The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)
- Conditions
- Irritable Bowel Syndrome Characterized by Constipation
- Interventions
- Drug: Placebo
- Registration Number
- NCT01722318
- Lead Sponsor
- Bausch Health Americas, Inc.
- Brief Summary
This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in patients with IBS-C.
- Detailed Description
This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in patients with IBS-C. Patients will undergo a Screening Period to determine eligibility. After completing a Screening Visit patients will undergo a 2-week Pre-Treatment assessment using the Interactive Voice Response System (IVRS) during which they will complete daily assessments of bowel movements (BMs), stool consistency (Bristol Stool Form Scale- BSFS), abdominal pain or abdominal discomfort and other symptoms associated with IBS-C. Data from the two-week IVRS Pre-treatment assessment are used to define the patient's baseline from which change will be determined. Patients who meet all entry criteria will be randomized to one of five treatment groups ( 0.3mg,1.0mg,3.0mg,9mg,or Placebo) on Day 1 of the Treatment Period. Patients will take an oral dose of study drug daily (QD) for 12 weeks and continue the daily IVRS diaries (BMs, abdominal pain, other symptoms). On Weeks 2, 4, 8, and 12, patients will return to the clinic to undergo safety and efficacy assessments. For 2 weeks after completing dosing, (i.e., Post-Treatment Period), patients will continue to complete daily IVRS diaries. Patients will then return to the clinical site for a final follow-up visit (End of Study Visit). The planned duration of participation in this study will be approximately 112 days from signing of informed consent through post-treatment or 145 days if 30 day washout of a prohibited concomitant medication or stabilization of a medical condition is required before Pre-Treatment (up to 148 days, with all windows considered).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 428
- Male or female aged 18-75, inclusive
- Body Mass Index = 18-35 kg/m2, inclusive
- Meets modified Rome III criteria for irritable bowel syndrome with constipation which includes abdominal pain or discomfort for at least 3 days/month in the last 3 months with symptom onset for at least 6 months.
- Less than 3 CSBMs and less than 6 SBMs per week during the last 3 months.
- Hard or lumpy stools ≥ 25 % of defecations
- Patient has average abdominal pain intensity scores ≥ 3 (scale 0-10)for the combined 2 week pre-treatment period
- 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 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 period
- Patient has diarrhea-predominant or mixed ( diarrhea and constipation cycling or diarrhea and normal cycling) IBS.
- 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: 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 Placebo, one tablet by mouth daily for 12 weeks Plecanatide 0.3mg Plecanatide Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks Plecanatide 1.0mg Plecanatide Plecanatide 1.0mg one tablet by mouth daily for 12 weeks Plecanatide 3.0mg Plecanatide Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks Plecanatide 9.0mg Plecanatide Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks
- Primary Outcome Measures
Name Time Method Change From Baseline in Weekly CSBMs Frequency Over the 12-Week Treatment Period (mITT Population) 12 weeks Treatment Period The primary efficacy endpoint was the change from baseline in the weekly CSBM frequency (CSBMs per week minus CSBMs per week at baseline) over a 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.
- Secondary Outcome Measures
Name Time Method Change From Baseline in Abdominal Pain Intensity Scores Over 12-Week Treatment Period (mITT Population) 12-Week Treatment Period Abdominal Pain was assessed in the patient's daily response on a scale of 0 to 10 where 0 is did not experience the symptom at all and 10 is experienced the worst.
Change From Baseline in Stool Consistency (BSFS) Over 12-Week Treatment Period (mITT Population) 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 Straining Scores Over 12-Week Treatment Period (mITT Population) 12-Week Treatment Period The severity of straining (Straining Score) was rated by the patients using a 11-point scale (0-10) where 0 = none and 10 = very severe
Trial Locations
- Locations (97)
San Marcus Research Clinic, Inc.
🇺🇸Miami, Florida, United States
Genoma Research Group, Inc.
🇺🇸Miami, Florida, United States
South Medical Research Group, Inc.
🇺🇸Miami, Florida, United States
Oklahoma Foundation for Digestive Research
🇺🇸Oklahoma City, Oklahoma, United States
Lynn Health Science Institute
🇺🇸Oklahoma City, Oklahoma, United States
Dartmouth-Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Quality Research, Inc.
🇺🇸San Antonio, Texas, United States
New River Valley Research Institute
🇺🇸Christiansburg, Virginia, United States
Lynn Institute of the Ozarks
🇺🇸Little Rock, Arkansas, United States
Eastern Research, Inc
🇺🇸Hialeah, Florida, United States
Columbus Clinical Services, LLC
🇺🇸Miami, Florida, United States
Gastrointestinal Associates, PA
🇺🇸Jackson, Mississippi, United States
Health Awareness, Inc.
🇺🇸Jupiter, Florida, United States
Urology Center of Florida
🇺🇸Pompano Beach, Florida, United States
Clinical Research of Central Florida
🇺🇸Winter Haven, Florida, United States
CTL Research
🇺🇸Eagle, Idaho, United States
Medex Healthcare Research, Inc
🇺🇸Chicago, Illinois, United States
Centex Studies, Inc.
🇺🇸Houston, Texas, United States
Clinical Research Institute of Michigan, LLC
🇺🇸Chesterfield, Michigan, United States
Heartland Research Associates, LLC
🇺🇸Augusta, Kansas, United States
MGG Group Co., Inc., Chevy Chase Clinical Research
🇺🇸Chevy Chase, Maryland, United States
Center for Digestive Health
🇺🇸Troy, Michigan, United States
Carolina Digestive Health Associates
🇺🇸Davidson, North Carolina, United States
St. Louis Center for Clinical Research
🇺🇸Saint Louis, Missouri, United States
Central Sooner Research
🇺🇸Norman, Oklahoma, United States
Montana Health Research Institute, Inc.
🇺🇸Billings, Montana, United States
MediSpect Medical Research, LLC
🇺🇸Boone, North Carolina, United States
Asheville Gastroenterology Associates, PA
🇺🇸Asheville, North Carolina, United States
Internal Medical Associates of Grand Island, PC
🇺🇸Grand Island, Nebraska, United States
On Site Clinical, LLC
🇺🇸Charlotte, North Carolina, United States
Great Lakes Gastroenterology
🇺🇸Mentor, Ohio, United States
LeBauer Research Associates, P.A.
🇺🇸Greensboro, North Carolina, United States
Clinical Trials of North Carolina, LLC
🇺🇸Cary, North Carolina, United States
Hometown Urgent Care and Occupational Health
🇺🇸Columbus, Ohio, United States
Franklin Gastroenterology, PLLC
🇺🇸Franklin, Tennessee, United States
Consultants in Gastroenterology
🇺🇸Columbia, South Carolina, United States
Texas Tech Medical Center
🇺🇸El Paso, Texas, United States
Physician PrimeCare Research Institute, PLLC dba Health Texas Research Institute
🇺🇸San Antonio, Texas, United States
Pioneer Research Solutions, Inc.
🇺🇸Sugar Land, Texas, United States
Horizons Clinical Research Center, LLC
🇺🇸Denver, Colorado, United States
Medical Center for Clinical Research
🇺🇸San Diego, California, United States
Lynn Institute of the Rockies
🇺🇸Colorado Springs, Colorado, United States
Advanced Research Associates, LLC
🇺🇸Glendale, Arizona, United States
Elite Clinical Trials, LLC
🇺🇸Phoenix, Arizona, United States
SC Clinical Research, Inc.
🇺🇸Garden Grove, California, United States
Advanced Rx Clinical Research, Inc.
🇺🇸Artesia, California, United States
Genova Clinical Research, Inc.
🇺🇸Tucson, Arizona, United States
GW Research, Inc.
🇺🇸Chula Vista, California, United States
Consultants for Clinical Research of South Florida
🇺🇸Boynton Beach, Florida, United States
Meridien Research
🇺🇸Tampa, Florida, United States
Quality Clinical Research, Inc.
🇺🇸Omaha, Nebraska, United States
Memphis Gastroenterology Group, PC
🇺🇸Germantown, Tennessee, United States
Accord Clinical Research, LLC
🇺🇸Port Orange, Florida, United States
Medoff Medical / Vital re:Search
🇺🇸Greensboro, North Carolina, United States
Digestive Health Specialists of the Southeast
🇺🇸Dothan, Alabama, United States
Cahaba Research
🇺🇸Birmingham, Alabama, United States
Adobe Clinical Research, LLC
🇺🇸Tucson, Arizona, United States
Community Clinical Trials
🇺🇸Orange, California, United States
Anaheim Clinical Trials, LLC
🇺🇸Anaheim, California, United States
Healthcare Partners Medical Group
🇺🇸Pasadena, California, United States
Grossmont Center for Clinical Research
🇺🇸La Mesa, California, United States
Jupiter Research, Inc.
🇺🇸Jupiter, Florida, United States
Medical Research Unlimited, LLC
🇺🇸Hialeah, Florida, United States
MNH Surgical Center
🇺🇸Maitland, Florida, United States
Palm Beach Research Center
🇺🇸West Palm Beach, Florida, United States
Mount Vernon Clinical Research, LLC
🇺🇸Sandy Springs, Georgia, United States
Georgia Regents University
🇺🇸Augusta, Georgia, United States
Louisiana Research Center, LLC
🇺🇸Shreveport, Louisiana, United States
Research Integrity, LLC
🇺🇸Owensboro, Kentucky, United States
IHA Chelsea Family & Internal Medicine
🇺🇸Chelsea, Michigan, United States
Novex Clinical Research, LLC
🇺🇸New Bedford, Massachusetts, United States
The Center for Clinical Trials
🇺🇸Biloxi, Mississippi, United States
Prism Research
🇺🇸Saint Paul, Minnesota, United States
St. Luke's Hospital
🇺🇸New York, New York, United States
Cumberland Research Associates, LLC
🇺🇸Fayetteville, North Carolina, United States
Wake Research Associates, LLC
🇺🇸Raleigh, North Carolina, United States
Options Health Research, LLC
🇺🇸Tulsa, Oklahoma, United States
Southeast Medical Research
🇺🇸North Charleston, South Carolina, United States
ClinSearch, LLC
🇺🇸Chattanooga, Tennessee, United States
North Texas Family Medicine
🇺🇸Plano, Texas, United States
Blue Ridge Medical Research/Gastroenterology Associates of Central Virginia
🇺🇸Lynchburg, Virginia, United States
Arrowhead Family Health Center PC dba Arrowhead Health Centers
🇺🇸Glendale, Arizona, United States
Memorial Research Medical Clinic d/b/a Orange Country Research Center
🇺🇸Tustin, California, United States
Chattanooga Medical Research LLC
🇺🇸Chattanooga, Tennessee, United States
Gastroenterology Research of New Orleans
🇺🇸Hammond, Louisiana, United States
Ridgeview Research
🇺🇸Chaska, Minnesota, United States
Delta Research Partners, LLC
🇺🇸Bastrop, Louisiana, United States
Associates in Gastroenterology
🇺🇸Hermitage, Tennessee, United States
Bay State Clinical Trials, Inc.
🇺🇸Watertown, Massachusetts, United States
Palmetto Clinical Research
🇺🇸Summerville, South Carolina, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
Rockford Gastroenterology Associates
🇺🇸Rockford, Illinois, United States
Compass Research, LLC
🇺🇸Orlando, Florida, United States
PMG Research of Winston-Salem, LLC
🇺🇸Winston-Salem, North Carolina, United States
Women Under Study, LLC
🇺🇸New Orleans, Louisiana, United States
Austin Center for Clinical Research
🇺🇸Austin, Texas, United States
DCT-AACT, LLC dba Discovery Clinical Trials
🇺🇸Austin, Texas, United States