Irritable Bowel Syndrome Characterized by Constipation Clinical Trial
— IBS-COfficial title:
A Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Verified date | June 2019 |
Source | Bausch Health Americas, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.
Status | Completed |
Enrollment | 1054 |
Est. completion date | February 2017 |
Est. primary completion date | December 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
Inclusion Criteria: •Adult patients between the ages of 18 and 85 years (inclusive) with a diagnosis of IBS based on ROME III diagnostic criteria and meeting criteria for diagnosis of the constipation predominant subtype - IBS-C Exclusion Criteria: - Refusal or inability to sign informed consent for the trial - Refusal or inability to complete daily Episodic (real-time) BM / RM calls, End of Day daily Calls, and/or complete electronic questionnaires - BMI > 35 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 |
Country | Name | City | State |
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United States | Synergy Research Site | Albuquerque | New Mexico |
United States | Synergy Research Site | Alexandria | Virginia |
United States | Synergy Research Site | Anaheim | California |
United States | Synergy Research Site | Arlington | Texas |
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 | Augusta | Kansas |
United States | Synergy Research Site | Austin | Texas |
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 | Beavercreek | Ohio |
United States | Synergy Research Site | Bellevue | Washington |
United States | Synergy Research Site | Birmingham | Alabama |
United States | Synergy Research Site | Boston | Massachusetts |
United States | Synergy Research Site | Bountiful | Utah |
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 | Broomfield | Colorado |
United States | Synergy Research Site | Carrollton | Texas |
United States | Synergy Research Site | Cary | North Carolina |
United States | Synergy Research Site. | Centennial | Colorado |
United States | Synergy Research Site | Chandler | Arizona |
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 | Chesterfield | Michigan |
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 | Cleveland | Ohio |
United States | Synergy Research Site | Cleveland | Ohio |
United States | Synergy Research Site | Columbia | South Carolina |
United States | Synergy Research Site | Concord | North Carolina |
United States | Synergy Research Site | Conway | Arkansas |
United States | Synergy Research Site | Corona | California |
United States | Synergy Research Site | Crowley | Louisiana |
United States | Synergy Research Site | Dallas | Texas |
United States | Synergy Research Site | Davidson | North Carolina |
United States | Synergy Research Site | DeLand | Florida |
United States | Synergy Research Site | Dothan | Alabama |
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 | Evansville | Indiana |
United States | Synergy Research Site | Evergreen Park | Illinois |
United States | Synergy Research Site | Fargo | North Dakota |
United States | Synergy Research Site | Flint | Michigan |
United States | Synergy Research Site | Foley | Alabama |
United States | Synergy Research Site | Fort Lauderdale | Florida |
United States | Synergy Research Site | Fountain Valley | California |
United States | Synergy Research Site | Fresno | California |
United States | Synergy Research Site | Gaffney | South Carolina |
United States | Synergy Research Site | Garden Grove | California |
United States | Synergy Research Site | Glendale | Arizona |
United States | Synergy Research Site | Great Neck | New York |
United States | Synergy Research Site | Greensboro | North Carolina |
United States | Synergy Research Site. | Greer | South Carolina |
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 | Homestead | Florida |
United States | Synergy Research Site | Houston | Texas |
United States | Synergy Research Site | Houston | Texas |
United States | Synergy Research Site | Huntsville | Alabama |
United States | Synergy Research Site | Idaho Falls | Idaho |
United States | Synergy Research Site | Idaho Falls | Idaho |
United States | Synergy Research Site | Inverness | Florida |
United States | Synergy Research Site. | Jackson | Mississippi |
United States | Synergy Research Site | Jacksonville | Florida |
United States | Synergy Research Site | Kinston | North Carolina |
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 | Las Vegas | Nevada |
United States | Synergy Research Site | Lenoir | North Carolina |
United States | Synergy Research Site | Levittown | Pennsylvania |
United States | Synergy Research Site | Little Rock | Arkansas |
United States | Synergy Research Site | Little Rock | Arkansas |
United States | Synergy Research Site | Lynchburg | Virginia |
United States | Synergy Research Site | Mandeville | Louisiana |
United States | Synergy Research Site | Marietta | Georgia |
United States | Synergy Research Site | Marlton | New Jersey |
United States | Synergy Research Site | Memphis | Tennessee |
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 | Milwaukee | Wisconsin |
United States | Synergy Research Site | Monroe | Louisiana |
United States | Synergy Research Site | Montgomery | Alabama |
United States | Synergy Research Site | Morgantown | West Virginia |
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 | Newton | Kansas |
United States | Synergy Research Site | Norcross | Georgia |
United States | Synergy Research Site | Norcross | Georgia |
United States | Synergy Research Site | North Charleston | South Carolina |
United States | Synergy Research Site | North Hollywood | California |
United States | Synergy Research Site | North Massapequa | New York |
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 | Orlando | Florida |
United States | Synergy Research Site | Ormond Beach | Florida |
United States | Synergy Research Site | Oviedo | 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 | Portland | Oregon |
United States | Synergy Research Site | Raleigh | North Carolina |
United States | Synergy Research Site | Rapid City | South Dakota |
United States | Synergy Research Site | Rochester | Michigan |
United States | Synergy Research Site | Rockford | Illinois |
United States | Synergy Research Site | Sacramento | California |
United States | Synergy Research Site | Saint George | Utah |
United States | Synergy Research Site | Saint Petersburg | Florida |
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 | Sandy | Utah |
United States | Synergy Research Site | Shreveport | Louisiana |
United States | Synergy Research Site | Smithfield | Pennsylvania |
United States | Synergy Research Site | Spokane | Washington |
United States | Synergy Research Site | Stockbridge | Georgia |
United States | Synergy Research Site | Sylvania | Ohio |
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 | Tucson | Arizona |
United States | Synergy Research Site | Tulsa | Oklahoma |
United States | Synergy Research Site | Uniontown | Pennsylvania |
United States | Synergy Research Site | Upland | California |
United States | Synergy Research Site | Upland | California |
United States | Synergy Research Site | Wauwatosa | Wisconsin |
United States | Synergy Research Site | Webster | Texas |
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 | Wyoming | Michigan |
Lead Sponsor | Collaborator |
---|---|
Bausch Health Americas, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Number of Overall Responders - ITT Population | An Overall Responder was a patient who was a Weekly Responder (i.e., decrease of 30% from baseline for abdominal pain intensity and an increase of at least one complete spontaneous bowel movement in the same week) for at least 6 of the 12 treatment weeks. | 12 Weeks | |
Primary | Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks | An Abdominal Pain Intensity Responder was a patient who had a decrease of 30% from baseline for abdominal pain intensity. Baseline was the mean of non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. | 12 Weeks | |
Primary | Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks | A Stool Frequency Responder is defined as a patient who experienced an increase of at least one CSBM (complete spontaneous bowel movement) per week from baseline. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. | 12 weeks | |
Secondary | Number of Sustained Efficacy Responders | A Sustained Efficacy Responder was a patient who was an Overall Responder who also was a Weekly Responder, i.e., decreased of 30% from baseline for abdominal pain intensity and increased of at least one CSBM (complete spontaneous bowel movement) in the same week for at least 2 of the 4 weeks in month 3 of the Treatment Period. | 12 weeks | |
Secondary | Change From Baseline in Stool Consistency | Change from baseline in stool consistency based upon the Bristol Stool Form Scale (BSFS) Rating 1 to 7. Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. BSFS Rating 1 to 7: Separate hard lumps, like nuts (hard to pass) Sausage-shaped but lumpy Like a sausage but with cracks on its surface Like a sausage or snake, smooth and soft Soft blobs with clear-cut edges (passed easily) Fluffy pieces with ragged edges, a mushy stool Watery, no solid pieces, entirely liquid |
Baseline and 12-Week | |
Secondary | Change From Baseline in Straining | Change from baseline in Straining Score over the 12-week treatment period. Baseline was the mean of non-missing straining scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The severity of straining during a bowel movement was measured using an 11-point scale (0-10 rating; 0 = no straining; 10 = worst straining). | Baseline and 12-week | |
Secondary | Change From Baseline in CSBM Frequency Rate | Change from baseline over the 12-week Treatment Period in CSBM (Complete Spontaneous Bowel Movement) Frequency Rate (CSBMs/Week). Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. | Baseline and 12-Week | |
Secondary | Number of Patients With a SBM Within 24 Hours After the First Dose | Number of patients with a SBM (spontaneous bowel movement) within 24 hours after the first dose of study drug | Up to 24 hours after first dose of study drug | |
Secondary | Change From Baseline in Abdominal Pain | Change from baseline in abdominal pain as measured with an 11-point (0-10) Numerical Rating Scale from 0 (No) to 10 (Worst Possible). Baseline is the mean of non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. | Baseline and 12-Week |
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