United States |
| Synergy Research Site | Thousand Oaks | California | United States |
| Synergy Research Site | Colorado Springs | Colorado | United States |
| Synergy Research Site | Denver | Colorado | United States |
| Synergy Research Site | Lafayette | Colorado | United States |
| Synergy Research Site | Bristol | Connecticut | United States |
| Synergy Research Site | Hamden | Connecticut | United States |
| Synergy Research Site | Atlantis | Florida | United States |
| Synergy Research Site | Boca Raton | Florida | United States |
| Synergy Research Site | Boynton Beach | Florida | United States |
| Synergy Research Site | Bradenton | Florida | United States |
| Synergy Research Site | Brandon | Florida | United States |
| Synergy Research Site | Brooksville | Florida | United States |
| Synergy Research Site | Clearwater | Florida | United States |
| Synergy Research Site | Cutler Bay | Florida | United States |
| Synergy Research Site | DeLand | Florida | United States |
| Synergy Research Site | Fort Lauderdale | Florida | United States |
| Synergy Research Site | Hialeah | Florida | United States |
| Synergy Research Site | Homestead | Florida | United States |
| Synergy Research Site | Inverness | Florida | United States |
| Synergy Research Site | Jacksonville | Florida | United States |
| Synergy Research Site | Lauderdale Lakes | Florida | United States |
| Synergy Research Site | Miami | Florida | United States |
| Synergy Research Site | Miami Lakes | Florida | United States |
| Synergy Research Site | Miami Springs | Florida | United States |
| Synergy Research Site | Naples | Florida | United States |
| Synergy Research Site | North Miami Beach | Florida | United States |
| Synergy Research Site | Orange Park | Florida | United States |
| Synergy Research Site | Orlando | Florida | United States |
| Synergy Research Site | Ormond Beach | Florida | United States |
| Synergy Research Site | Oviedo | Florida | United States |
| Synergy Research Site | Pembroke Pines | Florida | United States |
| Synergy Research Site | Pinellas Park | Florida | United States |
| Synergy Research Site | Port Orange | Florida | United States |
| Synergy Research Site | St. Petersburg | Florida | United States |
| Synergy Research Site | Tamarac | Florida | United States |
| Synergy Research Site | Tampa | Florida | United States |
| Synergy Research Site | Atlanta | Georgia | United States |
| Synergy Research Site | Marietta | Georgia | United States |
| Synergy Research Site | Snellville | Georgia | United States |
| Synergy Research Site | Blackfoot | Idaho | United States |
| Synergy Research Site | Boise | Idaho | United States |
| Synergy Research Site | Meridian | Idaho | United States |
| Synergy Research Site | Blue Island | Illinois | United States |
| Synergy Research Site | Chicago | Illinois | United States |
| Synergy Research Site | Evanston | Illinois | United States |
| Synergy Research Site | Evergreen Park | Illinois | United States |
| Synergy Research Site | Hoffman Estates | Illinois | United States |
| Synergy Research Site | Morton | Illinois | United States |
| Synergy Research Site | Oak Lawn | Illinois | United States |
| Synergy Research Site | Schaumburg | Illinois | United States |
| Synergy Research Site | Brownsburg | Indiana | United States |
| Synergy Research Site | Indianapolis | Indiana | United States |
| Synergy Research Site | Topeka | Kansas | United States |
| Synergy Research Site | Wichita | Kansas | United States |
| Synergy Research Site | Madisonville | Kentucky | United States |
| Synergy Research Site | Owensboro | Kentucky | United States |
| Synergy Research Site | Baton Rouge | Louisiana | United States |
| Synergy Research Site | Crowley | Louisiana | United States |
| Synergy Research Site | Mandeville | Louisiana | United States |
| Synergy Research Site | Marrero | Louisiana | United States |
| Synergy Research Site | Metairie | Louisiana | United States |
| Synergy Research Site | New Orleans | Louisiana | United States |
| Synergy Research Site | Shreveport | Louisiana | United States |
| Synergy Research Site | Annapolis | Maryland | United States |
| Synergy Research Site | Baltimore | Maryland | United States |
| Synergy Research Site | Hagerstown | Maryland | United States |
| Synergy Research Site | Oxon Hill | Maryland | United States |
| Synergy Research Site | Marlborough | Massachusetts | United States |
| Synergy Research Site | Chesterfield | Michigan | United States |
| Synergy Research Site | Flint | Michigan | United States |
| Synergy Research Site | Wyoming | Michigan | United States |
| Synergy Research Site | Jackson | Mississippi | United States |
| Synergy Research Site | Port Gibson | Mississippi | United States |
| Synergy Research Site | Chesterfield | Missouri | United States |
| Synergy Research Site | Hazelwood | Missouri | United States |
| Synergy Research Site | St Louis | Missouri | United States |
| Synergy Research Site | Missoula | Montana | United States |
| Synergy Research Site | Omaha | Nebraska | United States |
| Synergy Research Site | Marlton | New Jersey | United States |
| Synergy Research Site | Albuquerque | New Mexico | United States |
| Synergy Research Site | Brooklyn | New York | United States |
| Synergy Research Site | Great Neck | New York | United States |
| Synergy Research Site | Hopewell Junction | New York | United States |
| Synergy Research Site | Kew Gardens | New York | United States |
| Synergy Research Site | New Windsor | New York | United States |
| Synergy Research Site | New York | New York | United States |
| Synergy Research Site | North Massapequa | New York | United States |
| Synergy Research Site | Poughkeepsie | New York | United States |
| Synergy Research Site | Asheboro | North Carolina | United States |
| Synergy Research Site | Cary | North Carolina | United States |
| Synergy Research Site. | Charlotte | North Carolina | United States |
| Synergy Research Site | Charlotte | North Carolina | United States |
| Synergy Research Site | Davidson | North Carolina | United States |
| Synergy Research Site | Fayetteville | North Carolina | United States |
| Synergy Research Site | High Point | North Carolina | United States |
| Synergy Research Site | Jacksonville | North Carolina | United States |
| Synergy Research Site | Kinston | North Carolina | United States |
| Synergy Research Site | Raleigh | North Carolina | United States |
| Synergy Research Site | Salisbury | North Carolina | United States |
| Synergy Research Site | Wilmington | North Carolina | United States |
| Synergy Research Site | Winston-Salem | North Carolina | United States |
| Synergy Research Site | Fargo | North Dakota | United States |
| Synergy Research Site | Beavercreek | Ohio | United States |
| Synergy Research Site | Cincinnati | Ohio | United States |
| Synergy Research Site | Columbus | Ohio | United States |
| Synergy Research Site | Dayton | Ohio | United States |
| Synergy Research Site | Englewood | Ohio | United States |
| Synergy Research Site | Kettering | Ohio | United States |
| Synergy Research Site | Mentor | Ohio | United States |
| Synergy Research Site | Middleburg Heights | Ohio | United States |
| Synergy Research Site | Oklahoma City | Oklahoma | United States |
| Synergy Research Site | Portland | Oregon | United States |
| Synergy Research Site | Lansdale | Pennsylvania | United States |
| Synergy Research Site | Levittown | Pennsylvania | United States |
| Synergy Research Site | Philadelphia | Pennsylvania | United States |
| Synergy Research Site | Smithfield | Pennsylvania | United States |
| Synergy Research Site | Anderson | South Carolina | United States |
| Synergy Research Site | Gaffney | South Carolina | United States |
| Synergy Research Site | Greer | South Carolina | United States |
| Synergy Research Site | Rapid City | South Dakota | United States |
| Synergy Research Site | Athens | Tennessee | United States |
| Synergy Research Site | Chattanooga | Tennessee | United States |
| Synergy Research Site | Fayetteville | Tennessee | United States |
| Synergy Research Site | Franklin | Tennessee | United States |
| Synergy Research Site | Hermitage | Tennessee | United States |
| Synergy Research Site | Jackson | Tennessee | United States |
| Synergy Research Site | Kingsport | Tennessee | United States |
| Synergy Research Site | Knoxville | Tennessee | United States |
| Synergy Research Site | Memphis | Tennessee | United States |
| Synergy Research Site | Nashville | Tennessee | United States |
| Synergy Research Site | Austin | Texas | United States |
| Synergy Research Site | Beaumont | Texas | United States |
| Synergy Research Site | Carrollton | Texas | United States |
| Synergy Research Site | Channelview | Texas | United States |
| Synergy Research Site | Dallas | Texas | United States |
| Synergy Research Site | Houston | Texas | United States |
| Synergy Research Site | Humble | Texas | United States |
| Synergy Research Site | Lampasas | Texas | United States |
| Synergy Research Site | McKinney | Texas | United States |
| Synergy Research Site | Missouri City | Texas | United States |
| Synergy Research Site | Plano | Texas | United States |
| Synergy Research Site | Port Arthur | Texas | United States |
| Synergy Research Site | San Antonio | Texas | United States |
| Synergy Research Site | Sugar Land | Texas | United States |
| Synergy Research Site | Ogden | Utah | United States |
| Synergy Research Site | Orem | Utah | United States |
| Synergy Research Site | Sandy City | Utah | United States |
| Synergy Research Site | St. George | Utah | United States |
| Synergy Research Site | Charlottesville | Virginia | United States |
| Synergy Research Site | Chesapeake | Virginia | United States |
| Synergy Research Site | Fairfax | Virginia | United States |
| Synergy Research Site | Lynchburg | Virginia | United States |
| Synergy Research Site | Newport News | Virginia | United States |
| Synergy Research Site | Norfolk | Virginia | United States |
| Synergy Research Site | Richmond | Virginia | United States |
| Synergy Research Site | Bellevue | Washington | United States |
| Synergy Research Site | Spokane | Washington | United States |
| Synergy Research Site | Charleston | West Virginia | United States |
| Synergy Research Site | Kingwood | West Virginia | United States |
| Synergy Research Site | Morgantown | West Virginia | United States |
| Synergy Research Site | La Crosse | Wisconsin | United States |
| Synergy Research Site | Milwaukee | Wisconsin | United States |
| COMPLETED |
|
| NOT COMPLETED |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Plecanatide | Plecanatide 6.0 mg tablets Plecanatide |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Race (NIH/OMB) | Count of Participants | Participants |
| ||||||||||||||||||
| Body Mass Index | Participants with height and weight information are included. | Mean | Standard Deviation | kilograms per meters squared |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | 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. | Posted | Count of Participants | Participants | up to 53 weeks |
|
|
|
Up to 53 weeks.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Plecanatide | Plecanatide 6.0 mg tablets Plecanatide | 1 | 2,272 | 45 | 2,272 | 341 | 2,272 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Alanine Aminotransferase Increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Aspartate Aminotransferase Increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Liver Function Test Abnormal | Investigations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Transaminases Increased | Investigations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Diverticulitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Bacterial Pyelonephritis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Cellulitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Clostridial Infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Meningitis Viral | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Periorbital Cellulitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pneumonia | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Pyelonephritis Acute | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Subcutaneous Abscess | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Viral Infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Road Traffic Accident | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
| |
| Ankle Fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
| |
| Forearm Fracture | Injury, poisoning and procedural complications | MedDRA (14.1) | Non-systematic Assessment |
| |
| Chronic Obstructive Pulmonary Disease | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Respiratory Failure | Respiratory, thoracic and mediastinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Non-Cardiac Chest Pain | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Chest Pain | General disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Acute Myocardial Infarction | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Angina Unstable | Cardiac disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Leukaemia | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
| |
| Thyroid Cancer | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | MedDRA (14.1) | Non-systematic Assessment |
| |
| Bile Duct Stone | Hepatobiliary disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Cholelithiasis | Hepatobiliary disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Gastric Ulcer | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Back Pain | Musculoskeletal and connective tissue disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Cerebrovascular Accident | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Abortion Spontaneous | Pregnancy, puerperium and perinatal conditions | MedDRA (14.1) | Non-systematic Assessment |
| |
| Anxiety | Psychiatric disorders | MedDRA (14.1) | Non-systematic Assessment |
|
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Diarrhoea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Nausea | Gastrointestinal disorders | MedDRA (14.1) | Non-systematic Assessment |
| |
| Upper Respiratory Tract Infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Urinary Tract Infection | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Nasopharyngitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Sinusitis | Infections and infestations | MedDRA (14.1) | Non-systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA (14.1) | Non-systematic Assessment |
|
Please contact Sponsor directly for additional information.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matt Markovich | Bausch Health | 908-541-1341 | Matthew.Markovich@bauschhealth.com |
| Aug 5, 2020 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C584575 | plecanatide |
Not provided
Not provided
Not provided
|
| Native Hawaiian or Other Pacific Islander |
|
| Black or African American |
|
| White |
|
| More than one race |
|
| Unknown or Not Reported |
|