The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)

Irritable Bowel Syndrome Characterized by Constipation Clinical Trial

— IBS-C  

Official 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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02387359
• Other study ID #: SP304203-04
• Status: Completed
• Phase: Phase 3
• Start date: December 2014
• Est. completion date: February 2017

Study information

• Verified date: June 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Constipation
• Irritable Bowel Syndrome
• Irritable Bowel Syndrome Characterized by Constipation
• Syndrome

Intervention

Drug:
• Plecanatide

• Placebo

Locations

Country	Name	City	State
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

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

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