Clinical trial NCT01982240: 12-Week Study of Plecanatide for CIC (The CIC3 Study)
Official title: A Randomized, 12-Week, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Plecanatide (3.0 and 6.0 mg) in Patients With Chronic Idiopathic Constipation (The CIC3 Study)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Idiopathic Constipation
Keywords: CIC
Constipation
Chronic Constipation
Synergy
Plecanatide
Lead sponsor: Bausch Health Americas, Inc.
Sponsor class: INDUSTRY
First posted: 2013-11-13
Enrollment: 1394
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to confirm that the investigational medication, plecanatide, is safe and effective in treating chronic idiopathic constipation.

Detailed description: This is a randomized, 12-week, double-blind, placebo-controlled, study in approximately 1350 adult male and female patients with CIC comparing 2 doses of plecanatide to placebo. The study will be conducted at approximately 180 clinical study sites in the United States (US) and Canada. The primary objective of the study is to evaluate the efficacy and safety of 3.0 and 6.0 mg of plecanatide administered once daily (QD) for 12 weeks in a population of patients with CIC. The study population will include only patients without other causes of constipation or other chronic conditions that could interfere with study assessments. Patients may not take laxatives (with the exception of the study-provided rescue medication, bisacodyl 5mg tablets), or a number of prohibited drugs that are known to cause constipation or diarrhea, during study participation.

There are 6 scheduled study visits, including the screening and follow-up visits. The planned duration of participation in this study will be 112 days and up to 155 days, with washout and all visit windows considered.

Eligibility criteria: Inclusion Criteria:

* Male or female aged 18-80, inclusive
* Meets modified Rome III criteria for functional chronic idiopathic constipation for at least 3 months with symptom onset for at least 6 months
* Completed a colonoscopy in accordance with AGA colon cancer screening guidelines (5 years), with no clinically significant findings
* Willing to maintain a stable diet during the study

Exclusion Criteria:

* Loose stool (mushy) or watery (Bristol score 6 or 7) stool in the absence of any laxative or prohibited medicine for \> 25% of BMs during the 3 months prior to screening visit OR during the 14 day pre-treatment assessment
* Active peptic ulcer disease, diabetes or hypertension not adequately treated or not stable
* History of cathartic colon, laxative, enema abuse, or ischemic colitis
* Fecal impaction within 3 months of screening
* Patient has had /has any: diseases or conditions associated with constipation (GI or CNS), structural abnormality of the GI tract or gastric bypass surgery, pelvic floor dysfunction, pseudo-obstruction, active infectious gastritis, diverticulitis, anal fissures or any disease or condition that can affect GI motility or defecation or can be associated with abdominal pain
* Unexplained and clinically significant "alarm symptoms" including lower GI bleeding, iron-deficiency anemia, weight loss or systemic signs of infection or colitis
* Major surgery, stroke or MI within 60 days of screening
* Participated in a previous plecanatide clinical trial

Primary outcomes:
measure: Number of Durable Overall CSBM Responders , Mean Replacement Approach
timeFrame: 12-week Treatment Period
Secondary outcomes:
measure: Change From Baseline in CSBMs (CSBMS/Week) Over 12-week Treatment Period, Mean Replacement Approach
timeFrame: 12-Week Treatment Period
measure: Change From Baseline in SBM (SBMs/Week) Over 12-week Treatment Period, Mean Replacement Approach
timeFrame: 12-Week Treatment Period
measure: Change From Baseline in Stool Consistency Score Over the 12-week Treatment Period, Mean Replacement Approach
timeFrame: 12-Week Treatment Period
measure: Change From Baseline in Straining Score Over 12-Week Treatment Period, Mean Replacement Approach
timeFrame: 12-Week Treatment Period
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: Mobile
country: United States
facility: Synergy Research Site
state: Alabama
city: Mesa
country: United States
facility: Synergy Research Site
state: Arizona
city: Phoenix
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: Hot Springs
country: United States
facility: Synergy Research Site
state: Arkansas
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: 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: El Cajon
country: United States
facility: Synergy Research Site
state: California
city: Encinitas
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: Hawaiian Gardens
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: Los Angeles
country: United States
facility: Synergy Research Site
state: California
city: Mission Hills
country: United States
facility: Synergy Research Site
state: California
city: Murrieta
country: United States
facility: Synergy Research Site
state: California
city: North Hollywood
country: United States
facility: Synergy Research Site
state: California
city: Oceanside
country: United States
facility: Synergy Research Site
state: California
city: Oxnard
country: United States
facility: Synergy Research Site
state: California
city: Pasadena
country: United States
facility: Synergy Research Site
state: California
city: Poway
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: 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: 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: Danbury
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
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state: Florida
city: Clearwater
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: Fort Lauderdale
country: United States
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state: Florida
city: Hialeah
country: United States
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state: Florida
city: Jupiter
country: United States
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state: Florida
city: Lakeland
country: United States
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state: Florida
city: Lynn Haven
country: United States
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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: Port Orange
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: Tampa
country: United States
facility: Synergy Research Site
state: Florida
city: Athens
country: United States
facility: Synergy Research Site
state: Georgia
city: Augusta
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: Johns Creek
country: United States
facility: Synergy Research Site
state: Georgia
city: Oakwood
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: Evanston
country: United States
facility: Synergy Research Site
state: Illinois
city: Clive
country: United States
facility: Synergy Research Site
state: Iowa
city: Augusta
country: United States
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state: Kansas
city: Newton
country: United States
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state: Kansas
city: Shawnee Mission
country: United States
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state: Kansas
city: Wichita
country: United States
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state: Kansas
city: Wichita
country: United States
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state: Kansas
city: Lexington
country: United States
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state: Kentucky
city: Lexington
country: United States
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state: Kentucky
city: Bastrop
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
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state: Louisiana
city: New Orleans
country: United States
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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: Brockton
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
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state: Michigan
city: Flint
country: United States
facility: Synergy Research Site
state: Michigan
city: Rochester
country: United States
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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
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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: 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: Reno
country: United States
facility: Synergy Research Site
state: Nevada
city: Lebanon
country: United States
facility: Synergy Research Site
state: New Hampshire
city: Lodi
country: United States
facility: Synergy Research Site
state: New Jersey
city: Ocean City
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: North Massapequa
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: Hilliard
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: Limerick
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: 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: Jackson
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: Austin
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: Killeen
country: United States
facility: Synergy Research Site
state: Texas
city: Plano
country: United States
facility: Synergy Research Site
state: Texas
city: San Angelo
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: 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: 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: Virginia Beach
country: United States
facility: Synergy Research Site
state: Virginia
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: Brampton
country: Canada
facility: Synergy Research Site
state: Ontario
city: Cambridge
country: Canada
facility: Synergy Research Site
state: Ontario
city: London
country: Canada
facility: Synergy Research Site
state: Ontario
city: Oshawa
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: Synergy Pharmaceuticals Inc.
name: Mary Beth Layton
role: STUDY_DIRECTOR
References:
citation: Moshiree B, Schoenfeld P, Franklin H, Rezaie A. The Effect of Acid Suppression Therapy on the Safety and Efficacy of Plecanatide: Analysis of Randomized Phase III Trials. Clin Ther. 2022 Jan;44(1):98-110.e1. doi: 10.1016/j.clinthera.2021.11.009. Epub 2022 Jan 25.
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.
citation: Miner PB Jr, Koltun WD, Wiener GJ, De La Portilla M, Prieto B, Shailubhai K, Layton MB, Barrow L, Magnus L, Griffin PH. A Randomized Phase III Clinical Trial of Plecanatide, a Uroguanylin Analog, in Patients With Chronic Idiopathic Constipation. Am J Gastroenterol. 2017 Apr;112(4):613-621. doi: 10.1038/ajg.2016.611. Epub 2017 Feb 7.