Clinical trial NCT02706483: Long Term Safety Study of Plecanatide
Official title: An Open Label, Long Term Safety and Tolerability Study of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Irritable Bowel Syndrome
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2016-03-11
Enrollment: 2272
Sex: ALL
Minimum age (years): 18
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: Multi-center, open-label, long-term safety study

Detailed description: This is a phase 3, multicenter, open-label, long-term safety and tolerability study of 6 mg daily dose of plecanatide administered orally. Patients who are Study Completers or Eligible Screen Failures whose eligibility is confirmed at the end of their participation in the double-blind plecanatide studies SP304203-04 or SP304203-05 will be enrolled.

Beginning on Day 1, patients will take one (1) plecanatide 6.0 mg tablet in the clinic and thereafter every morning with approximately 240 mL (8 ounces) of liquid, with or without meals.

Safety and tolerability assessments and patients' self-assessment of disease severity will be performed according to the Schedule of Assessments.

Patients who discontinue early from the study will undergo an Early Withdrawal (EW) visit within 5 days after stopping study drug.

Eligibility criteria: Inclusion Criteria:

Patients with documented diagnosis of IBS-C who:

* Completed plecanatide study SP304203-04 or SP304203-05, were compliant with the previous study's requirements, and did not experience any Serious Adverse Event (SAE) deemed related to study drug during the course of the previous study, OR
* Failed screening in study SP304203-04 or SP304203-05 due to diary noncompliance (an exclusion in the core study) or due to an administrative reason and is allowed to enter this study by notification from Sponsor or delegate.

Key Exclusion Criteria:

* Patient is unwilling or unable to: participate in the study for the required duration, understand and sign the informed consent form (ICF) and undergo all protocol related tests and procedures throughout the study.
* Female patient of childbearing potential with a positive urine pregnancy test on Day 1.
* Male and female patients of childbearing potential who do not agree to continue to use the method of birth control used in the core double-blind plecanatide study for the duration of this clinical trial.
* Patient has experienced a significant negative change in health status during the course of participation in the core double-blind plecanatide study or after completion of the study.
* In the opinion of the Investigator or Medical Monitor, it is not in the patient's best interest to participate in the study. The reason(s) for the patient's exclusion must be specified.

Primary outcomes:
measure: Number of Participants With Treatment Related Adverse Events.
timeFrame: up to 53 weeks
Secondary outcomes:
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: 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: Chandler
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: Glendale
country: United States
facility: Synergy Research Site
state: Arkansas
city: Little Rock
country: United States
facility: Synergy Research Site
state: Arkansas
city: Artesia
country: United States
facility: Synergy Research Site
state: California
city: Canoga Park
country: United States
facility: Synergy Research Site
state: California
city: Carmichael
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: Costa Mesa
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: Fountain Valley
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: 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: 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: North Hollywood
country: United States
facility: Synergy Research Site
state: California
city: Northridge
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 Bernardino
country: United States
facility: Synergy Research Site
state: California
city: San Diego
country: United States
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state: California
city: San Marino
country: United States
facility: Synergy Research Site
state: California
city: Sherman Oaks
country: United States
facility: Synergy Research Site
state: California
city: Thousand 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: Lafayette
country: United States
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state: Colorado
city: Bristol
country: United States
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state: Connecticut
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: Boynton Beach
country: United States
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state: Florida
city: Bradenton
country: United States
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state: Florida
city: Brandon
country: United States
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state: Florida
city: Brooksville
country: United States
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state: Florida
city: Clearwater
country: United States
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state: Florida
city: Cutler Bay
country: United States
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state: Florida
city: DeLand
country: United States
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state: Florida
city: Fort Lauderdale
country: United States
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state: Florida
city: Hialeah
country: United States
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state: Florida
city: Homestead
country: United States
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state: Florida
city: Inverness
country: United States
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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: 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: 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: Ormond Beach
country: United States
facility: Synergy Research Site
state: Florida
city: Oviedo
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: Saint Petersburg
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: Atlanta
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
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state: Georgia
city: Blackfoot
country: United States
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state: Idaho
city: Boise
country: United States
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state: Idaho
city: Meridian
country: United States
facility: Synergy Research Site
state: Idaho
city: Blue Island
country: United States
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state: Illinois
city: Chicago
country: United States
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state: Illinois
city: Evanston
country: United States
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state: Illinois
city: Evergreen Park
country: United States
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state: Illinois
city: Hoffman Estates
country: United States
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state: Illinois
city: Morton
country: United States
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state: Illinois
city: Oak Lawn
country: United States
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state: Illinois
city: Schaumburg
country: United States
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state: Illinois
city: Brownsburg
country: United States
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state: Indiana
city: Indianapolis
country: United States
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state: Indiana
city: Topeka
country: United States
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state: Kansas
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: 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
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state: Louisiana
city: Marrero
country: United States
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state: Louisiana
city: Metairie
country: United States
facility: Synergy Research Site
state: Louisiana
city: New Orleans
country: United States
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state: Louisiana
city: Shreveport
country: United States
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state: Louisiana
city: Annapolis
country: United States
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state: Maryland
city: Baltimore
country: United States
facility: Synergy Research Site
state: Maryland
city: Hagerstown
country: United States
facility: Synergy Research Site
state: Maryland
city: Oxon Hill
country: United States
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state: Maryland
city: Marlborough
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: Wyoming
country: United States
facility: Synergy Research Site
state: Michigan
city: Jackson
country: United States
facility: Synergy Research Site
state: Mississippi
city: Port Gibson
country: United States
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state: Mississippi
city: Chesterfield
country: United States
facility: Synergy Research Site
state: Missouri
city: Hazelwood
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: 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: Hopewell Junction
country: United States
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state: New York
city: Kew Gardens
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
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state: New York
city: North Massapequa
country: United States
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state: New York
city: Poughkeepsie
country: United States
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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: Davidson
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: Kinston
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: 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: Columbus
country: United States
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state: Ohio
city: Dayton
country: United States
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state: Ohio
city: Englewood
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: Oklahoma City
country: United States
facility: Synergy Research Site
state: Oklahoma
city: Portland
country: United States
facility: Synergy Research Site
state: Oregon
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: Smithfield
country: United States
facility: Synergy Research Site
state: Pennsylvania
city: Anderson
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: 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: 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: Memphis
country: United States
facility: Synergy Research Site
state: Tennessee
city: Nashville
country: United States
facility: Synergy Research Site
state: Tennessee
city: Austin
country: United States
facility: Synergy Research Site
state: Texas
city: Beaumont
country: United States
facility: Synergy Research Site
state: Texas
city: Carrollton
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: 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: Port Arthur
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: Ogden
country: United States
facility: Synergy Research Site
state: Utah
city: Orem
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: Charlottesville
country: United States
facility: Synergy Research Site
state: Virginia
city: Chesapeake
country: United States
facility: Synergy Research Site
state: Virginia
city: Fairfax
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: Norfolk
country: United States
facility: Synergy Research Site
state: Virginia
city: Richmond
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: Kingwood
country: United States
facility: Synergy Research Site
state: West Virginia
city: Morgantown
country: United States
facility: Synergy Research Site
state: West Virginia
city: La Crosse
country: United States
facility: Synergy Research Site
state: Wisconsin
city: Milwaukee
country: United States
facility: Synergy Research Site
state: Wisconsin
Study officials:
affiliation: Bausch Health
name: Angela Bulawski
role: STUDY_DIRECTOR
References:
citation: Barish CF, Crozier RA, Griffin PH. Long-term treatment with plecanatide was safe and tolerable in patients with irritable bowel syndrome with constipation. Curr Med Res Opin. 2019 Jan;35(1):81-85. doi: 10.1080/03007995.2018.1527303. Epub 2018 Oct 9.