The Plecanatide Chronic Idiopathic Constipation (CIC) Study
- Conditions
- Chronic Idiopathic Constipation
- Interventions
- Other: Placebo
- Registration Number
- NCT01429987
- Lead Sponsor
- Bausch Health Americas, Inc.
- Brief Summary
This is a randomized, double-blind, placebo controlled, 12 week repeat oral dose, dose ranging study to determine the efficacy and safety of 3 doses of plecanatide compared to placebo in patients with Chronic Idiopathic Constipation (CIC).
- Detailed Description
This is a Phase IIb/III, randomized, double-blind, placebo-controlled, 12-Week, Repeat, Oral Dose Ranging, study to determine the safety and efficacy of plecanatide in patients with chronic idiopathic constipation (CIC). Subjects diagnosed with CIC via modified Rome III criteria will be screened against the inclusion and exclusion criteria for the study and enter a 2 Week pre treatment screening. During this phase patients will be required to call in their bowel movements (BM diary) as they occur, and call at least once daily to complete a patient diary of questions on their symptoms (Symptom Diary) associated with CC, as they will throughout the trial. Patients who complete at least 5 days of dosing per week, 6 of each 7 day period of BM diary calls, and continue to have less than 3 complete spontaneous movements per week (as well as meeting other inclusion and exclusion criteria) will be enrolled and randomized to one of three plecanatide doses 0.3 mg, 1.0 mg, and 3.0 mg or placebo. 880 patients will be randomized with the intent of having 200 patients per treatment group (each group the same size) included in efficacy analyses. All subjects receiving at least one dose of plecanatide or matching placebo will be included in the safety analyses.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 951
- Male or female aged 18-75, inclusive
- Body Mass Index = 18-35 kg/m2, inclusive
- Meets modified Rome III criteria for functional chronic idiopathic constipation for at least 3 months with symptom onset for at least 6 months. Note: For this trial, patients with manual maneuvers required for >25% of defecations will not be eligible for participation.
- Less than 3 CSBMs per week at baseline and during pretreatment
- Completed a colonoscopy in accordance with medical guidelines as appropriate, with no clinically significant findings
- Patient is willing to discontinue use of supplemental fiber, laxatives, prescription and nonprescription medications, herbal or dietary supplements intended to treat constipation during the screening, pre-treatment, treatment and 2-week post-treatment periods
- Willing to maintain a stable diet during the study.
- Patients with hemorrhoids and/or diverticulosis (NOT diverticulitis) CAN be entered into the study.
- 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 treatment period
- Patient meets the Rome III criteria for Irritable Bowel Syndrome (IBS-C)
- Active peptic ulcer disease 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 within 60 days of screening.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Placebo Placebo Subjects receive placebo for 12 consecutive weeks plecanatide 3.0 mg plecanatide Subjects receive plecanatide 3.0 mg for 12 consecutive weeks plecanatide 0.3 mg plecanatide Subjects receive plecanatide 0.3 mg for 12 consecutive weeks plecanatide 1.0 mg plecanatide Subjects receive plecanatide 1.0 mg for 12 consecutive weeks
- Primary Outcome Measures
Name Time Method Overall Responder 9/12 Weeks 12-Week Treatment Period A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM and the patient reports a feeling of complete evacuation. A weekly responder will have 3 or more CSBMs and an increase of at least one CSBM from baseline in the same week. An overall responder is a patient who is a weekly responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 weeks.
- Secondary Outcome Measures
Name Time Method Change From Baseline in 12-week CSBM Weekly Frequency Rate 12-Week Treatment Period The number of Complete Spontaneous Bowel Movements (CSBMs) per week
Change From Baseline in 12-week SBM Weekly Frequency Rate 12-Week Treatment Period The number of Spontaneous Bowl Movements experienced per week.
Change From Baseline in Stool Consistency (BSFS) to Over Treatment Period 12-Week Treatment Period 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.
1. = separate hard lumps like nuts (difficult to pass)
2. = sausage shaped but lumpy
3. = like a sausage but with cracks on its surface
4. = like a sausage or snake, smooth and soft
5. = soft blobs with clear-cut edges (passed easily)
6. = fluffy pieces with ragged edges, a mushy stool
7. = watery, no solid pieces (entirely liquid)Change From Baseline in 12-week Patient Reported Symptoms Associated With Constipation - Straining Score 12-Week Treatment Period The severity of straining (Straining Score) was reported by the patients using a 11-point scale (0-10) where 0 = none and 10 = the worst
Trial Locations
- Locations (112)
Southwest Gastroenterology Assoc
🇺🇸Oak Lawn, Illinois, United States
Medex Healthcare Research, Inc.
🇺🇸Chicago, Illinois, United States
Advance Medical Research Service Corp
🇺🇸Miami, Florida, United States
Columbus Clinical Services, LLC
🇺🇸Miami, Florida, United States
South Medical Research Group, Inc
🇺🇸Miami, Florida, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Medical Associates Research Group, Inc.
🇺🇸San Diego, California, United States
Desert Sun Clinical Research, LLC
🇺🇸Tucson, Arizona, United States
Coastal Clinical Research, Inc.
🇺🇸Mobile, Alabama, United States
Preferred Research Partners, Inc
🇺🇸Little Rock, Arkansas, United States
East Valley Gastroenterology and Hepatology Associates, PC
🇺🇸Chandler, Arizona, United States
ACRI-Phase 1,LLC
🇺🇸Anaheim, California, United States
American Center for Clinical Trials
🇺🇸Southfield, Michigan, United States
GW Research, Inc
🇺🇸Chula Vista, California, United States
Translational Research Group, INC., d/b/a Providence Clinical Research
🇺🇸Burbank, California, United States
LeBauer Research Associates, PA
🇺🇸Greensboro, North Carolina, United States
Community Clinical Trials
🇺🇸Orange, California, United States
Dormir Clinical Trials, Inc
🇺🇸Redlands, California, United States
Progressive Clinical Research
🇺🇸Vista, California, United States
North American Partners in Pain Management
🇺🇸Valley Stream, New York, United States
Mid-Atlantic Medical Research Centers
🇺🇸Hollywood, Maryland, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Willis-Knighton Physician Network / Pinnacle Gastroenterology
🇺🇸Shreveport, Louisiana, United States
Synergy First
🇺🇸Brooklyn, New York, United States
NY Total Medical Care
🇺🇸Brooklyn, New York, United States
ClinSearch, LLC
🇺🇸Chattanooga, Tennessee, United States
Memorial Health System, Inc., d/b/a LaPorte Medical Group
🇺🇸LaPorte, Indiana, United States
Mount Vernon Clinical Research, LLC
🇺🇸Sandy Springs, Georgia, United States
Investigators Research Group, LLC
🇺🇸Brownsburg, Indiana, United States
St. Louis Center for Clinical Research
🇺🇸Saint Louis, Missouri, United States
Ridgeview Research
🇺🇸Chaska, Minnesota, United States
Advanced Clinical Research
🇺🇸West Jordan, Utah, United States
Heartland Research Associates, LLC
🇺🇸Wichita, Kansas, United States
Hutchinson Clinic, P.A
🇺🇸Hutchinson, Kansas, United States
Remedica LLC
🇺🇸Rochester, Michigan, United States
Horizon Research Group, LLC
🇺🇸Baton Rouge, Louisiana, United States
Midwest Center for Clinical Research
🇺🇸Lee's Summit, Missouri, United States
Wake Research associates, LLC
🇺🇸Raleigh, North Carolina, United States
Consultants in Gastroenerology
🇺🇸Columbia, South Carolina, United States
MediSpect, LLC
🇺🇸Boone, North Carolina, United States
NECCR Internal Medicine and Cardiology Associates, LLC
🇺🇸Fall River, Massachusetts, United States
Boston Clinical Trials, Inc
🇺🇸Boston, Massachusetts, United States
Valley Medical Research
🇺🇸Centerville, Ohio, United States
Beyer Research
🇺🇸Kalamazoo, Michigan, United States
Medoff Medical / Vital re:Search
🇺🇸Greensboro, North Carolina, United States
Burke Primary Care
🇺🇸Morgantown, North Carolina, United States
Gastroenterology Consultants
🇺🇸Houston, Texas, United States
Quality Research Inc.
🇺🇸San Antonio, Texas, United States
New River Valley Research Institute
🇺🇸Christiansburg, Virginia, United States
Clinical Research Associates, LLC
🇺🇸Oklahoma City, Oklahoma, United States
St. Thomas Medical Group
🇺🇸Nashville, Tennessee, United States
Jean Brown Research
🇺🇸Salt Lake City, Utah, United States
Quality Clinical Research Inc.
🇺🇸Omaha, Nebraska, United States
Meridien Research
🇺🇸Tampa, Florida, United States
Long Island Gastrointestinal Research Group LLP
🇺🇸Great Neck, New York, United States
Premier Medical Group of the Hudson Valley, PC
🇺🇸Poughkeepsie, New York, United States
Paddu and Associates, LLP
🇺🇸Woodside, New York, United States
South Jersey Gastroenterology, PA
🇺🇸Marlton, New Jersey, United States
Reasearch Across America
🇺🇸El Paso, Texas, United States
Jeffrey Danzig
🇺🇸Ridgewood, New Jersey, United States
Inland Gastroenterology Medical Associates, Inc.
🇺🇸Redlands, California, United States
Horizons Clinical Research Center, LLC
🇺🇸Denver, Colorado, United States
Medical Research Unlimited, LLC
🇺🇸Hialeah, Florida, United States
Consultants for Clinical Research of S. Florida
🇺🇸Boynton Beach, Florida, United States
Health Awareness, Inc.
🇺🇸Jupiter, Florida, United States
Nature Coast Clinical Research
🇺🇸Inverness, Florida, United States
Miami Gastroenterology Consultants, PA
🇺🇸Miami, Florida, United States
Advance Medical Research Service
🇺🇸Miami, Florida, United States
Jupiter Research, Inc.
🇺🇸Jupiter, Florida, United States
Florida International Research Center
🇺🇸Miami, Florida, United States
Gold Coast Research, LLC
🇺🇸Plantation, Florida, United States
DMI Research
🇺🇸Seminole, Florida, United States
Gastro Specialists Research Center, LLC
🇺🇸Decatur, Georgia, United States
Rockford Gastroenterology Associates, Ltd.
🇺🇸Rockford, Illinois, United States
MediSphere Medical Research Center, LLC
🇺🇸Evansville, Indiana, United States
Memorial Health System, Inc., d/b/a Ireland Road Medical Group
🇺🇸South Bend, Indiana, United States
Iowa Digestive Disease Center
🇺🇸Clive, Iowa, United States
Gastroenterology Associates, LLC
🇺🇸Baton Rouge, Louisiana, United States
Research Integrity
🇺🇸Owensboro, Kentucky, United States
Clinical Research Institute of Michigan, LLC
🇺🇸Chesterfield, Michigan, United States
PMG Research of Wilmington
🇺🇸Wilmington, North Carolina, United States
Hometown Urgent Care
🇺🇸Groveport, Ohio, United States
Hometown Urgent Care and Research
🇺🇸Springfield, Ohio, United States
PMG Research of Knoxville
🇺🇸Knoxville, Tennessee, United States
KRK Medical Research
🇺🇸Dallas, Texas, United States
Pioneer Research Solutions, Inc.
🇺🇸Houston, Texas, United States
Utah Clinical Trials. LLC
🇺🇸Salt Lake City, Utah, United States
Clinical Research Partners, LLC
🇺🇸Henrico, Virginia, United States
Blue Ridge Medical Research / Gastroenterology Associates of Central Virginia
🇺🇸Lynchburg, Virginia, United States
National Clinical Research-Norfolk, Inc
🇺🇸Norfolk, Virginia, United States
HCCA Clinical Research Solutions
🇺🇸Jackson, Tennessee, United States
CTL Research
🇺🇸Eagle, Idaho, United States
Associates in Gastroenterology
🇺🇸Hermitage, Tennessee, United States
DCOL Center for Clinical Research
🇺🇸Longview, Texas, United States
Superior Research LLC
🇺🇸Sacramento, California, United States
Compass Research, LLC
🇺🇸Orlando, Florida, United States
Women Under Study, LLC
🇺🇸New Orleans, Louisiana, United States
The Center for Pharmaceutical Research, PC
🇺🇸Kansas City, Missouri, United States
Albuquerque Clinical Trials, Inc
🇺🇸Albuquerque, New Mexico, United States
Lovelace Scientific Resources, Inc
🇺🇸Albuquerque, New Mexico, United States
PMG Research of Winston-Salem
🇺🇸Winston-Salem, North Carolina, United States
Clinical and Translational Research Center Hospital
🇺🇸Chapel Hill, North Carolina, United States
National Clinical Research-Richmond, Inc.
🇺🇸Richmond, Virginia, United States
Genova Clinical Research
🇺🇸Tucson, Arizona, United States
Adobe Clinical Research, LLC
🇺🇸Tucson, Arizona, United States
Great Lakes Gastroenterology
🇺🇸Mentor, Ohio, United States
Carolina Digestive Health Associates
🇺🇸Harrisburg, North Carolina, United States
Research Across America
🇺🇸Katy, Texas, United States
Digestive Health Center
🇺🇸Pasadena, Texas, United States
Spring Gastroenterology PA
🇺🇸Spring, Texas, United States
Internal Medical Associates of Grand Island, PC
🇺🇸Grand Island, Nebraska, United States
Central Jersey Medical Research Center
🇺🇸Elizabeth, New Jersey, United States