Chronic Idiopathic Constipation Clinical Trial
Official title:
An Open-Label Extension (OLE), Long-term Safety and Tolerability Study of Plecanatide in Patients With Chronic Idiopathic Constipation (CIC)
| NCT number | NCT01919697 |
| Other study ID # | SP304203-01 |
| Secondary ID | |
| Status | Completed |
| Phase | Phase 3 |
| First received | |
| Last updated | |
| Start date | August 2013 |
| Est. completion date | March 2016 |
| Verified date | June 2019 |
| Source | Bausch Health Americas, Inc. |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in patients with Chronic Idiopathic Constipation (CIC).
| Status | Completed |
| Enrollment | 2370 |
| Est. completion date | March 2016 |
| Est. primary completion date | January 2016 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | 18 Years to 81 Years |
| Eligibility |
Inclusion Criteria: - Patient completed a previous double-blind plecanatide study and was compliant with the study requirements. - Patient is in good health without unstable acute illness or exacerbation of an unstable chronic illness or chronic disease that may affect study assessments, particularly if there has been a significant change to health status since the previous plecanatide study. Exclusion Criteria: - Patient has had major surgery including laparoscopic procedures requiring general anesthesia within 60 days of Day 1. - Patient has a medical history of hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection. - Patient has taken a protocol-prohibited drug without the appropriate washout period. |
| Country | Name | City | State |
|---|---|---|---|
| Canada | Synergy Research Site | Bridgewater | Nova Scotia |
| Canada | Synergy Research Site | Cambridge | Ontario |
| Canada | Synergy Research Site | Kelowna | British Columbia |
| Canada | Synergy Research Site | Mirabel | Quebec |
| Canada | Synergy Research Site | Pointe-Claire | Quebec |
| Canada | Synergy Research Site | St-Romuald | Quebec |
| Canada | Synergy Research Site | Sudbury | Ontario |
| Canada | Synergy Research Site | Toronto | Ontario |
| Canada | Synergy Research Site | Toronto | Ontario |
| United States | Synergy Research Site | Albuquerque | New Mexico |
| United States | Synergy Research Site | Albuquerque | New Mexico |
| United States | Synergy Research Site | Anaheim | California |
| United States | Synergy Research Site | Anaheim | California |
| United States | Synergy Research Site | Anderson | South Carolina |
| United States | Synergy Research Site | Arlington | Texas |
| United States | Synergy Research Site | Artesia | California |
| United States | Synergy Research Site | Athens | Georgia |
| United States | Synergy Research Site | Atlanta | Georgia |
| United States | Synergy Research Site | Augusta | Kansas |
| United States | Synergy Research Site | Austin | Texas |
| United States | Synergy Research Site | Austin | Texas |
| United States | Synergy Research Site | Bastrop | Louisiana |
| United States | Synergy Research Site | Beavercreek | Ohio |
| United States | Synergy Research Site | Biloxi | Mississippi |
| United States | Synergy Research Site | Birmingham | Alabama |
| United States | Synergy Research Site | Blackfoot | Idaho |
| United States | Synergy Research Site | Boston | Massachusetts |
| United States | Synergy Research Site | Boynton Beach | 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 | Brownsburg | Indiana |
| United States | Synergy Research Site | Carlsbad | California |
| United States | Synergy Research Site | Cary | North Carolina |
| United States | Synergy Research Site | Centerville | Ohio |
| United States | Synergy Research Site | Cerritos | California |
| United States | Synergy Research Site | Chandler | Arizona |
| United States | Synergy Research Site | Channelview | Texas |
| United States | Synergy Research Site | Chapel Hill | North Carolina |
| United States | Synergy Research Site | Charleston | South Carolina |
| United States | Synergy Research Site | Charlotte | North Carolina |
| United States | Synergy Research Site | Charlotte | North Carolina |
| United States | Synergy Research Site | Chattanooga | Tennessee |
| United States | Synergy Research Site | Chesterfield | Michigan |
| United States | Synergy Research Site | Chevy Chase | Maryland |
| United States | Synergy Research Site | Chicago | Illinois |
| United States | Synergy Research Site | Christiansburg | Virginia |
| United States | Synergy Research Site | Chula Vista | California |
| United States | Synergy Research Site | Cincinnati | Ohio |
| United States | Synergy Research Site | Cincinnati | Ohio |
| United States | Synergy Research Site | Clearwater | Florida |
| United States | Synergy Research Site | Clearwater | Florida |
| United States | Synergy Research Site | Cleveland | Ohio |
| United States | Synergy Research Site | Clive | Iowa |
| United States | Synergy Research Site | Colorado Springs | Colorado |
| United States | Synergy Research Site | Colorado Springs | Colorado |
| United States | Synergy Research Site | Colorado Springs | Colorado |
| United States | Synergy Research Site | Columbia | South Carolina |
| United States | Synergy Research Site | Corona | California |
| United States | Synergy Research Site | Cutler Bay | Florida |
| United States | Synergy Research Site | Dallas | Texas |
| United States | Synergy Research Site | Dallas | Texas |
| United States | Synergy Research Site | Decatur | Georgia |
| United States | Synergy Research Site | Decatur | Georgia |
| United States | Synergy Research Site | DeLand | Florida |
| United States | Synergy Research Site | Denver | Colorado |
| United States | Synergy Research Site | Denver | Colorado |
| United States | Synergy Research Site | Denver | Colorado |
| United States | Synergy Research Site | Dothan | Alabama |
| United States | Synergy Research Site | Elizabeth | New Jersey |
| United States | Synergy Research Site | Encinitas | California |
| United States | Synergy Research Site | Fargo | North Dakota |
| United States | Synergy Research Site | Flint | Michigan |
| 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 | Fresno | California |
| United States | Synergy Research Site | Grand Island | Nebraska |
| United States | Synergy Research Site | Great Neck | New York |
| United States | Synergy Research Site | Greensboro | North Carolina |
| United States | Synergy Research Site | Gulf Shores | Alabama |
| United States | Synergy Research Site | Hawaiian Gardens | California |
| United States | Synergy Research Site | Henderson | Nevada |
| United States | Synergy Research Site | Henrico | Virginia |
| United States | Synergy Research Site | Hialeah | Florida |
| United States | Synergy Research Site | Hialeah | Florida |
| United States | Synergy Research Site | Hialeah | Florida |
| United States | Synergy Research Site | Homestead | Florida |
| United States | Synergy Research Site | Houston | Texas |
| United States | Synergy Research Site | Houston | Texas |
| United States | Synergy Research Site | Houston | Texas |
| United States | Synergy Research Site | Houston | Texas |
| United States | Synergy Research Site | Houston | Texas |
| United States | Synergy Research Site | Houston | Texas |
| United States | Synergy Research Site | Huber Heights | Ohio |
| United States | Synergy Research Site | Humble | Texas |
| United States | Synergy Research Site | Huntsville | Alabama |
| United States | Synergy Research Site | Jackson | Tennessee |
| United States | Synergy Research Site | Jackson | Mississippi |
| United States | Synergy Research Site | Jupiter | Florida |
| United States | Synergy Research Site | Katy | Texas |
| United States | Synergy Research Site | Kinston | North Carolina |
| United States | Synergy Research Site | Knoxville | Tennessee |
| United States | Synergy Research Site | La Mirada | California |
| United States | Synergy Research Site | Laguna Hills | California |
| United States | Synergy Research Site | Lakeland | Florida |
| United States | Synergy Research Site | Lancaster | California |
| United States | Synergy Research Site | Las Vegas | Nevada |
| United States | Synergy Research Site | Las Vegas | Nevada |
| United States | Synergy Research Site | Las Vegas | Nevada |
| United States | Synergy Research Site | Levittown | Pennsylvania |
| United States | Synergy Research Site | Lexington | Kentucky |
| United States | Synergy Research Site | Limerick | Pennsylvania |
| United States | Synergy Research Site | Little Rock | Arkansas |
| United States | Synergy Research Site | Littleton | Colorado |
| United States | Synergy Research Site | Lodi | New Jersey |
| United States | Synergy Research Site | Logan | Utah |
| United States | Synergy Research Site | Long Beach | California |
| United States | Synergy Research Site | Los Angeles | California |
| United States | Synergy Research Site | Los Angeles | California |
| United States | Synergy Research Site | Lynchburg | Virginia |
| United States | Synergy Research Site | Marlton | New Jersey |
| United States | Synergy Research Site | Marrero | Louisiana |
| United States | Synergy Research Site | Maumee | Ohio |
| United States | Synergy Research Site | Memphis | Tennessee |
| United States | Synergy Research Site | Mentor | Ohio |
| United States | Synergy Research Site | Metairie | Louisiana |
| United States | Synergy Research Site | Miami | Florida |
| United States | Synergy Research Site | Miami | Florida |
| United States | Synergy Research Site | Miami | Florida |
| United States | Synergy Research Site | Miami | Florida |
| United States | Synergy Research Site | Miami | Florida |
| United States | Synergy Research Site | Miami | Florida |
| United States | Synergy Research Site | Miami | Florida |
| United States | Synergy Research Site | Miami | Florida |
| United States | Synergy Research Site | Miami | Florida |
| United States | Synergy Research Site | Miami | Florida |
| United States | Synergy Research Site | Miami | Florida |
| United States | Synergy Research Site | Miami | Florida |
| United States | Synergy Research Site | Miami | Florida |
| United States | Synergy Research Site | Miami | 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 | Mission Hills | California |
| United States | Synergy Research Site | Nashville | Tennessee |
| United States | Synergy Research Site | New Bedford | Massachusetts |
| United States | Synergy Research Site | New Orleans | Louisiana |
| United States | Synergy Research Site | New Orleans | Louisiana |
| United States | Synergy Research Site | New Tazewell | Tennessee |
| United States | Synergy Research Site | New York | New York |
| United States | Synergy Research Site | Newport News | Virginia |
| United States | Synergy Research Site | Newton | Kansas |
| United States | Synergy Research Site | Norfolk | Virginia |
| United States | Synergy Research Site | Norfolk | Virginia |
| United States | Synergy Research Site | Norman | Oklahoma |
| United States | Synergy Research Site | North Hollywood | California |
| United States | Synergy Research Site | North Little Rock | Arkansas |
| United States | Synergy Research Site | Oakwood | Georgia |
| United States | Synergy Research Site | Oakwood | Ohio |
| United States | Synergy Research Site | Oklahoma City | Oklahoma |
| 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 | Orlando | Florida |
| United States | Synergy Research Site | Orlando | Florida |
| United States | Synergy Research Site | Orlando | Florida |
| United States | Synergy Research Site | Owensboro | Kentucky |
| United States | Synergy Research Site | Pasadena | California |
| 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 | Pittsburgh | Pennsylvania |
| United States | Synergy Research Site | Plano | Texas |
| United States | Synergy Research Site | Port Orange | Florida |
| United States | Synergy Research Site | Poughkeepsie | New York |
| United States | Synergy Research Site | Raleigh | North Carolina |
| United States | Synergy Research Site | Reno | Nevada |
| United States | Synergy Research Site | Richland | Washington |
| United States | Synergy Research Site | Richmond | Virginia |
| United States | Synergy Research Site | Rochester | Michigan |
| United States | Synergy Research Site | Sacramento | California |
| United States | Synergy Research Site | Saginaw | Michigan |
| 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 | Salt Lake City | Utah |
| United States | Synergy Research Site | San Antonio | Texas |
| United States | Synergy Research Site | San Antonio | Texas |
| United States | Synergy Research Site | San Diego | California |
| United States | Synergy Research Site | San Diego | California |
| United States | Synergy Research Site | San Diego | California |
| United States | Synergy Research Site | Sandy Springs | Georgia |
| United States | Synergy Research Site | Savannah | Georgia |
| United States | Synergy Research Site | Seattle | Washington |
| United States | Synergy Research Site | Shawnee Mission | Kansas |
| United States | Synergy Research Site | Shreveport | Louisiana |
| United States | Synergy Research Site | Smyrna | Georgia |
| United States | Synergy Research Site | Snellville | Georgia |
| United States | Synergy Research Site | Southfield | Michigan |
| United States | Synergy Research Site | Stow | Ohio |
| United States | Synergy Research Site | Sugar Land | Texas |
| United States | Synergy Research Site | Tacoma | Washington |
| United States | Synergy Research Site | Tamarac | Florida |
| United States | Synergy Research Site | Tampa | Florida |
| United States | Synergy Research Site | Tampa | Florida |
| United States | Synergy Research Site | Tempe | Arizona |
| United States | Synergy Research Site | Thousand Oaks | California |
| United States | Synergy Research Site | Tucson | Arizona |
| United States | Synergy Research Site | Tucson | Arizona |
| United States | Synergy Research Site | Tucson | Arizona |
| United States | Synergy Research Site | Waterbury | Connecticut |
| United States | Synergy Research Site | Wauwatosa | Wisconsin |
| United States | Synergy Research Site | West Jordan | Utah |
| United States | Synergy Research Site | West Palm Beach | Florida |
| United States | Synergy Research Site | Wichita | Kansas |
| 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 | Yardley | Pennsylvania |
| Lead Sponsor | Collaborator |
|---|---|
| Bausch Health Americas, Inc. | Syneos Health |
United States, Canada,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) | All clinically significant findings upon Physical Examinations of the Safety Population during the treatment period were reported as TEAEs. Safety was evaluated based on number of patients who experienced at least one TEAE. | From first dose up to 72 weeks | |
| Primary | Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide | Tolerability was evaluated based on number of patients who experienced at least one TEAE leading to discontinuation of the study drug | From first dose up to 72 weeks | |
| Primary | Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg) | The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute). | From first dose up to 72 weeks | |
| Primary | Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute) | The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute). | From first dose up to 72 weeks | |
| Primary | Summary of Vital Signs at >Day 364 - Body Temperature (°C) | The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute). | From first dose up to 72 weeks | |
| Primary | Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute) | The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute). | From first dose up to 72 weeks | |
| Primary | Summary of ECG Results Shift From Baseline at > Day 364 | Baseline was defined as the last non-missing value collected prior to first dose of study drug) | From first dose up to 72 weeks | |
| Primary | Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline | Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. The Common Terminology Criteria for Adverse Events (CTCAE), Grades 1 through 5 were used for descriptions of severity for each Adverse Event (AE): Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 - Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental Activities of Daily Living (ADL); Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 - Life-threatening consequences; urgent intervention indicated; Grade 5 - Death related to AE. | From first dose up to 72 weeks | |
| Secondary | Summary of Patient Patient Global Assessment (PGA) for Constipation Severity at > Day 364 | Constipation severity was measured using a 5-point score: 1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Very severe Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. | Form first dose up to 72 weeks | |
| Secondary | Summary of Patient Global Assessment (PGA) for Constipation - Change From Baseline to > Day 364 | Change of Constipation measured using a 7-point score: 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No change, 5=Minimally Worse, 6=Much Worse, 7=Very Much Worse Baseline is defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. | From first dose up to 72 weeks | |
| Secondary | Summary of Patient Global Assessment (PGA) for Treatment Satisfaction at > Day 364 | Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. Treatment Satisfaction was measured using a 5-point score: 1=Not At All Satisfied, 2=A Little Satisfied, 3=Moderately Satisfied, 4=Quite Satisfied, 5=Very Satisfied. | From first dose up to 72 weeks | |
| Secondary | Summary of Patient Global Assessment (PGA) for Treatment Continuation at End of Treatment | Treatment continuation was measured using 5-point score: 1=Not At All Likely, 2=A Little Likely, 3=Moderately Likely, 4=Quite Likely, 5=Very Likely | From first dose up to 72 weeks |
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