12-Week Study of Plecanatide for CIC (The CIC3 Study)

Chronic Idiopathic Constipation Clinical Trial

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01982240
• Other study ID #: SP304203-00
• Status: Completed
• Phase: Phase 3
• Start date: November 2013
• Est. completion date: June 2015

Study information

• Verified date: December 2019
• Source: Bausch Health Americas, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1394
• Est. completion date: June 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Chronic Idiopathic Constipation
• Constipation

Intervention

Drug:
• Plecanatide
Plecanatide tablets QD for 12 weeks
• Placebo
Matching placebo tablets QD for 12 weeks
• Bisacodyl
Rescue medication

Locations

Country	Name	City	State
Canada	Synergy Research Site	Brampton	Ontario
Canada	Synergy Research Site	Bridgewater	Nova Scotia
Canada	Synergy Research Site	Cambridge	Ontario
Canada	Synergy Research Site	Kelowna	British Columbia
Canada	Synergy Research Site	London	Ontario
Canada	Synergy Research Site	Mirabel	Quebec
Canada	Synergy Research Site	Oshawa	Ontario
Canada	Synergy Research Site	Pointe-Claire	Quebec
Canada	Synergy Research Site	St-Romuald	Quebec
Canada	Synergy Research Site	Sudbury	Ontario
Canada	Synergy Research Site	Toronto	Ontario
Canada	Synergy Research Site	Toronto	Ontario
United States	Synergy Research Site	Albuquerque	New Mexico
United States	Synergy Research Site	Anaheim	California
United States	Synergy Research Site	Anaheim	California
United States	Synergy Research Site	Anderson	South Carolina
United States	Synergy Research Site	Athens	Georgia
United States	Synergy Research Site	Augusta	Georgia
United States	Synergy Research Site	Augusta	Kansas
United States	Synergy Research Site	Austin	Texas
United States	Synergy Research Site	Bastrop	Louisiana
United States	Synergy Research Site	Beavercreek	Ohio
United States	Synergy Research Site	Biloxi	Mississippi
United States	Synergy Research Site	Birmingham	Alabama
United States	Synergy Research Site	Boston	Massachusetts
United States	Synergy Research Site	Boynton Beach	Florida
United States	Synergy Research Site	Bristol	Connecticut
United States	Synergy Research Site	Brockton	Massachusetts
United States	Synergy Research Site	Brooklyn	New York
United States	Synergy Research Site	Carlsbad	California
United States	Synergy Research Site	Cary	North Carolina
United States	Synergy Research Site	Centerville	Ohio
United States	Synergy Research Site	Cerritos	California
United States	Synergy Research Site	Chapel Hill	North Carolina
United States	Synergy Research Site	Charleston	South Carolina
United States	Synergy Research Site	Charlotte	North Carolina
United States	Synergy Research Site	Charlotte	North Carolina
United States	Synergy Research Site	Chattanooga	Tennessee
United States	Synergy Research Site	Chesterfield	Michigan
United States	Synergy Research Site	Chevy Chase	Maryland
United States	Synergy Research Site	Christiansburg	Virginia
United States	Synergy Research Site	Chula Vista	California
United States	Synergy Research Site	Cincinnati	Ohio
United States	Synergy Research Site	Clearwater	Florida
United States	Synergy Research Site	Clive	Iowa
United States	Synergy Research Site	Colorado Springs	Colorado
United States	Synergy Research Site	Colorado Springs	Colorado
United States	Synergy Research Site	Columbia	South Carolina
United States	Synergy Research Site	Dallas	Texas
United States	Synergy Research Site	Dallas	Texas
United States	Synergy Research Site	Danbury	Connecticut
United States	Synergy Research Site	Decatur	Georgia
United States	Synergy Research Site	Decatur	Georgia
United States	Synergy Research Site	DeLand	Florida
United States	Synergy Research Site	Denver	Colorado
United States	Synergy Research Site	Denver	Colorado
United States	Synergy Research Site	Denver	Colorado
United States	Synergy Research Site	Dothan	Alabama
United States	Synergy Research Site	El Cajon	California
United States	Synergy Research Site	Encinitas	California
United States	Synergy Research Site	Encino	California
United States	Synergy Research Site	Evanston	Illinois
United States	Synergy Research Site	Fargo	North Dakota
United States	Synergy Research Site	Flint	Michigan
United States	Synergy Research Site	Fort Lauderdale	Florida
United States	Synergy Research Site	Fort Lauderdale	Florida
United States	Synergy Research Site	Fountain Valley	California
United States	Synergy Research Site	Fresno	California
United States	Synergy Research Site	Great Neck	New York
United States	Synergy Research Site	Greensboro	North Carolina
United States	Synergy Research Site	Gulf Shores	Alabama
United States	Synergy Research Site	Hawaiian Gardens	California
United States	Synergy Research Site	Henderson	Nevada
United States	Synergy Research Site	Henrico	Virginia
United States	Synergy Research Site	Hialeah	Florida
United States	Synergy Research Site	Hilliard	Ohio
United States	Synergy Research Site	Hot Springs	Arkansas
United States	Synergy Research Site	Houston	Texas
United States	Synergy Research Site	Houston	Texas
United States	Synergy Research Site	Houston	Texas
United States	Synergy Research Site	Houston	Texas
United States	Synergy Research Site	Huber Heights	Ohio
United States	Synergy Research Site	Huntsville	Alabama
United States	Synergy Research Site	Jackson	Tennessee
United States	Synergy Research Site	Jackson	Mississippi
United States	Synergy Research Site	Johns Creek	Georgia
United States	Synergy Research Site	Jupiter	Florida
United States	Synergy Research Site	Killeen	Texas
United States	Synergy Research Site	Kinston	North Carolina
United States	Synergy Research Site	Lakeland	Florida
United States	Synergy Research Site	Lancaster	California
United States	Synergy Research Site	Las Vegas	Nevada
United States	Synergy Research Site	Las Vegas	Nevada
United States	Synergy Research Site	Lebanon	New Hampshire
United States	Synergy Research Site	Lexington	Kentucky
United States	Synergy Research Site	Lexington	Kentucky
United States	Synergy Research Site	Limerick	Pennsylvania
United States	Synergy Research Site	Little Rock	Arkansas
United States	Synergy Research Site	Littleton	Colorado
United States	Synergy Research Site	Lodi	New Jersey
United States	Synergy Research Site	Logan	Utah
United States	Synergy Research Site	Long Beach	California
United States	Synergy Research Site	Los Angeles	California
United States	Synergy Research Site	Los Angeles	California
United States	Synergy Research Site	Los Angeles	California
United States	Synergy Research Site	Lynchburg	Virginia
United States	Synergy Research Site	Lynn Haven	Florida
United States	Synergy Research Site	Marrero	Louisiana
United States	Synergy Research Site	Maumee	Ohio
United States	Synergy Research Site	Mentor	Ohio
United States	Synergy Research Site	Mesa	Arizona
United States	Synergy Research Site	Metairie	Louisiana
United States	Synergy Research Site	Miami	Florida
United States	Synergy Research Site	Miami	Florida
United States	Synergy Research Site	Miami	Florida
United States	Synergy Research Site	Miami	Florida
United States	Synergy Research Site	Miami	Florida
United States	Synergy Research Site	Miami	Florida
United States	Synergy Research Site	Mission Hills	California
United States	Synergy Research Site	Mobile	Alabama
United States	Synergy Research Site	Murrieta	California
United States	Synergy Research Site	Nashville	Tennessee
United States	Synergy Research Site	New Bedford	Massachusetts
United States	Synergy Research Site	New Orleans	Louisiana
United States	Synergy Research Site	New Orleans	Louisiana
United States	Synergy Research Site	New Tazewell	Tennessee
United States	Synergy Research Site	Newton	Kansas
United States	Synergy Research Site	Norfolk	Virginia
United States	Synergy Research Site	Norfolk	Virginia
United States	Synergy Research Site	Norman	Oklahoma
United States	Synergy Research Site	North Hollywood	California
United States	Synergy Research Site	North Little Rock	Arkansas
United States	Synergy Research Site	North Massapequa	New York
United States	Synergy Research Site	Oakwood	Ohio
United States	Synergy Research Site	Oakwood	Georgia
United States	Synergy Research Site	Ocean City	New Jersey
United States	Synergy Research Site	Oceanside	California
United States	Synergy Research Site	Oklahoma City	Oklahoma
United States	Synergy Research Site	Omaha	Nebraska
United States	Synergy Research Site	Orlando	Florida
United States	Synergy Research Site	Orlando	Florida
United States	Synergy Research Site	Oxnard	California
United States	Synergy Research Site	Pasadena	California
United States	Synergy Research Site	Philadelphia	Pennsylvania
United States	Synergy Research Site	Phoenix	Arizona
United States	Synergy Research Site	Phoenix	Arizona
United States	Synergy Research Site	Plano	Texas
United States	Synergy Research Site	Port Orange	Florida
United States	Synergy Research Site	Poway	California
United States	Synergy Research Site	Raleigh	North Carolina
United States	Synergy Research Site	Reno	Nevada
United States	Synergy Research Site	Richmond	Virginia
United States	Synergy Research Site	Rochester	Michigan
United States	Synergy Research Site	Sacramento	California
United States	Synergy Research Site	Saginaw	Michigan
United States	Synergy Research Site	Saint George	Utah
United States	Synergy Research Site	Saint Louis	Missouri
United States	Synergy Research Site	Salt Lake City	Utah
United States	Synergy Research Site	San Angelo	Texas
United States	Synergy Research Site	San Antonio	Texas
United States	Synergy Research Site	San Antonio	Texas
United States	Synergy Research Site	San Diego	California
United States	Synergy Research Site	San Diego	California
United States	Synergy Research Site	San Diego	California
United States	Synergy Research Site	San Diego	California
United States	Synergy Research Site	Savannah	Georgia
United States	Synergy Research Site	Seattle	Washington
United States	Synergy Research Site	Shawnee Mission	Kansas
United States	Synergy Research Site	Shreveport	Louisiana
United States	Synergy Research Site	Smithfield	Pennsylvania
United States	Synergy Research Site	Smyrna	Georgia
United States	Synergy Research Site	Southfield	Michigan
United States	Synergy Research Site	Stow	Ohio
United States	Synergy Research Site	Sugar Land	Texas
United States	Synergy Research Site	Tacoma	Washington
United States	Synergy Research Site	Tampa	Florida
United States	Synergy Research Site	Tampa	Florida
United States	Synergy Research Site	Tampa	Florida
United States	Synergy Research Site	Tempe	Arizona
United States	Synergy Research Site	Thousand Oaks	California
United States	Synergy Research Site	Tucson	Arizona
United States	Synergy Research Site	Virginia Beach	Virginia
United States	Synergy Research Site	Waterbury	Connecticut
United States	Synergy Research Site	Wauwatosa	Wisconsin
United States	Synergy Research Site	Wichita	Kansas
United States	Synergy Research Site	Wichita	Kansas
United States	Synergy Research Site	Wilmington	North Carolina
United States	Synergy Research Site	Winston-Salem	North Carolina
United States	Synergy Research Site	Yardley	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Durable Overall CSBM Responders , Mean Replacement Approach	A durable overall CSBM responder was defined as a weekly CSBM responder for at least 9 of the 12 treatment weeks, included at least 3 of the last 4 weeks. A CSBM weekly responder was defined as a patient who has = 3 Complete Spontaneous Bowel Movements (CSBMs) per week and an increase from baseline of =1 CSBM for that week. A CSBM was a bowel movement that occurred in the absence of laxative use within 24 hours and was associated with the feeling of complete evacuation.	12-week Treatment Period
Secondary	Change From Baseline in CSBMs (CSBMS/Week) Over 12-week Treatment Period, Mean Replacement Approach	A Complete Spontaneous Bowel Movement (CSBM) was a Bowel Movement (BM) that occurred in the absence of laxative use within 24 hours of the BM and the patient reported a feeling of complete evacuation. A weekly responder had 3 or more CSBMs and an increase of at least one CSBM from baseline in the same week.	12-Week Treatment Period
Secondary	Change From Baseline in SBM (SBMs/Week) Over 12-week Treatment Period, Mean Replacement Approach	The change from baseline in the number of Spontaneous Bowel Movement (SBM) over the 12-week Treatment Period was assessed. Baseline was the mean number of SBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly SBM totals were derived from the daily diary entries reported during the Treatment Period in the BM and Symptom Diary.	12-Week Treatment Period
Secondary	Change From Baseline in Stool Consistency Score Over the 12-week Treatment Period, Mean Replacement Approach	The stool consistency of each bowel movement (BM) was assessed by patients using the 7-point Bristol Stool Form Scale [BSFS] from 1 to 7.; = separate hard lumps like nuts (difficult to pass); = sausage shaped but lumpy; = like a sausage but with cracks on its surface; = like a sausage or snake, smooth and soft; = soft blobs with clear-cut edges (passed easily); = fluffy pieces with ragged edges, a mushy stool; = watery, no solid pieces (entirely liquid)	12-Week Treatment Period
Secondary	Change From Baseline in Straining Score Over 12-Week Treatment Period, Mean Replacement Approach	Baseline was the mean of non-missing straining scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly average straining score was derived from the straining scores reported during the Treatment Period in the Daily Symptom Diary. The severity of straining during bowel movements was assessed on a 5-point Likert scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.	12-Week Treatment Period