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

Chronic Idiopathic Constipation Clinical Trial

— CIC  

Official title:

A National, 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02122471
• Other study ID #: SP304203-03
• Status: Completed
• Phase: Phase 3
• Start date: April 2014
• Est. completion date: July 2015

Study information

• Verified date: May 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 national, 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. 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: 1410
• Est. completion date: July 2015
• Est. primary completion date: May 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 American Gastroenterological Association (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 Bowel Movements (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 myocardial infarction (MI) within 60 days of screening

• Participated in a previous plecanatide clinical trial

Related Conditions & MeSH terms

• Chronic Idiopathic Constipation
• Constipation

Intervention

Drug:
• Plecanatide

• Placebo

Locations

Country	Name	City	State
United States	Synergy Research Site	Albuquerque	New Mexico
United States	Synergy Research Site	Albuquerque	New Mexico
United States	Synergy Research Site	Anaheim	California
United States	Synergy Research Site	Anniston	Alabama
United States	Synergy Research Site	Arlington	Texas
United States	Synergy Research Site	Artesia	California
United States	Synergy Research Site	Atlanta	Georgia
United States	Synergy Research Site	Austin	Texas
United States	Synergy Research Site	Austin	Texas
United States	Synergy Research Site	Austin	Texas
United States	Synergy Research Site	Aventura	Florida
United States	Synergy Research Site	Blackfoot	Idaho
United States	Synergy Research Site	Blackwood	New Jersey
United States	Synergy Research Site	Boise	Idaho
United States	Synergy Research Site	Boynton Beach	Florida
United States	Synergy Research Site	Bradenton	Florida
United States	Synergy Research Site	Brandon	Florida
United States	Synergy Research Site	Bristol	Tennessee
United States	Synergy Research Site	Brooksville	Florida
United States	Synergy Research Site	Buckley	Michigan
United States	Synergy Research Site	Carmichael	California
United States	Synergy Research Site	Carrollton	Texas
United States	Synergy Research Site	Carrollton	Texas
United States	Synergy Research Site	Cary	North Carolina
United States	Synergy Research Site	Chandler	Arizona
United States	Synergy Research Site	Channelview	Texas
United States	Synergy Research Site	Chicago	Illinois
United States	Synergy Research Site	Cincinnati	Ohio
United States	Synergy Research Site	Clearwater	Florida
United States	Synergy Research Site	Cleveland	Ohio
United States	Synergy Research Site	Columbia	Maryland
United States	Synergy Research Site	Columbus	Ohio
United States	Synergy Research Site	Concord	North Carolina
United States	Synergy Research Site	Corona	California
United States	Synergy Research Site	Dallas	Texas
United States	Synergy Research Site	Dallas	Texas
United States	Synergy Research Site	DeLand	Florida
United States	Synergy Research Site	Denver	Colorado
United States	Synergy Research Site	Draper	Utah
United States	Synergy Research Site	Elmsford	New York
United States	Synergy Research Site	Encino	California
United States	Synergy Research Site	Evansville	Indiana
United States	Synergy Research Site	Fort Lauderdale	Florida
United States	Synergy Research Site	Franklin	Tennessee
United States	Synergy Research Site	Gainesville	Florida
United States	Synergy Research Site	Garden Grove	California
United States	Synergy Research Site	Garden Grove	California
United States	Synergy Research Site	Glendale	California
United States	Synergy Research Site	Gonzales	Texas
United States	Synergy Research Site	Goodyear	Arizona
United States	Synergy Research Site	Greer	South Carolina
United States	Synergy Research Site	Hialeah	Florida
United States	Synergy Research Site	Hialeah	Florida
United States	Synergy Research Site	Hialeah	Florida
United States	Synergy Research Site	Hialeah	Florida
United States	Synergy Research Site	Hickory	North Carolina
United States	Synergy Research Site	Hickory	North Carolina
United States	Synergy Research Site	High Point	North Carolina
United States	Synergy Research Site	Hollywood	Florida
United States	Synergy Research Site	Homestead	Florida
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	Huntsville	Alabama
United States	Synergy Research Site	Jacksonville	Florida
United States	Synergy Research Site	Jacksonville	Florida
United States	Synergy Research Site	Jefferson City	Tennessee
United States	Synergy Research Site	Jenkintown	Pennsylvania
United States	Synergy Research Site	Kettering	Ohio
United States	Synergy Research Site	Kingsport	Tennessee
United States	Synergy Research Site	Knoxville	Tennessee
United States	Synergy Research Site	Knoxville	Tennessee
United States	Synergy Research Site	La Mirada	California
United States	Synergy Research Site	Laguna Hills	California
United States	Synergy Research Site	Las Vegas	Nevada
United States	Synergy Research Site	Las Vegas	Nevada
United States	Synergy Research Site	Levittown	Pennsylvania
United States	Synergy Research Site	Littleton	Colorado
United States	Synergy Research Site	Los Angeles	California
United States	Synergy Research Site	Los Angeles	California
United States	Synergy Research Site	Madisonville	Kentucky
United States	Synergy Research Site	Memphis	Tennessee
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	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	Miami	Florida
United States	Synergy Research Site	Miami	Florida
United States	Synergy Research Site	Miami	Florida
United States	Synergy Research Site	Miami Lakes	Florida
United States	Synergy Research Site	Miami Springs	Florida
United States	Synergy Research Site	Middleburg Heights	Ohio
United States	Synergy Research Site	Moncks Corner	South Carolina
United States	Synergy Research Site	Monroe	Louisiana
United States	Synergy Research Site	Nashville	Tennessee
United States	Synergy Research Site	New Hyde Park	New York
United States	Synergy Research Site	New Port Richey	Florida
United States	Synergy Research Site	New York	New York
United States	Synergy Research Site	New York	New York
United States	Synergy Research Site	Newington	New Hampshire
United States	Synergy Research Site	Newport Beach	California
United States	Synergy Research Site	Newport News	Virginia
United States	Synergy Research Site	North Miami Beach	Florida
United States	Synergy Research Site	Oak Lawn	Illinois
United States	Synergy Research Site	Oceanside	California
United States	Synergy Research Site	Oklahoma City	Oklahoma
United States	Synergy Research Site	Oklahoma City	Oklahoma
United States	Synergy Research Site	Omaha	Nebraska
United States	Synergy Research Site	Orange	California
United States	Synergy Research Site	Orlando	Florida
United States	Synergy Research Site	Orlando	Florida
United States	Synergy Research Site	Ormond Beach	Florida
United States	Synergy Research Site	Owensboro	Kentucky
United States	Synergy Research Site	Pembroke Pines	Florida
United States	Synergy Research Site	Pembroke Pines	Florida
United States	Synergy Research Site	Pharr	Texas
United States	Synergy Research Site	Pittsburgh	Pennsylvania
United States	Synergy Research Site	Plano	Texas
United States	Synergy Research Site	Plano	Texas
United States	Synergy Research Site	Plano	Texas
United States	Synergy Research Site	Plano	Texas
United States	Synergy Research Site	Plant City	Florida
United States	Synergy Research Site	Plantation	Florida
United States	Synergy Research Site	Raleigh	North Carolina
United States	Synergy Research Site	Richland	Washington
United States	Synergy Research Site	Sacramento	California
United States	Synergy Research Site	Sacramento	California
United States	Synergy Research Site	Saint Cloud	Florida
United States	Synergy Research Site	Saint Louis	Missouri
United States	Synergy Research Site	Saint Petersburg	Florida
United States	Synergy Research Site	San Antonio	Texas
United States	Synergy Research Site	San Antonio	Texas
United States	Synergy Research Site	San Bernardino	California
United States	Synergy Research Site	San Diego	California
United States	Synergy Research Site	Sarasota	Florida
United States	Synergy Research Site	Savannah	Georgia
United States	Synergy Research Site	Schaumburg	Illinois
United States	Synergy Research Site	Seminole	Florida
United States	Synergy Research Site	Shreveport	Louisiana
United States	Synergy Research Site	Snellville	Georgia
United States	Synergy Research Site	Stamford	Connecticut
United States	Synergy Research Site	Stateline	Nevada
United States	Synergy Research Site	Sterling	Virginia
United States	Synergy Research Site	Sylvania	Ohio
United States	Synergy Research Site	Tamarac	Florida
United States	Synergy Research Site	Tampa	Florida
United States	Synergy Research Site	Tampa	Florida
United States	Synergy Research Site	Tucson	Arizona
United States	Synergy Research Site	Tucson	Arizona
United States	Synergy Research Site	Tucson	Arizona
United States	Synergy Research Site	Tucson	Arizona
United States	Synergy Research Site	Tucson	Arizona
United States	Synergy Research Site	Upland	California
United States	Synergy Research Site	Upper Saint Clair	Pennsylvania
United States	Synergy Research Site	Ventura	California
United States	Synergy Research Site	Wadsworth	Ohio
United States	Synergy Research Site	Watertown	Massachusetts
United States	Synergy Research Site	West Palm Beach	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Bausch Health Americas, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Durable Overall CSBM Responders, Mean Replacement Approach	The primary efficacy endpoint was measured by the number of durable overall CSBM responders over the 12-week Treatment Period. A durable overall CSBM responder was defined as a weekly CSBM responder for at least 9 of the 12 treatment weeks, including 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 the 12-week Treatment Period , Mean Replacement Approach	The change from baseline in the number of Complete Spontaneous Bowel Movements (CSBMs) over the 12-week Treatment Period was analyzed. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. 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.	Baseline and 12 weeks
Secondary	Change From Baseline in SBMs (SBMs/Week) Over the 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 analyzed. 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.	Baseline and 12 weeks
Secondary	Change From Baseline in Average Weekly SBM Stool Consistency Over the 12-week Treatment Period, Mean Replacement Approach	The change from baseline in the stool consistency score (i.e. BSFS) over the 12-week Treatment Period was analyzed. Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly mean BSFS score per patient was derived from the BSFS entries reported during the Treatment Period in the Daily Symptom Diary.; 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)	Baseline and 12 weeks
Secondary	Change From Baseline in Average Weekly Straining Score Over the 12-week Treatment Period, Mean Replacement Approach	The change from baseline in the straining score over the 12-week Treatment Period was analyzed. 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.	Baseline and 12 weeks