DRUG
plecanatide
Subjects receive experimental study drug for 12 weeks.
Status
Completed
Phase
Phase 2 / Phase 3
Enrollment
951
Locations
121
Results
Posted
Publications
0
Study 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).
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.
Interventions
DRUG
Subjects receive experimental study drug for 12 weeks.
OTHER
Subjects receive experimental study drug for 12 weeks.
Timeline
First posted
Sep 7, 2011
Study start
Oct 2011
Primary completion
Dec 2012
Study completion
Dec 2012
Results posted
Nov 29, 2017
Registry updated
May 28, 2019
Outcomes
Overall Responder 9/12 Weeks
Time frame · 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.
Change From Baseline in 12-week CSBM Weekly Frequency Rate
Time frame · 12-Week Treatment Period
The number of Complete Spontaneous Bowel Movements (CSBMs) per week
Change From Baseline in 12-week SBM Weekly Frequency Rate
Time frame · 12-Week Treatment Period
The number of Spontaneous Bowl Movements experienced per week.
Change From Baseline in Stool Consistency (BSFS) to Over Treatment Period
Time frame · 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
Time frame · 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
Eligibility
Inclusion Criteria: * 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. 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 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 locations
United States. Showing up to 24 locations stored in the fast local snapshot.
Coastal Clinical Research, Inc.
Mobile, Alabama, United States
East Valley Gastroenterology and Hepatology Associates, PC
Chandler, Arizona, United States
Genova Clinical Research
Tucson, Arizona, United States
Desert Sun Clinical Research, LLC
Tucson, Arizona, United States
Adobe Clinical Research, LLC
Tucson, Arizona, United States
Preferred Research Partners, Inc
Little Rock, Arkansas, United States
ACRI-Phase 1,LLC
Anaheim, California, United States
Translational Research Group, INC., d/b/a Providence Clinical Research
Burbank, California, United States
GW Research, Inc
Chula Vista, California, United States
Community Clinical Trials
Orange, California, United States
Dormir Clinical Trials, Inc
Redlands, California, United States
Inland Gastroenterology Medical Associates, Inc.
Redlands, California, United States
Superior Research LLC
Sacramento, California, United States
Medical Center for Clinical Research
San Diego, California, United States
Medical Associates Research Group, Inc.
San Diego, California, United States
Progressive Clinical Research
Vista, California, United States
Horizons Clinical Research Center, LLC
Denver, Colorado, United States
Consultants for Clinical Research of S. Florida
Boynton Beach, Florida, United States
Medical Research Unlimited, LLC
Hialeah, Florida, United States
Nature Coast Clinical Research
Inverness, Florida, United States
Health Awareness, Inc.
Jupiter, Florida, United States
Jupiter Research, Inc.
Jupiter, Florida, United States
Miami Gastroenterology Consultants, PA
Miami, Florida, United States
Advance Medical Research Service Corp
Miami, Florida, United States
Publications
No PMID-linked publications were present in this registry snapshot.
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