The Plecanatide Chronic Idiopathic Constipation (CIC) Study

May 23, 2019 updated by: Bausch Health Americas, Inc.

Study SP304-20210: A Randomized, 12-Week, Double-Blind, Placebo-Controlled, Repeat-Dose, Oral, Dose-Ranging Study to Assess the Safety and Efficacy of Plecanatide in Patients With Chronic Idiopathic Constipation

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

951

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Mobile, Alabama, United States, 36608
        • Coastal Clinical Research, Inc.
    • Arizona
      • Chandler, Arizona, United States, 85224
        • East Valley Gastroenterology and Hepatology Associates, PC
      • Tucson, Arizona, United States, 85704
        • Genova Clinical Research
      • Tucson, Arizona, United States, 85712
        • Adobe Clinical Research, LLC
      • Tucson, Arizona, United States, 85710
        • Desert Sun Clinical Research, LLC
    • Arkansas
      • Little Rock, Arkansas, United States, 72211
        • Preferred Research Partners, Inc
    • California
      • Anaheim, California, United States, 92801
        • ACRI-Phase 1,LLC
      • Burbank, California, United States, 91505
        • Translational Research Group, INC., d/b/a Providence Clinical Research
      • Chula Vista, California, United States, 91910
        • GW Research, Inc
      • Orange, California, United States, 92868
        • Community Clinical Trials
      • Redlands, California, United States, 92374
        • Inland Gastroenterology Medical Associates, Inc.
      • Redlands, California, United States, 92373
        • Dormir Clinical Trials, Inc
      • Sacramento, California, United States, 95825
        • Superior Research LLC
      • San Diego, California, United States, 92123
        • Medical Associates Research Group, Inc.
      • San Diego, California, United States, 92108
        • Medical Center for Clinical Research
      • Vista, California, United States, 92083
        • Progressive Clinical Research
    • Colorado
      • Denver, Colorado, United States, 80220
        • Horizons Clinical Research Center, LLC
    • Florida
      • Boynton Beach, Florida, United States, 33426
        • Consultants for Clinical Research of S. Florida
      • Hialeah, Florida, United States, 33012
        • Medical Research Unlimited, Llc
      • Inverness, Florida, United States, 34452
        • Nature Coast Clinical Research
      • Jupiter, Florida, United States, 33458
        • Health Awareness, Inc.
      • Jupiter, Florida, United States, 33458
        • Jupiter Research, Inc.
      • Miami, Florida, United States, 33174
        • Columbus Clinical Services, LLC
      • Miami, Florida, United States, 33156
        • Miami Gastroenterology Consultants, PA
      • Miami, Florida, United States, 33165
        • Advance Medical Research Service Corp
      • Miami, Florida, United States, 33165
        • Advance Medical Research Service
      • Miami, Florida, United States, 33166
        • Florida International Research Center
      • Miami, Florida, United States, 33186
        • South Medical Research Group, Inc
      • Orlando, Florida, United States, 32806
        • Compass Research, LLC
      • Plantation, Florida, United States, 33317
        • Gold Coast Research, LLC
      • Seminole, Florida, United States, 33777
        • DMI Research
      • Tampa, Florida, United States, 33606
        • Meridien Research
      • West Palm Beach, Florida, United States, 33409
        • Palm Beach Research center
    • Georgia
      • Decatur, Georgia, United States, 30032
        • Gastro Specialists Research Center, LLC
      • Sandy Springs, Georgia, United States, 30328
        • Mount Vernon Clinical Research, LLC
    • Idaho
      • Eagle, Idaho, United States, 83616
        • CTL Research
      • Meridian, Idaho, United States, 83642
        • Advanced Clinical Research
    • Illinois
      • Chicago, Illinois, United States, 60602
        • Medex Healthcare Research, Inc.
      • Oak Lawn, Illinois, United States, 60453
        • Southwest Gastroenterology Assoc
      • Rockford, Illinois, United States, 61107
        • Rockford Gastroenterology Associates, Ltd.
    • Indiana
      • Brownsburg, Indiana, United States, 46112
        • Investigators Research Group, LLC
      • Evansville, Indiana, United States, 47714
        • MediSphere Medical Research Center, LLC
      • LaPorte, Indiana, United States, 46350
        • Memorial Health System, Inc., d/b/a LaPorte Medical Group
      • South Bend, Indiana, United States, 46614
        • Memorial Health System, Inc., d/b/a Ireland Road Medical Group
    • Iowa
      • Clive, Iowa, United States, 50325
        • Iowa Digestive Disease Center
    • Kansas
      • Augusta, Kansas, United States, 67010
        • Heartland Research Associates, LLC
      • Hutchinson, Kansas, United States, 67502
        • Hutchinson Clinic, P.A
      • Newton, Kansas, United States, 67114
        • Heartland Research Associates, LLC
      • Wichita, Kansas, United States, 67205
        • Heartland Research Associates, LLC
      • Wichita, Kansas, United States, 67207
        • Heartland Research Associates, LLC
    • Kentucky
      • Owensboro, Kentucky, United States, 42303
        • Research Integrity
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70809
        • Gastroenterology Associates, Llc
      • Baton Rouge, Louisiana, United States, 70808
        • Horizon Research Group, LLC
      • New Orleans, Louisiana, United States, 70115
        • Women Under Study, LLC
      • Shreveport, Louisiana, United States, 71103
        • Willis-Knighton Physician Network / Pinnacle Gastroenterology
    • Maryland
      • Hollywood, Maryland, United States, 20636
        • Mid-Atlantic Medical Research Centers
    • Massachusetts
      • Boston, Massachusetts, United States, 02135
        • Boston Clinical Trials, Inc
      • Fall River, Massachusetts, United States, 02720
        • NECCR Internal Medicine and Cardiology Associates, LLC
    • Michigan
      • Chesterfield, Michigan, United States, 48047
        • Clinical Research Institute of Michigan, LLC
      • Kalamazoo, Michigan, United States, 49009
        • Beyer Research
      • Rochester, Michigan, United States, 48307
        • Remedica LLC
      • Southfield, Michigan, United States, 48034
        • American Center for Clinical Trials
    • Minnesota
      • Chaska, Minnesota, United States, 55318
        • Ridgeview Research
    • Missouri
      • Kansas City, Missouri, United States, 64114
        • The Center for Pharmaceutical Research, PC
      • Lee's Summit, Missouri, United States, 64064
        • Midwest Center For Clinical Research
      • Saint Louis, Missouri, United States, 63128
        • St. Louis Center for Clinical Research
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Internal Medical Associates of Grand Island, PC
      • Omaha, Nebraska, United States, 68114
        • Quality Clinical Research Inc.
    • New Jersey
      • Elizabeth, New Jersey, United States, 07202
        • Central Jersey Medical Research Center
      • Marlton, New Jersey, United States, 08053
        • South Jersey Gastroenterology, PA
      • Ridgewood, New Jersey, United States, 07450
        • Jeffrey Danzig
    • New Mexico
      • Albuquerque, New Mexico, United States, 87108
        • Lovelace Scientific Resources, Inc
      • Albuquerque, New Mexico, United States, 87102
        • Albuquerque Clinical Trials, Inc
    • New York
      • Brooklyn, New York, United States, 11215
        • NY Total Medical Care
      • Brooklyn, New York, United States, 11230
        • Synergy First
      • Great Neck, New York, United States, 11023
        • Long Island Gastrointestinal Research Group LLP
      • Poughkeepsie, New York, United States, 12601
        • Premier Medical Group of the Hudson Valley, PC
      • Valley Stream, New York, United States, 11580
        • North American Partners in Pain Management
      • Woodside, New York, United States, 11377
        • Paddu and Associates, LLP
    • North Carolina
      • Boone, North Carolina, United States, 28607
        • MediSpect, LLC
      • Chapel Hill, North Carolina, United States, 27599-7600
        • Clinical and Translational Research Center Hospital
      • Charlotte, North Carolina, United States, 28210
        • Carolina Digestive Health Associates
      • Davidson, North Carolina, United States, 28036
        • Carolina Digestive Health Associates
      • Greensboro, North Carolina, United States, 27403
        • LeBauer Research Associates, PA
      • Greensboro, North Carolina, United States, 27408
        • Medoff Medical / Vital re:Search
      • Harrisburg, North Carolina, United States, 28075
        • Carolina Digestive Health Associates
      • Morgantown, North Carolina, United States, 28655
        • Burke Primary Care
      • Raleigh, North Carolina, United States, 27612
        • Wake Research Associates, LLC
      • Wilmington, North Carolina, United States, 28401
        • PMG Research of Wilmington
      • Winston-Salem, North Carolina, United States, 27103
        • PMG Research of Winston-Salem
    • Ohio
      • Centerville, Ohio, United States, 45459
        • Valley Medical Research
      • Columbus, Ohio, United States, 43214
        • Hometown Urgent Care
      • Dayton, Ohio, United States, 45432
        • Hometown Urgent Care and Research
      • Groveport, Ohio, United States, 43125
        • Hometown Urgent Care
      • Mentor, Ohio, United States, 44060
        • Great Lakes Gastroenterology
      • Springfield, Ohio, United States, 45504
        • Hometown Urgent Care and Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Clinical Research Associates, LLC
    • South Carolina
      • Columbia, South Carolina, United States, 29203
        • Consultants in Gastroenerology
    • Tennessee
      • Chattanooga, Tennessee, United States, 37421
        • ClinSearch, LLC
      • Hermitage, Tennessee, United States, 37076
        • Associates in Gastroenterology
      • Jackson, Tennessee, United States, 38305
        • HCCA Clinical Research Solutions
      • Knoxville, Tennessee, United States, 37912
        • PMG Research of Knoxville
      • Nashville, Tennessee, United States, 37205
        • St. Thomas Medical Group
    • Texas
      • Dallas, Texas, United States, 75234
        • Research Across America
      • Dallas, Texas, United States, 75230
        • KRK Medical Research
      • El Paso, Texas, United States, 79902
        • Reasearch Across America
      • Houston, Texas, United States, 77098
        • Pioneer Research Solutions, Inc.
      • Houston, Texas, United States, 77034
        • Gastroenterology Consultants
      • Katy, Texas, United States, 77450
        • Research Across America
      • Longview, Texas, United States, 75605
        • DCOL Center for Clinical Research
      • Pasadena, Texas, United States, 77505
        • Digestive Health Center
      • San Antonio, Texas, United States, 78209
        • Quality Research Inc.
      • Spring, Texas, United States, 77386
        • Spring Gastroenterology PA
    • Utah
      • Salt Lake City, Utah, United States, 84124
        • Jean Brown Research
      • Salt Lake City, Utah, United States, 84107
        • Utah Clinical Trials. LLC
      • West Jordan, Utah, United States, 84088
        • Advanced Clinical Research
    • Virginia
      • Christiansburg, Virginia, United States, 24073
        • New River Valley Research Institute
      • Henrico, Virginia, United States, 23233
        • Clinical Research Partners, LLC
      • Lynchburg, Virginia, United States, 24502
        • Blue Ridge Medical Research / Gastroenterology Associates of Central Virginia
      • Norfolk, Virginia, United States, 23502
        • National Clinical Research-Norfolk, Inc
      • Richmond, Virginia, United States, 23294
        • National Clinical Research-Richmond, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: QUADRUPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: plecanatide 0.3 mg
Subjects receive plecanatide 0.3 mg for 12 consecutive weeks
Drug: plecanatide
Subjects receive experimental study drug for 12 weeks.
Other Names:
  • Trulance
EXPERIMENTAL: plecanatide 1.0 mg
Subjects receive plecanatide 1.0 mg for 12 consecutive weeks
Drug: plecanatide
Subjects receive experimental study drug for 12 weeks.
Other Names:
  • Trulance
EXPERIMENTAL: plecanatide 3.0 mg
Subjects receive plecanatide 3.0 mg for 12 consecutive weeks
Drug: plecanatide
Subjects receive experimental study drug for 12 weeks.
Other Names:
  • Trulance
PLACEBO_COMPARATOR: Placebo
Subjects receive placebo for 12 consecutive weeks
Other: Placebo
Subjects receive experimental study drug for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
12-Week Treatment Period

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
12-Week Treatment Period
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.
12-Week Treatment Period
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)
12-Week Treatment Period
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
12-Week Treatment Period

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Bausch Health Americas, Inc.

Collaborators

Parexel

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2011

Primary Completion (ACTUAL)

December 1, 2012

Study Completion (ACTUAL)

December 1, 2012

Study Registration Dates

First Submitted

September 6, 2011

First Submitted That Met QC Criteria

September 6, 2011

First Posted (ESTIMATE)

September 7, 2011

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

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SP304-20210
  • SP-SP30420210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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