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

NCT ID: NCT01982240

Last Updated: 2019-12-26

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

1394 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-11-30

Study Completion Date

2015-06-30

Brief Summary

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

Detailed Description

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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.

Conditions

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Chronic Idiopathic Constipation

Keywords

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CIC Constipation Chronic Constipation Synergy Plecanatide

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Plecanatide 3.0 mg

Plecanatide tablets 3.0 mg QD for 12 weeks

Group Type ACTIVE_COMPARATOR

Plecanatide

Intervention Type DRUG

Plecanatide tablets QD for 12 weeks

Plecanatide 6.0 mg

Plecanatide tablets 6.0 mg QD for 12 weeks

Group Type ACTIVE_COMPARATOR

Plecanatide

Intervention Type DRUG

Plecanatide tablets QD for 12 weeks

Placebo

Matching placebo tablets QD for 12 weeks

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Matching placebo tablets QD for 12 weeks

Bisacodyl

Rescue medication

Group Type OTHER

Bisacodyl

Intervention Type DRUG

Rescue medication

Interventions

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Plecanatide

Plecanatide tablets QD for 12 weeks

Intervention Type DRUG

Placebo

Matching placebo tablets QD for 12 weeks

Intervention Type DRUG

Bisacodyl

Rescue medication

Intervention Type DRUG

Other Intervention Names

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Trulance Trulance placebo Dulcolax

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bausch Health Americas, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mary Beth Layton

Role: STUDY_DIRECTOR

Synergy Pharmaceuticals Inc.

Locations

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Synergy Research Site

Birmingham, Alabama, United States

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Dothan, Alabama, United States

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Gulf Shores, Alabama, United States

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Huntsville, Alabama, United States

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Mobile, Alabama, United States

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Mesa, Arizona, United States

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Phoenix, Arizona, United States

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Phoenix, Arizona, United States

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Tempe, Arizona, United States

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Tucson, Arizona, United States

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Hot Springs, Arkansas, United States

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Little Rock, Arkansas, United States

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North Little Rock, Arkansas, United States

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Anaheim, California, United States

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Anaheim, California, United States

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Carlsbad, California, United States

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Cerritos, California, United States

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Chula Vista, California, United States

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El Cajon, California, United States

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Encinitas, California, United States

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Encino, California, United States

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Fountain Valley, California, United States

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Fresno, California, United States

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Hawaiian Gardens, California, United States

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Lancaster, California, United States

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Long Beach, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Mission Hills, California, United States

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Murrieta, California, United States

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North Hollywood, California, United States

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Oceanside, California, United States

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Oxnard, California, United States

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Pasadena, California, United States

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Poway, California, United States

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Sacramento, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Diego, California, United States

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San Diego, California, United States

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Thousand Oaks, California, United States

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Colorado Springs, Colorado, United States

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Colorado Springs, Colorado, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Denver, Colorado, United States

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Littleton, Colorado, United States

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Bristol, Connecticut, United States

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Danbury, Connecticut, United States

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Waterbury, Connecticut, United States

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Boynton Beach, Florida, United States

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Clearwater, Florida, United States

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DeLand, Florida, United States

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Fort Lauderdale, Florida, United States

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Fort Lauderdale, Florida, United States

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Hialeah, Florida, United States

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Jupiter, Florida, United States

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Lakeland, Florida, United States

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Lynn Haven, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Miami, Florida, United States

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Orlando, Florida, United States

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Orlando, Florida, United States

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Port Orange, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Tampa, Florida, United States

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Athens, Georgia, United States

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Augusta, Georgia, United States

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Decatur, Georgia, United States

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Decatur, Georgia, United States

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Johns Creek, Georgia, United States

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Oakwood, Georgia, United States

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Savannah, Georgia, United States

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Smyrna, Georgia, United States

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Evanston, Illinois, United States

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Clive, Iowa, United States

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Augusta, Kansas, United States

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Newton, Kansas, United States

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Shawnee Mission, Kansas, United States

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Wichita, Kansas, United States

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Wichita, Kansas, United States

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Lexington, Kentucky, United States

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Lexington, Kentucky, United States

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Bastrop, Louisiana, United States

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Marrero, Louisiana, United States

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Metairie, Louisiana, United States

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New Orleans, Louisiana, United States

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New Orleans, Louisiana, United States

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Shreveport, Louisiana, United States

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Chevy Chase, Maryland, United States

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Boston, Massachusetts, United States

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Brockton, Massachusetts, United States

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New Bedford, Massachusetts, United States

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Chesterfield, Michigan, United States

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Flint, Michigan, United States

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Rochester, Michigan, United States

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Saginaw, Michigan, United States

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Southfield, Michigan, United States

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Biloxi, Mississippi, United States

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Jackson, Mississippi, United States

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St Louis, Missouri, United States

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Omaha, Nebraska, United States

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Henderson, Nevada, United States

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Las Vegas, Nevada, United States

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Las Vegas, Nevada, United States

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Reno, Nevada, United States

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Lebanon, New Hampshire, United States

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Lodi, New Jersey, United States

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Ocean City, New Jersey, United States

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Albuquerque, New Mexico, United States

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Brooklyn, New York, United States

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Great Neck, New York, United States

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North Massapequa, New York, United States

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Cary, North Carolina, United States

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Chapel Hill, North Carolina, United States

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Charlotte, North Carolina, United States

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Charlotte, North Carolina, United States

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Greensboro, North Carolina, United States

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Kinston, North Carolina, United States

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Raleigh, North Carolina, United States

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Wilmington, North Carolina, United States

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Winston-Salem, North Carolina, United States

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Fargo, North Dakota, United States

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Beavercreek, Ohio, United States

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Centerville, Ohio, United States

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Cincinnati, Ohio, United States

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Hilliard, Ohio, United States

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Huber Heights, Ohio, United States

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Maumee, Ohio, United States

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Mentor, Ohio, United States

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Oakwood, Ohio, United States

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Stow, Ohio, United States

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Norman, Oklahoma, United States

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Oklahoma City, Oklahoma, United States

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Limerick, Pennsylvania, United States

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Philadelphia, Pennsylvania, United States

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Smithfield, Pennsylvania, United States

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Yardley, Pennsylvania, United States

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Anderson, South Carolina, United States

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Charleston, South Carolina, United States

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Columbia, South Carolina, United States

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Chattanooga, Tennessee, United States

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Jackson, Tennessee, United States

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Nashville, Tennessee, United States

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New Tazewell, Tennessee, United States

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Austin, Texas, United States

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Dallas, Texas, United States

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Dallas, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Houston, Texas, United States

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Killeen, Texas, United States

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Plano, Texas, United States

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San Angelo, Texas, United States

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San Antonio, Texas, United States

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San Antonio, Texas, United States

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Sugar Land, Texas, United States

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Logan, Utah, United States

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Salt Lake City, Utah, United States

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St. George, Utah, United States

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Christiansburg, Virginia, United States

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Henrico, Virginia, United States

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Lynchburg, Virginia, United States

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Norfolk, Virginia, United States

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Norfolk, Virginia, United States

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Richmond, Virginia, United States

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Virginia Beach, Virginia, United States

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Seattle, Washington, United States

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Tacoma, Washington, United States

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Wauwatosa, Wisconsin, United States

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Kelowna, British Columbia, Canada

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Bridgewater, Nova Scotia, Canada

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Brampton, Ontario, Canada

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Cambridge, Ontario, Canada

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Greater Sudbury, Ontario, Canada

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London, Ontario, Canada

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Oshawa, Ontario, Canada

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Toronto, Ontario, Canada

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Toronto, Ontario, Canada

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Mirabel, Quebec, Canada

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Pointe-Claire, Quebec, Canada

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Saint Romuald, Quebec, Canada

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Countries

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United States Canada

References

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Cash BD, Sharma A, Walker A, Laitman AP, Chang L. Plecanatide for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation: Post hoc analyses of placebo-controlled trials in adults with severe constipation. Neurogastroenterol Motil. 2023 Sep;35(9):e14632. doi: 10.1111/nmo.14632. Epub 2023 Jun 18.

Reference Type DERIVED
PMID: 37332239 (View on PubMed)

Rao SSC, Laitman AP, Miner PB Jr. Influence of Demographic Factors on Clinical Outcomes in Adults With Chronic Idiopathic Constipation Treated With Plecanatide. Clin Transl Gastroenterol. 2023 Jul 1;14(7):e00598. doi: 10.14309/ctg.0000000000000598.

Reference Type DERIVED
PMID: 37162147 (View on PubMed)

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.

Reference Type DERIVED
PMID: 35086735 (View on PubMed)

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.

Reference Type DERIVED
PMID: 32660770 (View on PubMed)

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.

Reference Type DERIVED
PMID: 28169285 (View on PubMed)

Other Identifiers

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SP304203-00

Identifier Type: -

Identifier Source: org_study_id