Clinical trial NCT02493452: Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C)
Official title: Second Phase 3 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: 2015-07-09
Enrollment: 1135
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 ≥ 40 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 CSBMs (CSBMs/Week)Complete Spontaneous Bowel Movement
timeFrame: Baseline and 12-Week
measure: Number of Patients With a SBM Within 24 Hours After First Dose of Study Medication
timeFrame: Up to 24 hours after the first dose of study drug
measure: Change From Baseline in Abdominal Pain
timeFrame: Baseline and 12-Week
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Synergy Research Site
state: Alabama
city: Birmingham
country: United States
facility: Synergy Research Site
state: Alabama
city: Guntersville
country: United States
facility: Synergy Research Site
state: Alabama
city: Huntsville
country: United States
facility: Synergy Research Site
state: Alabama
city: Saraland
country: United States
facility: Synergy Research Site
state: Alabama
city: Glendale
country: United States
facility: Synergy Research Site
state: Arizona
city: Phoenix
country: United States
facility: Synergy Research Site
state: Arizona
city: Surprise
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: Canoga Park
country: United States
facility: Synergy Research Site
state: California
city: Carmichael
country: United States
facility: Synergy Research Site
state: California
city: Chino
country: United States
facility: Synergy Research Site
state: California
city: Chula Vista
country: United States
facility: Synergy Research Site
state: California
city: El Cajon
country: United States
facility: Synergy Research Site
state: California
city: Encino
country: United States
facility: Synergy Research Site
state: California
city: Foothill Ranch
country: United States
facility: Synergy Research Site
state: California
city: Garden Grove
country: United States
facility: Synergy Research Site
state: California
city: Huntington Beach
country: United States
facility: Synergy Research Site
state: California
city: Irvine
country: United States
facility: Synergy Research Site
state: California
city: Lomita
country: United States
facility: Synergy Research Site
state: California
city: Long Beach
country: United States
facility: Synergy Research Site
state: California
city: Los Angeles
country: United States
facility: Synergy Research Site
state: California
city: Mission Hills
country: United States
facility: Synergy Research Site
state: California
city: Montclair
country: United States
facility: Synergy Research Site
state: California
city: Northridge
country: United States
facility: Synergy Research Site
state: California
city: Norwalk
country: United States
facility: Synergy Research Site
state: California
city: Oceanside
country: United States
facility: Synergy Research Site
state: California
city: Orangevale
country: United States
facility: Synergy Research Site
state: California
city: Orange
country: United States
facility: Synergy Research Site
state: California
city: Placentia
country: United States
facility: Synergy Research Site
state: California
city: Riverside
country: United States
facility: Synergy Research Site
state: California
city: San Diego
country: United States
facility: Synergy Research Site
state: California
city: San Marino
country: United States
facility: Synergy Research Site
state: California
city: Santa Ana
country: United States
facility: Synergy Research Site
state: California
city: Sherman Oaks
country: United States
facility: Synergy Research Site
state: California
city: Colorado Springs
country: United States
facility: Synergy Research Site
state: Colorado
city: Denver
country: United States
facility: Synergy Research Site
state: Colorado
city: Hamden
country: United States
facility: Synergy Research Site
state: Connecticut
city: Atlantis
country: United States
facility: Synergy Research Site
state: Florida
city: Boca Raton
country: United States
facility: Synergy Research Site
state: Florida
city: Bradenton
country: United States
facility: Synergy Research Site
state: Florida
city: Brandon
country: United States
facility: Synergy Research Site
state: Florida
city: Brooksville
country: United States
facility: Synergy Research Site
state: Florida
city: Clearwater
country: United States
facility: Synergy Research Site
state: Florida
city: Cutler Bay
country: United States
facility: Synergy Research Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Synergy Research Site
state: Florida
city: Fort Lauderdale
country: United States
facility: Synergy Research Site
state: Florida
city: Hialeah
country: United States
facility: Synergy Research Site
state: Florida
city: Hialeah
country: United States
facility: Synergy Research Site
state: Florida
city: Hialeah
country: United States
facility: Synergy Research Site
state: Florida
city: Jacksonville
country: United States
facility: Synergy Research Site.
state: Florida
city: Lauderdale Lakes
country: United States
facility: Synergy Research Site
state: Florida
city: Maitland
country: United States
facility: Synergy Research Site
state: Florida
city: Miami Lakes
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: Miami
country: United States
facility: Synergy Research Site
state: Florida
city: Miami
country: United States
facility: Synergy Research Site
state: Florida
city: Miami
country: United States
facility: Synergy Research Site
state: Florida
city: Miami
country: United States
facility: Synergy Research Site
state: Florida
city: Miami
country: United States
facility: Synergy Research Site
state: Florida
city: Miami
country: United States
facility: Synergy Research Site
state: Florida
city: Miami
country: United States
facility: Synergy Research Site
state: Florida
city: Miami
country: United States
facility: Synergy Research Site
state: Florida
city: Miami
country: United States
facility: Synergy Research Site
state: Florida
city: Miami
country: United States
facility: Synergy Research Site
state: Florida
city: Miami
country: United States
facility: Synergy Research Site
state: Florida
city: Naples
country: United States
facility: Synergy Research Site
state: Florida
city: North Miami Beach
country: United States
facility: Synergy Research Site
state: Florida
city: Orange Park
country: United States
facility: Synergy Research Site
state: Florida
city: Orlando
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: Pembroke Pines
country: United States
facility: Synergy Research Site
state: Florida
city: Pinellas Park
country: United States
facility: Synergy Research Site
state: Florida
city: Port Orange
country: United States
facility: Synergy Research Site
state: Florida
city: Tamarac
country: United States
facility: Synergy Research Site
state: Florida
city: Tampa
country: United States
facility: Synergy Research Site
state: Florida
city: Tampa
country: United States
facility: Synergy Research Site
state: Florida
city: Williston
country: United States
facility: Synergy Research Site
state: Florida
city: Atlanta
country: United States
facility: Synergy Research Site
state: Georgia
city: Atlanta
country: United States
facility: Synergy Research Site
state: Georgia
city: Decatur
country: United States
facility: Synergy Research Site
state: Georgia
city: Lilburn
country: United States
facility: Synergy Research Site
state: Georgia
city: Marietta
country: United States
facility: Synergy Research Site
state: Georgia
city: Snellville
country: United States
facility: Synergy Research Site
state: Georgia
city: Blackfoot
country: United States
facility: Synergy Research Site
state: Idaho
city: Boise
country: United States
facility: Synergy Research Site
state: Idaho
city: Meridian
country: United States
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state: Idaho
city: Blue Island
country: United States
facility: Synergy Research Site
state: Illinois
city: Chicago
country: United States
facility: Synergy Research Site
state: Illinois
city: Evanston
country: United States
facility: Synergy Research Site
state: Illinois
city: Hoffman Estates
country: United States
facility: Synergy Research Site
state: Illinois
city: Morton
country: United States
facility: Synergy Research Site
state: Illinois
city: Oak Lawn
country: United States
facility: Synergy Research Site
state: Illinois
city: Schaumburg
country: United States
facility: Synergy Research Site
state: Illinois
city: Brownsburg
country: United States
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state: Indiana
city: Indianapolis
country: United States
facility: Synergy Research Site
state: Indiana
city: Wichita
country: United States
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state: Kansas
city: Madisonville
country: United States
facility: Synergy Research Site
state: Kentucky
city: Owensboro
country: United States
facility: Synergy Research Site
state: Kentucky
city: Marrero
country: United States
facility: Synergy Research Site
state: Louisiana
city: Annapolis
country: United States
facility: Synergy Research Site
state: Maryland
city: Catonsville
country: United States
facility: Synergy Research Site
state: Maryland
city: Oxon Hill
country: United States
facility: Synergy Research Site
state: Maryland
city: Towson
country: United States
facility: Synergy Research Site
state: Maryland
city: Marlborough
country: United States
facility: Synergy Research Site
state: Massachusetts
city: Quincy
country: United States
facility: Synergy Research Site
state: Massachusetts
city: Kalamazoo
country: United States
facility: Synergy Research Site
state: Michigan
city: Port Gibson
country: United States
facility: Synergy Research Site
state: Mississippi
city: Chesterfield
country: United States
facility: Synergy Research Site
state: Missouri
city: Saint Louis
country: United States
facility: Synergy Research Site
state: Missouri
city: Saint Louis
country: United States
facility: Synergy Research Site
state: Missouri
city: Missoula
country: United States
facility: Synergy Research Site
state: Montana
city: Omaha
country: United States
facility: Synergy Research Site
state: Nebraska
city: Las Vegas
country: United States
facility: Synergy Research Site
state: Nevada
city: Blackwood
country: United States
facility: Synergy Research Site
state: New Jersey
city: Egg Harbor Township
country: United States
facility: Synergy Research Site
state: New Jersey
city: Vineland
country: United States
facility: Synergy Research Site
state: New Jersey
city: Albuquerque
country: United States
facility: Synergy Research Site
state: New Mexico
city: Hopewell Junction
country: United States
facility: Synergy Research Site
state: New York
city: Kew Gardens
country: United States
facility: Synergy Research Site
state: New York
city: New York
country: United States
facility: Synergy Research Site
state: New York
city: Poughkeepsie
country: United States
facility: Synergy Research Site
state: New York
city: Chapel Hill
country: United States
facility: Synergy Research Site
state: North Carolina
city: Fayetteville
country: United States
facility: Synergy Research Site
state: North Carolina
city: High Point
country: United States
facility: Synergy Research Site
state: North Carolina
city: Jacksonville
country: United States
facility: Synergy Research Site
state: North Carolina
city: Raleigh
country: United States
facility: Synergy Research Site
state: North Carolina
city: Salisbury
country: United States
facility: Synergy Research Site
state: North Carolina
city: Winston-Salem
country: United States
facility: Synergy Research Site
state: North Carolina
city: Cincinnati
country: United States
facility: Synergy Research Site
state: Ohio
city: Cincinnati
country: United States
facility: Synergy Research Site
state: Ohio
city: Cincinnati
country: United States
facility: Synergy Research Site
state: Ohio
city: Columbus
country: United States
facility: Synergy Research Site
state: Ohio
city: Dayton
country: United States
facility: Synergy Research Site
state: Ohio
city: Dayton
country: United States
facility: Synergy Research Site
state: Ohio
city: Franklin
country: United States
facility: Synergy Research Site
state: Ohio
city: Kettering
country: United States
facility: Synergy Research Site
state: Ohio
city: Mentor
country: United States
facility: Synergy Research Site
state: Ohio
city: Middleburg Heights
country: United States
facility: Synergy Research Site
state: Ohio
city: Wadsworth
country: United States
facility: Synergy Research Site
state: Ohio
city: Oklahoma City
country: United States
facility: Synergy Research Site
state: Oklahoma
city: Doylestown
country: United States
facility: Synergy Research Site
state: Pennsylvania
city: Lansdale
country: United States
facility: Synergy Research Site
state: Pennsylvania
city: Levittown
country: United States
facility: Synergy Research Site
state: Pennsylvania
city: Philadelphia
country: United States
facility: Synergy Research Site
state: Pennsylvania
city: Anderson
country: United States
facility: Synergy Research Site
state: South Carolina
city: Greer
country: United States
facility: Synergy Research Site
state: South Carolina
city: Mount Pleasant
country: United States
facility: Synergy Research Site
state: South Carolina
city: Fayetteville
country: United States
facility: Synergy Research Site
state: Tennessee
city: Franklin
country: United States
facility: Synergy Research Site
state: Tennessee
city: Hermitage
country: United States
facility: Synergy Research Site
state: Tennessee
city: Jackson
country: United States
facility: Synergy Research Site
state: Tennessee
city: Kingsport
country: United States
facility: Synergy Research Site
state: Tennessee
city: Knoxville
country: United States
facility: Synergy Research Site
state: Tennessee
city: Austin
country: United States
facility: Synergy Research Site
state: Texas
city: Austin
country: United States
facility: Synergy Research Site
state: Texas
city: Baytown
country: United States
facility: Synergy Research Site
state: Texas
city: Beaumont
country: United States
facility: Synergy Research Site
state: Texas
city: Channelview
country: United States
facility: Synergy Research Site
state: Texas
city: Dallas
country: United States
facility: Synergy Research Site
state: Texas
city: Dallas
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: Humble
country: United States
facility: Synergy Research Site
state: Texas
city: Lampasas
country: United States
facility: Synergy Research Site
state: Texas
city: McKinney
country: United States
facility: Synergy Research Site
state: Texas
city: Missouri City
country: United States
facility: Synergy Research Site
state: Texas
city: Plano
country: United States
facility: Synergy Research Site
state: Texas
city: Plano
country: United States
facility: Synergy Research Site
state: Texas
city: Port Arthur
country: United States
facility: Synergy Research Site
state: Texas
city: San Antonio
country: United States
facility: Synergy Research Site
state: Texas
city: San Antonio
country: United States
facility: Synergy Research Site
state: Texas
city: San Antonio
country: United States
facility: Synergy Research Site
state: Texas
city: Sugar Land
country: United States
facility: Synergy Research Site
state: Texas
city: Orem
country: United States
facility: Synergy Research Site
state: Utah
city: West Valley City
country: United States
facility: Synergy Research Site
state: Utah
city: Chesapeake
country: United States
facility: Synergy Research Site
state: Virginia
city: Fairfax
country: United States
facility: Synergy Research Site
state: Virginia
city: Norfolk
country: United States
facility: Synergy Research Site
state: Virginia
city: Richmond
country: United States
facility: Synergy Research Site
state: Virginia
city: Richmond
country: United States
facility: Synergy Research Site
state: Virginia
city: Spokane
country: United States
facility: Synergy Research Site
state: Washington
city: Vancouver
country: United States
facility: Synergy Research Site
state: Washington
city: Kingwood
country: United States
facility: Synergy Research Site
state: West Virginia
city: La Crosse
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.