Clinical trial NCT02387359: The Plecanatide Irritable Bowel Syndrome With Constipation Study (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)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irritable Bowel Syndrome Characterized by Constipation
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2015-03-13
Enrollment: 1054
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Overall Responders - ITT Population
timeFrame: 12 Weeks
measure: Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks
timeFrame: 12 Weeks
measure: Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks
timeFrame: 12 weeks
Secondary outcomes:
measure: Number of Sustained Efficacy Responders
timeFrame: 12 weeks
measure: Change From Baseline in Stool Consistency
timeFrame: Baseline and 12-Week
measure: Change From Baseline in Straining
timeFrame: Baseline and 12-week
measure: Change From Baseline in CSBM Frequency Rate
timeFrame: Baseline and 12-Week
measure: Number of Patients With a SBM Within 24 Hours After the First Dose
timeFrame: Up to 24 hours after first dose of study drug
measure: Change From Baseline in Abdominal Pain
timeFrame: Baseline and 12-Week
Other outcomes:
Locations:
city: Athens
country: United States
facility: Synergy Research Site
state: Alabama
city: Birmingham
country: United States
facility: Synergy Research Site
state: Alabama
city: Dothan
country: United States
facility: Synergy Research Site
state: Alabama
city: Foley
country: United States
facility: Synergy Research Site
state: Alabama
city: Huntsville
country: United States
facility: Synergy Research Site
state: Alabama
city: Montgomery
country: United States
facility: Synergy Research Site
state: Alabama
city: Chandler
country: United States
facility: Synergy Research Site
state: Arizona
city: Glendale
country: United States
facility: Synergy Research Site
state: Arizona
city: Phoenix
country: United States
facility: Synergy Research Site
state: Arizona
city: Tucson
country: United States
facility: Synergy Research Site
state: Arizona
city: Tucson
country: United States
facility: Synergy Research Site
state: Arizona
city: Conway
country: United States
facility: Synergy Research Site
state: Arkansas
city: Little Rock
country: United States
facility: Synergy Research Site
state: Arkansas
city: Little Rock
country: United States
facility: Synergy Research Site
state: Arkansas
city: Anaheim
country: United States
facility: Synergy Research Site
state: California
city: Artesia
country: United States
facility: Synergy Research Site
state: California
city: Chula Vista
country: United States
facility: Synergy Research Site
state: California
city: Corona
country: United States
facility: Synergy Research Site
state: California
city: Encino
country: United States
facility: Synergy Research Site
state: California
city: Fountain Valley
country: United States
facility: Synergy Research Site
state: California
city: Fresno
country: United States
facility: Synergy Research Site
state: California
city: Garden Grove
country: United States
facility: Synergy Research Site
state: California
city: La Mesa
country: United States
facility: Synergy Research Site
state: California
city: La Mirada
country: United States
facility: Synergy Research Site
state: California
city: Laguna Hills
country: United States
facility: Synergy Research Site
state: California
city: Lancaster
country: United States
facility: Synergy Research Site
state: California
city: North Hollywood
country: United States
facility: Synergy Research Site
state: California
city: Sacramento
country: United States
facility: Synergy Research Site
state: California
city: San Bernardino
country: United States
facility: Synergy Research Site
state: California
city: San Diego
country: United States
facility: Synergy Research Site
state: California
city: Thousand Oaks
country: United States
facility: Synergy Research Site
state: California
city: Upland
country: United States
facility: Synergy Research Site
state: California
city: Upland
country: United States
facility: Synergy Research Site
state: California
city: Broomfield
country: United States
facility: Synergy Research Site
state: Colorado
city: Centennial
country: United States
facility: Synergy Research Site.
state: Colorado
city: Bristol
country: United States
facility: Synergy Research Site
state: Connecticut
city: Hamden
country: United States
facility: Synergy Research Site
state: Connecticut
city: Boynton Beach
country: United States
facility: Synergy Research Site
state: Florida
city: Brandon
country: United States
facility: Synergy Research Site
state: Florida
city: DeLand
country: United States
facility: Synergy Research Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Synergy Research Site
state: Florida
city: Homestead
country: United States
facility: Synergy Research Site
state: Florida
city: Inverness
country: United States
facility: Synergy Research Site
state: Florida
city: Jacksonville
country: United States
facility: Synergy Research Site
state: Florida
city: Miami Lakes
country: United States
facility: Synergy Research Site
state: Florida
city: Miami Springs
country: United States
facility: Synergy Research Site
state: Florida
city: Miami
country: United States
facility: Synergy Research Site
state: Florida
city: Orlando
country: United States
facility: Synergy Research Site
state: Florida
city: Ormond Beach
country: United States
facility: Synergy Research Site
state: Florida
city: Oviedo
country: United States
facility: Synergy Research Site
state: Florida
city: Port Orange
country: United States
facility: Synergy Research Site
state: Florida
city: Saint Petersburg
country: United States
facility: Synergy Research Site
state: Florida
city: Tampa
country: United States
facility: Synergy Research Site
state: Florida
city: Atlanta
country: United States
facility: Synergy Research Site
state: Georgia
city: Marietta
country: United States
facility: Synergy Research Site
state: Georgia
city: Norcross
country: United States
facility: Synergy Research Site
state: Georgia
city: Norcross
country: United States
facility: Synergy Research Site
state: Georgia
city: Stockbridge
country: United States
facility: Synergy Research Site
state: Georgia
city: Idaho Falls
country: United States
facility: Synergy Research Site
state: Idaho
city: Idaho Falls
country: United States
facility: Synergy Research Site
state: Idaho
city: Chicago
country: United States
facility: Synergy Research Site
state: Illinois
city: Evanston
country: United States
facility: Synergy Research Site
state: Illinois
city: Evergreen Park
country: United States
facility: Synergy Research Site
state: Illinois
city: Rockford
country: United States
facility: Synergy Research Site
state: Illinois
city: Evansville
country: United States
facility: Synergy Research Site
state: Indiana
city: Augusta
country: United States
facility: Synergy Research Site
state: Kansas
city: Newton
country: United States
facility: Synergy Research Site
state: Kansas
city: Topeka
country: United States
facility: Synergy Research Site
state: Kansas
city: Wichita
country: United States
facility: Synergy Research Site
state: Kansas
city: Wichita
country: United States
facility: Synergy Research Site
state: Kansas
city: Baton Rouge
country: United States
facility: Synergy Research Site
state: Louisiana
city: Crowley
country: United States
facility: Synergy Research Site
state: Louisiana
city: Mandeville
country: United States
facility: Synergy Research Site
state: Louisiana
city: Metairie
country: United States
facility: Synergy Research Site
state: Louisiana
city: Monroe
country: United States
facility: Synergy Research Site
state: Louisiana
city: New Orleans
country: United States
facility: Synergy Research Site
state: Louisiana
city: Shreveport
country: United States
facility: Synergy Research Site
state: Louisiana
city: Baltimore
country: United States
facility: Synergy Research Site
state: Maryland
city: Hagerstown
country: United States
facility: Synergy Research Site
state: Maryland
city: Boston
country: United States
facility: Synergy Research Site
state: Massachusetts
city: Chesterfield
country: United States
facility: Synergy Research Site
state: Michigan
city: Flint
country: United States
facility: Synergy Research Site
state: Michigan
city: Rochester
country: United States
facility: Synergy Research Site
state: Michigan
city: Wyoming
country: United States
facility: Synergy Research Site
state: Michigan
city: Jackson
country: United States
facility: Synergy Research Site.
state: Mississippi
city: Hazelwood
country: United States
facility: Synergy Research Site
state: Missouri
city: Omaha
country: United States
facility: Synergy Research Site
state: Nebraska
city: Las Vegas
country: United States
facility: Synergy Research Site
state: Nevada
city: Marlton
country: United States
facility: Synergy Research Site
state: New Jersey
city: Albuquerque
country: United States
facility: Synergy Research Site
state: New Mexico
city: Brooklyn
country: United States
facility: Synergy Research Site
state: New York
city: Great Neck
country: United States
facility: Synergy Research Site
state: New York
city: New Windsor
country: United States
facility: Synergy Research Site
state: New York
city: New York
country: United States
facility: Synergy Research Site
state: New York
city: North Massapequa
country: United States
facility: Synergy Research Site
state: New York
city: Asheboro
country: United States
facility: Synergy Research Site
state: North Carolina
city: Cary
country: United States
facility: Synergy Research Site
state: North Carolina
city: Charlotte
country: United States
facility: Synergy Research Site
state: North Carolina
city: Charlotte
country: United States
facility: Synergy Research Site
state: North Carolina
city: Concord
country: United States
facility: Synergy Research Site
state: North Carolina
city: Davidson
country: United States
facility: Synergy Research Site
state: North Carolina
city: Greensboro
country: United States
facility: Synergy Research Site
state: North Carolina
city: Kinston
country: United States
facility: Synergy Research Site
state: North Carolina
city: Lenoir
country: United States
facility: Synergy Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Synergy Research Site
state: North Carolina
city: Wilmington
country: United States
facility: Synergy Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Synergy Research Site
state: North Carolina
city: Fargo
country: United States
facility: Synergy Research Site
state: North Dakota
city: Beavercreek
country: United States
facility: Synergy Research Site
state: Ohio
city: Cincinnati
country: United States
facility: Synergy Research Site
state: Ohio
city: Cleveland
country: United States
facility: Synergy Research Site
state: Ohio
city: Cleveland
country: United States
facility: Synergy Research Site
state: Ohio
city: Englewood
country: United States
facility: Synergy Research Site
state: Ohio
city: Sylvania
country: United States
facility: Synergy Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Synergy Research Site
state: Oklahoma
city: Tulsa
country: United States
facility: Synergy Research Site
state: Oklahoma
city: Portland
country: United States
facility: Synergy Research Site
state: Oregon
city: Levittown
country: United States
facility: Synergy Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Synergy Research Site
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Synergy Research Site
state: Pennsylvania
city: Smithfield
country: United States
facility: Synergy Research Site
state: Pennsylvania
city: Uniontown
country: United States
facility: Synergy Research Site
state: Pennsylvania
city: Columbia
country: United States
facility: Synergy Research Site
state: South Carolina
city: Gaffney
country: United States
facility: Synergy Research Site
state: South Carolina
city: Greer
country: United States
facility: Synergy Research Site.
state: South Carolina
city: North Charleston
country: United States
facility: Synergy Research Site
state: South Carolina
city: Rapid City
country: United States
facility: Synergy Research Site
state: South Dakota
city: Athens
country: United States
facility: Synergy Research Site
state: Tennessee
city: Chattanooga
country: United States
facility: Synergy Research Site
state: Tennessee
city: Memphis
country: United States
facility: Synergy Research Site
state: Tennessee
city: Nashville
country: United States
facility: Synergy Research Site.
state: Tennessee
city: Arlington
country: United States
facility: Synergy Research Site
state: Texas
city: Austin
country: United States
facility: Synergy Research Site
state: Texas
city: Austin
country: United States
facility: Synergy Research Site
state: Texas
city: Carrollton
country: United States
facility: Synergy Research Site
state: Texas
city: Dallas
country: United States
facility: Synergy Research Site
state: Texas
city: Houston
country: United States
facility: Synergy Research Site
state: Texas
city: Houston
country: United States
facility: Synergy Research Site
state: Texas
city: Plano
country: United States
facility: Synergy Research Site
state: Texas
city: San Antonio
country: United States
facility: Synergy Research Site
state: Texas
city: Webster
country: United States
facility: Synergy Research Site
state: Texas
city: Bountiful
country: United States
facility: Synergy Research Site
state: Utah
city: Ogden
country: United States
facility: Synergy Research Site
state: Utah
city: Saint George
country: United States
facility: Synergy Research Site
state: Utah
city: Sandy
country: United States
facility: Synergy Research Site
state: Utah
city: Alexandria
country: United States
facility: Synergy Research Site
state: Virginia
city: Charlottesville
country: United States
facility: Synergy Research Site
state: Virginia
city: Lynchburg
country: United States
facility: Synergy Research Site
state: Virginia
city: Newport News
country: United States
facility: Synergy Research Site
state: Virginia
city: Bellevue
country: United States
facility: Synergy Research Site
state: Washington
city: Spokane
country: United States
facility: Synergy Research Site
state: Washington
city: Charleston
country: United States
facility: Synergy Research Site
state: West Virginia
city: Morgantown
country: United States
facility: Synergy Research Site
state: West Virginia
city: Milwaukee
country: United States
facility: Synergy Research Site
state: Wisconsin
city: Wauwatosa
country: United States
facility: Synergy Research Site
state: Wisconsin
Study officials:
affiliation: Synergy Pharmaceuticals Inc.
name: Paul F.C. Eng, PhD
role: STUDY_DIRECTOR
References:
citation: Menees SB, Franklin H, Chey WD. Evaluation of Plecanatide for the Treatment of Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation in Patients 65 Years or Older. Clin Ther. 2020 Jul;42(7):1406-1414.e4. doi: 10.1016/j.clinthera.2020.05.012. Epub 2020 Jul 10.