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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02387359
Other study ID # SP304203-04
Secondary ID
Status Completed
Phase Phase 3
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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