The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C) (CIBS)

A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in patients with IBS-C.

Study Overview

• Status: Completed
• Conditions: Irritable Bowel Syndrome Characterized by Constipation
• Intervention / Treatment: Drug: Placebo; Drug: Plecanatide

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).

• Study Type: Interventional
• Enrollment (Actual): 428
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35242
      • Cahaba Research
    • Dothan, Alabama, United States, 36305
      • Digestive Health Specialists of the Southeast
  • Arizona
    • Glendale, Arizona, United States, 85306
      • Arrowhead Family Health Center PC dba Arrowhead Health Centers
    • Glendale, Arizona, United States, 85308
      • Advanced Research Associates, LLC
    • Phoenix, Arizona, United States, 85018
      • Elite Clinical Trials, LLC
    • Tucson, Arizona, United States, 85712
      • Adobe Clinical Research, LLC
    • Tucson, Arizona, United States, 85704
      • Genova Clinical Research, Inc.
  • Arkansas
    • Little Rock, Arkansas, United States, 72205
      • Lynn Institute of the Ozarks
  • California
    • Anaheim, California, United States, 92801
      • Anaheim Clinical Trials, LLC
    • Artesia, California, United States, 90701
      • Advanced Rx Clinical Research, Inc.
    • Chula Vista, California, United States, 91910
      • GW Research, Inc.
    • Garden Grove, California, United States, 92844
      • SC Clinical Research, Inc.
    • La Mesa, California, United States, 91942
      • Grossmont Center for Clinical Research
    • Orange, California, United States, 92868
      • Community Clinical Trials
    • Pasadena, California, United States, 91105
      • HealthCare Partners Medical Group
    • San Diego, California, United States, 92108
      • Medical Center for Clinical Research
    • Tustin, California, United States, 92780
      • Memorial Research Medical Clinic d/b/a Orange Country Research Center
  • Colorado
    • Colorado Springs, Colorado, United States, 80907
      • Lynn Institute Of The Rockies
    • Denver, Colorado, United States, 80220
      • Horizons Clinical Research Center, LLC
  • Florida
    • Boynton Beach, Florida, United States, 33426
      • Consultants for Clinical Research of South Florida
    • Hialeah, Florida, United States, 33012
      • Medical Research Unlimited, Llc
    • Hialeah, Florida, United States, 33013
      • Eastern Research, Inc
    • Jupiter, Florida, United States, 33458
      • Health Awareness, Inc.
    • Jupiter, Florida, United States, 33458
      • Jupiter Research, Inc.
    • Maitland, Florida, United States, 32751
      • MNH Surgical Center
    • Miami, Florida, United States, 33015
      • San Marcus Research Clinic, Inc.
    • Miami, Florida, United States, 33174
      • Columbus Clinical Services, LLC
    • Miami, Florida, United States, 33186
      • South Medical Research Group, Inc.
    • Miami, Florida, United States, 33165
      • Genoma Research Group, Inc.
    • Orlando, Florida, United States, 32806
      • Compass Research, LLC
    • Pompano Beach, Florida, United States, 33060
      • Urology Center Of Florida
    • Port Orange, Florida, United States, 32129
      • Accord Clinical Research, LLC
    • Tampa, Florida, United States, 33606
      • Meridien Research
    • West Palm Beach, Florida, United States, 33409
      • Palm Beach Research Center
    • Winter Haven, Florida, United States, 33880
      • Clinical Research of Central Florida
  • Georgia
    • Augusta, Georgia, United States, 30912
      • Georgia Regents University
    • Sandy Springs, Georgia, United States, 30328
      • Mount Vernon Clinical Research, LLC
  • Idaho
    • Eagle, Idaho, United States, 83616
      • CTL Research
  • Illinois
    • Chicago, Illinois, United States, 60602
      • Medex Healthcare Research, Inc
    • Rockford, Illinois, United States, 61107
      • Rockford Gastroenterology Associates
  • Kansas
    • Augusta, Kansas, United States, 67010
      • Heartland Research Associates, LLC
  • Kentucky
    • Owensboro, Kentucky, United States, 42303
      • Research Integrity, LLC
  • Louisiana
    • Bastrop, Louisiana, United States, 71220
      • Delta Research Partners, LLC
    • Hammond, Louisiana, United States, 70403
      • Gastroenterology Research Of New Orleans
    • Lake Charles, Louisiana, United States, 70601
      • Centex Studies, Inc.
    • New Orleans, Louisiana, United States, 70115
      • Women Under Study, LLC
    • Shreveport, Louisiana, United States, 71103
      • Louisiana Research Center, LLC
  • Maryland
    • Chevy Chase, Maryland, United States, 20815
      • MGG Group Co., Inc., Chevy Chase Clinical Research
  • Massachusetts
    • Boston, Massachusetts, United States, 02131
      • Boston Clinical Trials
    • New Bedford, Massachusetts, United States, 02740
      • Novex Clinical Research, LLC
    • Watertown, Massachusetts, United States, 02472
      • Bay State Clinical Trials, Inc.
  • Michigan
    • Chelsea, Michigan, United States, 48118
      • IHA Chelsea Family & Internal Medicine
    • Chesterfield, Michigan, United States, 48047
      • Clinical Research Institute of Michigan, LLC
    • Troy, Michigan, United States, 48098
      • Center for Digestive Health
  • Minnesota
    • Chaska, Minnesota, United States, 55318
      • Ridgeview Research
    • Saint Paul, Minnesota, United States, 55114
      • Prism Research
  • Mississippi
    • Biloxi, Mississippi, United States, 39531
      • The Center for Clinical Trials
    • Jackson, Mississippi, United States, 39202
      • Gastrointestinal Associates, PA
  • Missouri
    • Saint Louis, Missouri, United States, 63128
      • St. Louis Center for Clinical Research
  • Montana
    • Billings, Montana, United States, 59102
      • Montana Health Research Institute, Inc.
  • Nebraska
    • Grand Island, Nebraska, United States, 68803
      • Internal Medical Associates of Grand Island, PC
    • Omaha, Nebraska, United States, 68114
      • Quality Clinical Research, Inc.
  • New Hampshire
    • Lebanon, New Hampshire, United States, 03756
      • Dartmouth-Hitchcock Medical Center
  • New York
    • New York, New York, United States, 10025
      • St. Luke's Hospital
  • North Carolina
    • Asheville, North Carolina, United States, 28801
      • Asheville Gastroenterology Associates, PA
    • Boone, North Carolina, United States, 28607
      • Medispect Medical Research, Llc
    • Cary, North Carolina, United States, 27518
      • Clinical Trials of North Carolina, LLC
    • Charlotte, North Carolina, United States, 28210
      • Carolina Digestive Health Associates
    • Charlotte, North Carolina, United States, 28277
      • On Site Clinical, LLC
    • Davidson, North Carolina, United States, 28036
      • Carolina Digestive Health Associates
    • Fayetteville, North Carolina, United States, 28304
      • Cumberland Research Associates, LLC
    • Greensboro, North Carolina, United States, 27403
      • LeBauer Research Associates, P.A.
    • Greensboro, North Carolina, United States, 27408
      • Medoff Medical / Vital re:Search
    • Raleigh, North Carolina, United States, 27612
      • Wake Research Associates, LLC
    • Winston-Salem, North Carolina, United States, 27103
      • PMG Research of Winston-Salem, LLC
  • Ohio
    • Columbus, Ohio, United States, 43214
      • Hometown Urgent Care and Occupational Health
    • Mentor, Ohio, United States, 44060
      • Great Lakes Gastroenterology
  • Oklahoma
    • Norman, Oklahoma, United States, 73071
      • Central Sooner Research
    • Oklahoma City, Oklahoma, United States, 73112
      • Lynn Health Science Institute
    • Oklahoma City, Oklahoma, United States, 73104
      • Oklahoma Foundation for Digestive Research
    • Tulsa, Oklahoma, United States, 74104
      • Options Health Research, LLC
  • South Carolina
    • Columbia, South Carolina, United States, 29203
      • Consultants in Gastroenterology
    • North Charleston, South Carolina, United States, 29406
      • Southeast Medical Research
    • Summerville, South Carolina, United States, 29485
      • Palmetto Clinical Research
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • ClinSearch, LLC
    • Chattanooga, Tennessee, United States, 37404
      • Chattanooga Medical Research LLC
    • Franklin, Tennessee, United States, 37067
      • Franklin Gastroenterology, PLLC
    • Germantown, Tennessee, United States, 38138
      • Memphis Gastroenterology Group, PC
    • Hermitage, Tennessee, United States, 37076
      • Associates in Gastroenterology
  • Texas
    • Austin, Texas, United States, 78756
      • Austin Center for Clinical Research
    • Austin, Texas, United States, 78758
      • DCT-AACT, LLC dba Discovery Clinical Trials
    • El Paso, Texas, United States, 79905
      • Texas Tech Medical Center
    • Houston, Texas, United States, 77062
      • Centex Studies, Inc.
    • Plano, Texas, United States, 75093
      • North Texas Family Medicine
    • San Antonio, Texas, United States, 78209
      • Quality Research, Inc.
    • San Antonio, Texas, United States, 78228
      • Physician PrimeCare Research Institute, PLLC dba Health Texas Research Institute
    • Sugar Land, Texas, United States, 77479
      • Pioneer Research Solutions, Inc.
  • Virginia
    • Christiansburg, Virginia, United States, 24073
      • New River Valley Research Institute
    • Lynchburg, Virginia, United States, 24502
      • Blue Ridge Medical Research/Gastroenterology Associates of Central Virginia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Plecanatide 0.3mg; Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks	Drug: Plecanatide; Other Names: Trulance
Active Comparator: Plecanatide 1.0mg; Plecanatide 1.0mg one tablet by mouth daily for 12 weeks	Drug: Plecanatide; Other Names: Trulance
Active Comparator: Plecanatide 3.0mg; Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks	Drug: Plecanatide; Other Names: Trulance
Active Comparator: Plecanatide 9.0mg; Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks	Drug: Plecanatide; Other Names: Trulance
Placebo Comparator: Placebo; Placebo, one tablet by mouth daily for 12 weeks	Drug: Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Weekly CSBMs Frequency Over the 12-Week Treatment Period (mITT Population)	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.	12 weeks Treatment Period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Abdominal Pain Intensity Scores Over 12-Week Treatment Period (mITT Population)	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.	12-Week Treatment Period
Change From Baseline in Stool Consistency (BSFS) Over 12-Week Treatment Period (mITT Population)	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)	12-Week Treatment Period
Change From Baseline in Straining Scores Over 12-Week Treatment Period (mITT Population)	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	12-Week Treatment Period

Collaborators and Investigators

• Sponsor: Bausch Health Americas, Inc.
• Investigators: Principal Investigator: Philip B Miner, MD, Oklahoma Foundation for Digestive Research

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (Actual): April 1, 2014
• Study Completion (Actual): October 1, 2014

Study Registration Dates

• First Submitted: November 2, 2012
• First Submitted That Met QC Criteria: November 5, 2012
• First Posted (Estimate): November 6, 2012

Study Record Updates

• Last Update Posted (Actual): May 28, 2019
• Last Update Submitted That Met QC Criteria: May 23, 2019
• Last Verified: May 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease; Signs and Symptoms, Digestive; Gastrointestinal Diseases; Colonic Diseases, Functional; Colonic Diseases; Intestinal Diseases; Syndrome; Irritable Bowel Syndrome; Constipation; Molecular Mechanisms of Pharmacological Action; Gastrointestinal Agents; Guanylyl Cyclase C Agonists; Enzyme Activators; Plecanatide
• Other Study ID Numbers: SP304-20212