Irritable Bowel Syndrome Clinical Trial
— IBS-COfficial title:
An Open Label, Long Term Safety and Tolerability Study of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
| NCT number | NCT02706483 |
| Other study ID # | SP304203-06 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | January 2016 |
| Est. completion date | June 2017 |
| Verified date | August 2020 |
| Source | Bausch Health Americas, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
Multi-center, open-label, long-term safety study
| Status | Completed |
| Enrollment | 2272 |
| Est. completion date | June 2017 |
| Est. primary completion date | May 2017 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 85 Years |
| Eligibility |
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. Key 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. |
| Country | Name | City | State |
|---|---|---|---|
| United States | Synergy Research Site | Albuquerque | New Mexico |
| United States | Synergy Research Site | Anderson | South Carolina |
| United States | Synergy Research Site | Annapolis | Maryland |
| United States | Synergy Research Site | Artesia | California |
| United States | Synergy Research Site | Asheboro | North Carolina |
| United States | Synergy Research Site | Athens | Tennessee |
| United States | Synergy Research Site | Athens | Alabama |
| United States | Synergy Research Site | Atlanta | Georgia |
| United States | Synergy Research Site | Atlantis | Florida |
| United States | Synergy Research Site | Austin | Texas |
| United States | Synergy Research Site | Baltimore | Maryland |
| United States | Synergy Research Site | Baton Rouge | Louisiana |
| United States | Synergy Research Site | Beaumont | Texas |
| United States | Synergy Research Site | Beavercreek | Ohio |
| United States | Synergy Research Site | Bellevue | Washington |
| United States | Synergy Research Site | Birmingham | Alabama |
| United States | Synergy Research Site | Blackfoot | Idaho |
| United States | Synergy Research Site | Blue Island | Illinois |
| United States | Synergy Research Site | Boca Raton | Florida |
| United States | Synergy Research Site | Boise | Idaho |
| 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 | Bristol | Connecticut |
| United States | Synergy Research Site | Brooklyn | New York |
| United States | Synergy Research Site | Brooksville | Florida |
| United States | Synergy Research Site | Brownsburg | Indiana |
| United States | Synergy Research Site | Canoga Park | California |
| United States | Synergy Research Site | Carmichael | California |
| United States | Synergy Research Site | Carrollton | Texas |
| United States | Synergy Research Site | Cary | North Carolina |
| United States | Synergy Research Site | Chandler | Arizona |
| United States | Synergy Research Site | Channelview | Texas |
| United States | Synergy Research Site | Charleston | West Virginia |
| United States | Synergy Research Site | Charlotte | North Carolina |
| United States | Synergy Research Site. | Charlotte | North Carolina |
| United States | Synergy Research Site | Charlottesville | Virginia |
| United States | Synergy Research Site | Chattanooga | Tennessee |
| United States | Synergy Research Site | Chesapeake | Virginia |
| United States | Synergy Research Site | Chesterfield | Michigan |
| United States | Synergy Research Site | Chesterfield | Missouri |
| United States | Synergy Research Site | Chicago | Illinois |
| United States | Synergy Research Site | Chula Vista | California |
| United States | Synergy Research Site | Cincinnati | Ohio |
| United States | Synergy Research Site | Clearwater | Florida |
| United States | Synergy Research Site | Colorado Springs | Colorado |
| United States | Synergy Research Site | Columbus | Ohio |
| United States | Synergy Research Site | Conway | Arkansas |
| United States | Synergy Research Site | Corona | California |
| United States | Synergy Research Site | Costa Mesa | California |
| United States | Synergy Research Site | Crowley | Louisiana |
| United States | Synergy Research Site | Cutler Bay | Florida |
| United States | Synergy Research Site | Dallas | Texas |
| United States | Synergy Research Site | Davidson | North Carolina |
| United States | Synergy Research Site | Dayton | Ohio |
| United States | Synergy Research Site | DeLand | Florida |
| United States | Synergy Research Site | Denver | Colorado |
| United States | Synergy Research Site | Dothan | Alabama |
| United States | Synergy Research Site | El Cajon | California |
| United States | Synergy Research Site | Encino | California |
| United States | Synergy Research Site | Englewood | Ohio |
| United States | Synergy Research Site | Evanston | Illinois |
| United States | Synergy Research Site | Evergreen Park | Illinois |
| United States | Synergy Research Site | Fairfax | Virginia |
| United States | Synergy Research Site | Fargo | North Dakota |
| United States | Synergy Research Site | Fayetteville | North Carolina |
| United States | Synergy Research Site | Fayetteville | Tennessee |
| United States | Synergy Research Site | Flint | Michigan |
| United States | Synergy Research Site | Foley | Alabama |
| United States | Synergy Research Site | Foothill Ranch | California |
| United States | Synergy Research Site | Fort Lauderdale | Florida |
| United States | Synergy Research Site | Fountain Valley | California |
| United States | Synergy Research Site | Franklin | Tennessee |
| United States | Synergy Research Site | Gaffney | South Carolina |
| United States | Synergy Research Site | Garden Grove | California |
| United States | Synergy Research Site | Glendale | Arkansas |
| United States | Synergy Research Site | Great Neck | New York |
| United States | Synergy Research Site | Greer | South Carolina |
| United States | Synergy Research Site | Guntersville | Alabama |
| United States | Synergy Research Site | Hagerstown | Maryland |
| United States | Synergy Research Site | Hamden | Connecticut |
| United States | Synergy Research Site | Hazelwood | Missouri |
| United States | Synergy Research Site | Hermitage | Tennessee |
| United States | Synergy Research Site | Hialeah | Florida |
| United States | Synergy Research Site | High Point | North Carolina |
| United States | Synergy Research Site | Hoffman Estates | Illinois |
| United States | Synergy Research Site | Homestead | Florida |
| United States | Synergy Research Site | Hopewell Junction | New York |
| United States | Synergy Research Site | Houston | Texas |
| United States | Synergy Research Site | Humble | Texas |
| United States | Synergy Research Site | Huntington Beach | California |
| United States | Synergy Research Site | Huntsville | Alabama |
| United States | Synergy Research Site | Indianapolis | Indiana |
| United States | Synergy Research Site | Inverness | Florida |
| United States | Synergy Research Site | Jackson | Mississippi |
| United States | Synergy Research Site | Jackson | Tennessee |
| United States | Synergy Research Site | Jacksonville | North Carolina |
| United States | Synergy Research Site | Jacksonville | Florida |
| United States | Synergy Research Site | Kettering | Ohio |
| United States | Synergy Research Site | Kew Gardens | New York |
| United States | Synergy Research Site | Kingsport | Tennessee |
| United States | Synergy Research Site | Kingwood | West Virginia |
| United States | Synergy Research Site | Kinston | North Carolina |
| United States | Synergy Research Site | Knoxville | Tennessee |
| United States | Synergy Research Site | La Crosse | Wisconsin |
| United States | Synergy Research Site | La Mesa | California |
| United States | Synergy Research Site | La Mirada | California |
| United States | Synergy Research Site | Lafayette | Colorado |
| United States | Synergy Research Site | Laguna Hills | California |
| United States | Synergy Research Site | Lampasas | Texas |
| United States | Synergy Research Site | Lancaster | California |
| United States | Synergy Research Site | Lansdale | Pennsylvania |
| United States | Synergy Research Site | Lauderdale Lakes | Florida |
| United States | Synergy Research Site | Levittown | Pennsylvania |
| United States | Synergy Research Site | Little Rock | Arkansas |
| 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 | Lynchburg | Virginia |
| United States | Synergy Research Site | Madisonville | Kentucky |
| United States | Synergy Research Site | Mandeville | Louisiana |
| United States | Synergy Research Site | Marietta | Georgia |
| United States | Synergy Research Site | Marlborough | Massachusetts |
| United States | Synergy Research Site | Marlton | New Jersey |
| United States | Synergy Research Site | Marrero | Louisiana |
| United States | Synergy Research Site | McKinney | Texas |
| United States | Synergy Research Site | Memphis | Tennessee |
| United States | Synergy Research Site | Mentor | Ohio |
| United States | Synergy Research Site | Meridian | Idaho |
| United States | Synergy Research Site | Metairie | Louisiana |
| 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 | Middleburg Heights | Ohio |
| United States | Synergy Research Site | Milwaukee | Wisconsin |
| United States | Synergy Research Site | Missoula | Montana |
| United States | Synergy Research Site | Missouri City | Texas |
| United States | Synergy Research Site | Morgantown | West Virginia |
| United States | Synergy Research Site | Morton | Illinois |
| United States | Synergy Research Site | Naples | Florida |
| United States | Synergy Research Site | Nashville | Tennessee |
| United States | Synergy Research Site | New Orleans | Louisiana |
| United States | Synergy Research Site | New Windsor | New York |
| United States | Synergy Research Site | New York | New York |
| United States | Synergy Research Site | Newport News | Virginia |
| United States | Synergy Research Site | Norfolk | Virginia |
| United States | Synergy Research Site | North Hollywood | California |
| United States | Synergy Research Site | North Massapequa | New York |
| United States | Synergy Research Site | North Miami Beach | Florida |
| United States | Synergy Research Site | Northridge | California |
| United States | Synergy Research Site | Oak Lawn | Illinois |
| United States | Synergy Research Site | Ogden | Utah |
| United States | Synergy Research Site | Oklahoma City | Oklahoma |
| United States | Synergy Research Site | Omaha | Nebraska |
| United States | Synergy Research Site | Orange | California |
| United States | Synergy Research Site | Orange Park | Florida |
| United States | Synergy Research Site | Orem | Utah |
| 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 | Owensboro | Kentucky |
| United States | Synergy Research Site | Oxon Hill | Maryland |
| United States | Synergy Research Site | Pembroke Pines | Florida |
| United States | Synergy Research Site | Philadelphia | Pennsylvania |
| United States | Synergy Research Site | Phoenix | Arizona |
| United States | Synergy Research Site | Pinellas Park | Florida |
| United States | Synergy Research Site | Placentia | California |
| United States | Synergy Research Site | Plano | Texas |
| United States | Synergy Research Site | Port Arthur | Texas |
| United States | Synergy Research Site | Port Gibson | Mississippi |
| United States | Synergy Research Site | Port Orange | Florida |
| United States | Synergy Research Site | Portland | Oregon |
| United States | Synergy Research Site | Poughkeepsie | New York |
| United States | Synergy Research Site | Raleigh | North Carolina |
| United States | Synergy Research Site | Rapid City | South Dakota |
| United States | Synergy Research Site | Richmond | Virginia |
| United States | Synergy Research Site | Riverside | California |
| United States | Synergy Research Site | Saint George | Utah |
| United States | Synergy Research Site | Saint Louis | Missouri |
| United States | Synergy Research Site | Saint Petersburg | Florida |
| United States | Synergy Research Site | Salisbury | North Carolina |
| United States | Synergy Research Site | San Antonio | Texas |
| 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 | Sandy | Utah |
| United States | Synergy Research Site | Saraland | Alabama |
| United States | Synergy Research Site | Schaumburg | Illinois |
| United States | Synergy Research Site | Sherman Oaks | California |
| United States | Synergy Research Site | Shreveport | Louisiana |
| United States | Synergy Research Site | Smithfield | Pennsylvania |
| United States | Synergy Research Site | Snellville | Georgia |
| United States | Synergy Research Site | Spokane | Washington |
| United States | Synergy Research Site | Sugar Land | Texas |
| United States | Synergy Research Site | Surprise | Arizona |
| United States | Synergy Research Site | Tamarac | Florida |
| United States | Synergy Research Site | Tampa | Florida |
| United States | Synergy Research Site | Thousand Oaks | California |
| United States | Synergy Research Site | Topeka | Kansas |
| United States | Synergy Research Site | Tucson | Arizona |
| United States | Synergy Research Site | Wichita | Kansas |
| United States | Synergy Research Site | Wilmington | North Carolina |
| United States | Synergy Research Site | Winston-Salem | North Carolina |
| United States | Synergy Research Site | Wyoming | Michigan |
| Lead Sponsor | Collaborator |
|---|---|
| Bausch Health Americas, Inc. |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| 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. | up to 53 weeks |
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