Clinical trial NCT01919697: Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)
Official title: An Open-Label Extension (OLE), Long-term Safety and Tolerability Study of Plecanatide in Patients With Chronic Idiopathic Constipation (CIC)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Idiopathic Constipation
Keywords: Plecantaide
Chronic Idiopathic Constipation
Chronic
Idiopathic
Constipation
Synergy
CIC
CIC study
CIC OLE
CIC OLE study
OLE
OLE CIC
OLE CIC3
Open label
Open label study
Long term
Long term study
Extension
Extension study
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
Collaborators: name: Syneos Health
First posted: 2013-08-09
Enrollment: 2370
Sex: ALL
Minimum age (years): 18
Maximum age (years): 81
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in patients with Chronic Idiopathic Constipation (CIC).

Detailed description: This is an open-label extension study of plecanatide in the treatment of patients with CIC who previously completed Synergy Protocols SP304-20210 and SP304203-00 (The CIC3 Study).

The planned duration of each patient's study participation is up to 411 days, including up to 33 days of screening, 8 study visits over 52 weeks of treatment and a follow-up visit 2 weeks after the last dose of study drug.

Eligibility criteria: Inclusion Criteria:

* Patient completed a previous double-blind plecanatide study and was compliant with the study requirements.
* Patient is in good health without unstable acute illness or exacerbation of an unstable chronic illness or chronic disease that may affect study assessments, particularly if there has been a significant change to health status since the previous plecanatide study.

Exclusion Criteria:

* Patient has had major surgery including laparoscopic procedures requiring general anesthesia within 60 days of Day 1.
* Patient has a medical history of hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection.
* Patient has taken a protocol-prohibited drug without the appropriate washout period.

Primary outcomes:
measure: Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE)
timeFrame: From first dose up to 72 weeks
measure: Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide
timeFrame: From first dose up to 72 weeks
measure: Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg)
timeFrame: From first dose up to 72 weeks
measure: Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute)
timeFrame: From first dose up to 72 weeks
measure: Summary of Vital Signs at >Day 364 - Body Temperature (°C)
timeFrame: From first dose up to 72 weeks
measure: Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute)
timeFrame: From first dose up to 72 weeks
measure: Summary of ECG Results Shift From Baseline at > Day 364
timeFrame: From first dose up to 72 weeks
measure: Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline
timeFrame: From first dose up to 72 weeks
Secondary outcomes:
measure: Summary of Patient Patient Global Assessment (PGA) for Constipation Severity at > Day 364
timeFrame: Form first dose up to 72 weeks
measure: Summary of Patient Global Assessment (PGA) for Constipation - Change From Baseline to > Day 364
timeFrame: From first dose up to 72 weeks
measure: Summary of Patient Global Assessment (PGA) for Treatment Satisfaction at > Day 364
timeFrame: From first dose up to 72 weeks
measure: Summary of Patient Global Assessment (PGA) for Treatment Continuation at End of Treatment
timeFrame: From first dose up to 72 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: Synergy Research Site
state: Alabama
city: Dothan
country: United States
facility: Synergy Research Site
state: Alabama
city: Gulf Shores
country: United States
facility: Synergy Research Site
state: Alabama
city: Huntsville
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: Tempe
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: Tucson
country: United States
facility: Synergy Research Site
state: Arizona
city: Little Rock
country: United States
facility: Synergy Research Site
state: Arkansas
city: North Little Rock
country: United States
facility: Synergy Research Site
state: Arkansas
city: Anaheim
country: United States
facility: Synergy Research Site
state: California
city: Anaheim
country: United States
facility: Synergy Research Site
state: California
city: Artesia
country: United States
facility: Synergy Research Site
state: California
city: Carlsbad
country: United States
facility: Synergy Research Site
state: California
city: Cerritos
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: Encinitas
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: Hawaiian Gardens
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: Long Beach
country: United States
facility: Synergy Research Site
state: California
city: Los Angeles
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: North Hollywood
country: United States
facility: Synergy Research Site
state: California
city: Orange
country: United States
facility: Synergy Research Site
state: California
city: Pasadena
country: United States
facility: Synergy Research Site
state: California
city: Sacramento
country: United States
facility: Synergy Research Site
state: California
city: San Diego
country: United States
facility: Synergy Research Site
state: California
city: San Diego
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: Colorado Springs
country: United States
facility: Synergy Research Site
state: Colorado
city: Colorado Springs
country: United States
facility: Synergy Research Site
state: Colorado
city: Colorado Springs
country: United States
facility: Synergy Research Site
state: Colorado
city: Denver
country: United States
facility: Synergy Research Site
state: Colorado
city: Denver
country: United States
facility: Synergy Research Site
state: Colorado
city: Denver
country: United States
facility: Synergy Research Site
state: Colorado
city: Littleton
country: United States
facility: Synergy Research Site
state: Colorado
city: Bristol
country: United States
facility: Synergy Research Site
state: Connecticut
city: Waterbury
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: Clearwater
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: DeLand
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: Homestead
country: United States
facility: Synergy Research Site
state: Florida
city: Jupiter
country: United States
facility: Synergy Research Site
state: Florida
city: Lakeland
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: 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: Orlando
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: Pembroke Pines
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: Tampa
country: United States
facility: Synergy Research Site
state: Florida
city: West Palm Beach
country: United States
facility: Synergy Research Site
state: Florida
city: Athens
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: Decatur
country: United States
facility: Synergy Research Site
state: Georgia
city: Oakwood
country: United States
facility: Synergy Research Site
state: Georgia
city: Sandy Springs
country: United States
facility: Synergy Research Site
state: Georgia
city: Savannah
country: United States
facility: Synergy Research Site
state: Georgia
city: Smyrna
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: Chicago
country: United States
facility: Synergy Research Site
state: Illinois
city: Brownsburg
country: United States
facility: Synergy Research Site
state: Indiana
city: Clive
country: United States
facility: Synergy Research Site
state: Iowa
city: Augusta
country: United States
facility: Synergy Research Site
state: Kansas
city: Newton
country: United States
facility: Synergy Research Site
state: Kansas
city: Shawnee Mission
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: Lexington
country: United States
facility: Synergy Research Site
state: Kentucky
city: Owensboro
country: United States
facility: Synergy Research Site
state: Kentucky
city: Bastrop
country: United States
facility: Synergy Research Site
state: Louisiana
city: Marrero
country: United States
facility: Synergy Research Site
state: Louisiana
city: Metairie
country: United States
facility: Synergy Research Site
state: Louisiana
city: New Orleans
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: Chevy Chase
country: United States
facility: Synergy Research Site
state: Maryland
city: Boston
country: United States
facility: Synergy Research Site
state: Massachusetts
city: New Bedford
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: Saginaw
country: United States
facility: Synergy Research Site
state: Michigan
city: Southfield
country: United States
facility: Synergy Research Site
state: Michigan
city: Biloxi
country: United States
facility: Synergy Research Site
state: Mississippi
city: Jackson
country: United States
facility: Synergy Research Site
state: Mississippi
city: Saint Louis
country: United States
facility: Synergy Research Site
state: Missouri
city: Grand Island
country: United States
facility: Synergy Research Site
state: Nebraska
city: Omaha
country: United States
facility: Synergy Research Site
state: Nebraska
city: Henderson
country: United States
facility: Synergy Research Site
state: Nevada
city: Las Vegas
country: United States
facility: Synergy Research Site
state: Nevada
city: Las Vegas
country: United States
facility: Synergy Research Site
state: Nevada
city: Las Vegas
country: United States
facility: Synergy Research Site
state: Nevada
city: Reno
country: United States
facility: Synergy Research Site
state: Nevada
city: Elizabeth
country: United States
facility: Synergy Research Site
state: New Jersey
city: Lodi
country: United States
facility: Synergy Research Site
state: New Jersey
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: 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 York
country: United States
facility: Synergy Research Site
state: New York
city: Poughkeepsie
country: United States
facility: Synergy Research Site
state: New York
city: Cary
country: United States
facility: Synergy Research Site
state: North Carolina
city: Chapel Hill
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: Greensboro
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: 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: Centerville
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: Cleveland
country: United States
facility: Synergy Research Site
state: Ohio
city: Huber Heights
country: United States
facility: Synergy Research Site
state: Ohio
city: Maumee
country: United States
facility: Synergy Research Site
state: Ohio
city: Mentor
country: United States
facility: Synergy Research Site
state: Ohio
city: Oakwood
country: United States
facility: Synergy Research Site
state: Ohio
city: Stow
country: United States
facility: Synergy Research Site
state: Ohio
city: Norman
country: United States
facility: Synergy Research Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Synergy Research Site
state: Oklahoma
city: Oklahoma City
country: United States
facility: Synergy Research Site
state: Oklahoma
city: Levittown
country: United States
facility: Synergy Research Site
state: Pennsylvania
city: Limerick
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: Yardley
country: United States
facility: Synergy Research Site
state: Pennsylvania
city: Anderson
country: United States
facility: Synergy Research Site
state: South Carolina
city: Charleston
country: United States
facility: Synergy Research Site
state: South Carolina
city: Columbia
country: United States
facility: Synergy Research Site
state: South Carolina
city: Chattanooga
country: United States
facility: Synergy Research Site
state: Tennessee
city: Franklin
country: United States
facility: Synergy Research Site
state: Tennessee
city: Jackson
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: New Tazewell
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: 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: Houston
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: Houston
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: Katy
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: San Antonio
country: United States
facility: Synergy Research Site
state: Texas
city: Sugar Land
country: United States
facility: Synergy Research Site
state: Texas
city: Logan
country: United States
facility: Synergy Research Site
state: Utah
city: Saint George
country: United States
facility: Synergy Research Site
state: Utah
city: Salt Lake City
country: United States
facility: Synergy Research Site
state: Utah
city: West Jordan
country: United States
facility: Synergy Research Site
state: Utah
city: Christiansburg
country: United States
facility: Synergy Research Site
state: Virginia
city: Henrico
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: Norfolk
country: United States
facility: Synergy Research Site
state: Virginia
city: Richmond
country: United States
facility: Synergy Research Site
state: Virginia
city: Richland
country: United States
facility: Synergy Research Site
state: Washington
city: Seattle
country: United States
facility: Synergy Research Site
state: Washington
city: Tacoma
country: United States
facility: Synergy Research Site
state: Washington
city: Wauwatosa
country: United States
facility: Synergy Research Site
state: Wisconsin
city: Kelowna
country: Canada
facility: Synergy Research Site
state: British Columbia
city: Bridgewater
country: Canada
facility: Synergy Research Site
state: Nova Scotia
city: Cambridge
country: Canada
facility: Synergy Research Site
state: Ontario
city: Sudbury
country: Canada
facility: Synergy Research Site
state: Ontario
city: Toronto
country: Canada
facility: Synergy Research Site
state: Ontario
city: Toronto
country: Canada
facility: Synergy Research Site
state: Ontario
city: Mirabel
country: Canada
facility: Synergy Research Site
state: Quebec
city: Pointe-Claire
country: Canada
facility: Synergy Research Site
state: Quebec
city: St-Romuald
country: Canada
facility: Synergy Research Site
state: Quebec
Study officials:
affiliation: ClinSearch, LLC
name: Richard A Krause, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Barish CF, Griffin P. Safety and tolerability of plecanatide in patients with chronic idiopathic constipation: long-term evidence from an open-label study. Curr Med Res Opin. 2018 Apr;34(4):751-755. doi: 10.1080/03007995.2018.1430024. Epub 2018 Feb 2.