Irritable Bowel Syndrome Characterized by ConstipationPhase 3IBS-CNCT02387359
The Plecanatide Irritable Bowel Syndrome With Constipation Safety and Efficacy Study (IBS-C)
A Phase 3 study testing Plecanatide in people with Irritable Bowel Syndrome Characterized by Constipation, run by Bausch Health Americas, Inc. at 155 sites in United States.
Trial summary
This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Irritable Bowel Syndrome Characterized by Constipation
- What is being tested?
- Plecanatide
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,054 participants
- Where
- 155 sitesUnited States
- Study dates
- Dec 2014to Feb 2017
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •Adult patients between the ages of 18 and 85 years (inclusive) with a diagnosis of IBS based on ROME III diagnostic criteria and meeting criteria for diagnosis of the constipation predominant subtype - IBS-C
Who cannot join
- Refusal or inability to sign informed consent for the trial
- Refusal or inability to complete daily Episodic (real-time) BM / RM calls, End of Day daily Calls, and/or complete electronic questionnaires
- BMI > 35 or < 18
- Women of child bearing potential who refuse to use an acceptable method of birth control for the duration of the trial
- Women who are pregnant or lactating
- Diagnosis of IBS-D or IBS-M
Show all 12Show fewer
- Organic or obstructive disease of the small or large intestine
- Use of laxatives other than the study-supplied rescue medication (Dulcolax®, bisacodyl)
- Use of a prohibited concomitant medication within the time frame prior to screening outlined in the study protocol for that medication
- Unstable medical illness
- Bilirubin > 3X ULN in the absence of a conjugation defect
- Any laboratory value > 3X ULN unless discussed and approved by the study Medical Monitor
Trial locations and contacts
155 sites in 1 country.
155 sites in 1 country
United States155 sites
Synergy Research Site
Albuquerque, New Mexico, 87108
Synergy Research Site
Alexandria, Virginia, 22304
Synergy Research Site
Anaheim, California, 92801
Synergy Research Site
Arlington, Texas
Synergy Research Site
Artesia, California, 90701
Synergy Research Site
Asheboro, North Carolina, 27203
Synergy Research Site
Athens, Alabama, 35611
Synergy Research Site
Athens, Tennessee, 37303
Synergy Research Site
Atlanta, Georgia, 30328
Synergy Research Site
Augusta, Kansas, 67010
Synergy Research Site
Austin, Texas, 78756
Synergy Research Site
Austin, Texas, 78758
Synergy Research Site
Baltimore, Maryland, 21215
Synergy Research Site
Baton Rouge, Louisiana, 70809
Synergy Research Site
Beavercreek, Ohio, 45440
Synergy Research Site
Bellevue, Washington, 98004
Synergy Research Site
Birmingham, Alabama, 35242
Synergy Research Site
Boston, Massachusetts, 02131
Synergy Research Site
Bountiful, Utah, 84010
Synergy Research Site
Boynton Beach, Florida, 33426
Synergy Research Site
Bradon, Florida, 33511
Synergy Research Site
Bristol, Connecticut, 06010
Synergy Research Site
Brooklyn, New York, 11206
Synergy Research Site
Broomfield, Colorado
Synergy Research Site
Carrolton, Texas, 75010
Synergy Research Site
Cary, North Carolina, 27513
Synergy Research Site
Chandler, Arizona, 85224
Synergy Research Site
Charleston, West Virginia, 25304
Synergy Research Site
Charlotte, North Carolina, 28210
Synergy Research Site
Charlotte, North Carolina, 28277
Synergy Research Site
Charlottesville, Virginia, 22911
Synergy Research Site
Chattanooga, Tennessee, 37404
Synergy Research Site
Chesterfield, Michigan, 48047
Synergy Research Site
Chicago, Illinois, 60611
Synergy Research Site
Chula Vista, California, 91910
Synergy Research Site
Cincinnati, Ohio, 45212
Synergy Research Site
Cleveland, Ohio, 44122
Synergy Research Site
Cleveland, Ohio
Synergy Research Site
Columbia, South Carolina, 29204
Synergy Research Site
Concord, North Carolina, 28025
Synergy Research Site
Conway, Arkansas, 72034
Synergy Research Site
Corona, California, 92879
Synergy Research Site
Crowley, Louisiana, 70526
Synergy Research Site
Dallas, Texas, 75230
Synergy Research Site
Davidson, North Carolina, 28036
Synergy Research Site
DeLand, Florida, 32720
Synergy Research Site
Dothan, Alabama, 36305
Synergy Research Site
Encino, California, 91436
Synergy Research Site
Englewood, Ohio, 45322
Synergy Research Site
Evanston, Illinois, 60201
Synergy Research Site
Evansville, Indiana, 47714
Synergy Research Site
Evergreen Park, Illinois, 60805
Synergy Research Site
Fargo, North Dakota, 58103
Synergy Research Site
Flint, Michigan, 48504
Synergy Research Site
Foley, Alabama, 36535
Synergy Research Site
Fort Lauderdale, Florida, 33308
Synergy Research Site
Fountain Valley, California, 92708
Synergy Research Site
Fresno, California, 93702
Synergy Research Site
Gaffney, South Carolina, 29341
Synergy Research Site
Garden Grove, California, 92840
Synergy Research Site
George, Utah, 84790
Synergy Research Site
Glendale, Arizona, 85308
Synergy Research Site
Great Neck, New York, 11023
Synergy Research Site
Greensboro, North Carolina, 27403
Synergy Research Site.
Greer, South Carolina, 29650
Synergy Research Site
Hagerstown, Maryland, 21742
Synergy Research Site
Hamden, Connecticut, 06518
Synergy Research Site
Hazelwood, Missouri, 63042
Synergy Research Site
Homestead, Florida, 33030
Synergy Research Site
Houston, Texas, 77074
Synergy Research Site
Houston, Texas, 77099
Synergy Research Site
Huntsville, Alabama, 35801
Synergy Research Site
Idaho Falls, Idaho, 83404
Synergy Research Site
Idaho Falls, Idaho
Synergy Research Site
Inverness, Florida, 34452
Synergy Research Site.
Jackson, Mississippi
Synergy Research Site
Jacksonville, Florida, 32205
Synergy Research Site
Kinston, North Carolina, 28501
Synergy Research Site
La Mesa, California, 91942
Synergy Research Site
La Mirada, California, 90638
Synergy Research Site
Laguna Hills, California, 92653
Synergy Research Site
Lancaster, California, 93534
Synergy Research Site
Las Vegas, Nevada, 89119
Synergy Research Site
Lenoir, North Carolina, 28645
Synergy Research Site
Levittown, Pennsylvania, 19056
Synergy Research Site
Little Rock, Arkansas, 72211
Synergy Research Site
Little Rock, Arkansas, 72212
Synergy Research Site
Lynchburg, Virginia, 24502
Synergy Research Site
Mandeville, Louisiana, 70448
Synergy Research Site
Marietta, Georgia, 30060
Synergy Research Site
Marlton, New Jersey, 08053
Synergy Research Site
Memphis, Tennessee, 38119
Synergy Research Site
Metairie, Louisiana, 70006
Synergy Research Site
Miami, Florida, 33144
Synergy Research Site
Miami Lakes, Florida, 33014
Synergy Research Site
Miami Springs, Florida, 33166
Synergy Research Site
Milwaukee, Wisconsin, 53215
Synergy Research Site
Monroe, Louisiana, 71201
Synergy Research Site
Montgomery, Alabama, 36106
Synergy Research Site
Morgantown, West Virginia, 26505
Synergy Research Site.
Nashville, Tennessee, 37211
Synergy Research Site
New Orleans, Louisiana, 70115
Synergy Research Site
New Windsor, New York, 12553
Synergy Research Site
New York, New York, 10016
Synergy Research Site
Newport News, Virginia, 23606
Synergy Research Site
Newton, Kansas, 67114
Synergy Research Site
Norcross, Georgia, 30071
Synergy Research Site
Norcross, Georgia, 30092
Synergy Research Site
North Charleston, South Carolina, 29406
Synergy Research Site
North Hollywood, California, 91606
Synergy Research Site
North Massapequa, New York, 11758
Synergy Research Site
Ogden, Utah, 84405
Synergy Research Site
Oklahoma City, Oklahoma, 73102
Synergy Research Site
Omaha, Nebraska, 68134
Synergy Research Site
Orlando, Florida, 32801
Synergy Research Site
Ormond Beach, Florida, 32174
Synergy Research Site
Oviedo, Florida, 32765
Synergy Research Site
Philadelphia, Pennsylvania, 19152
Synergy Research Site
Phoenix, Arizona, 85018
Synergy Research Site
Pittsburgh, Pennsylvania, 15206
Synergy Research Site
Plano, Texas, 75093
Synergy Research Site
Port Orange, Florida, 32129
Synergy Research Site
Portland, Oregon, 97210
Synergy Research Site
Raleigh, North Carolina, 27612
Synergy Research Site
Rapid City, South Dakota, 57702
Synergy Research Site
Rochester, Michigan, 48307
Synergy Research Site
Rockford, Illinois, 61107
Synergy Research Site
Sacramento, California, 95821
Synergy Research Site
San Antonio, Texas, 78229
Synergy Research Site
San Bernardino, California, 92408
Synergy Research Site
San Diego, California, 92103
Synergy Research Site
Sandy City, Utah, 84092
Synergy Research Site
Shreveport, Louisiana, 71105
Synergy Research Site
Smithfield, Pennsylvania, 15478
Synergy Research Site
Spokane, Washington, 99208
Synergy Research Site
St. Petersburg, Florida, 33709
Synergy Research Site
Stockbridge, Georgia, 30281
Synergy Research Site
Sylvania, Ohio, 43560
Synergy Research Site
Tampa, Florida, 33607
Synergy Research Site
Thousand Oaks, California, 91360
Synergy Research Site
Topeka, Kansas, 66606
Synergy Research Site
Tucson, Arizona, 85710
Synergy Research Site
Tucson, Arizona, 85712
Synergy Research Site
Tulsa, Oklahoma, 74135
Synergy Research Site
Uniontown, Pennsylvania, 15401
Synergy Research Site
Upland, California, 91786
Synergy Research Site
Upland, California
Synergy Research Site
Wauwatosa, Wisconsin, 53226
Synergy Research Site
Webster, Texas, 77598
Synergy Research Site
Wichita, Kansas, 67205
Synergy Research Site
Wichita, Kansas, 67207
Synergy Research Site
Wilmington, North Carolina, 28401
Synergy Research Site
Winston-Salem, North Carolina, 27103
Synergy Research Site
Wyoming, Michigan, 49519
Synergy Research Site.
Yosemite Centennial, Colorado, 80112
About this study
Official title: A Randomized, 12-Week, Double-Blind, Placebo-Controlled Study of the Safety and Efficacy of Plecanatide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)
This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.
Read the detailed description
This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.
Screening/Baseline: Patients will undergo an up to 28-day Screening/Baseline period to allow for any necessary diagnostic procedures, allow for required washout of medications and to determine study eligibility. If otherwise eligible based on screening criteria, patients will undergo a 2-week baseline assessment using an electronic diary where they will record daily assessments of bowel movements (BMs), stool consistency (Bristol Stool Form Scale-BSFS), abdominal pain and other IBS-related symptoms. Data from the two-week electronic diary assessment just prior to the randomization visit will be used to confirm IBS-C and study eligibility as well as define the patient's baseline from which change will be determined.
Treatment: Patients who meet all entry criteria will be randomized (1:1:1) to one of three blinded treatment groups on Day 1 of the Treatment period. Patients will take an oral dose of study drug OD for 12 weeks and continue the daily electronic diaries (BMs, rescue medication use, abdominal pain, and other symptoms). During treatment weeks 4, 8, and 12, patients will return to the clinic to undergo safety and efficacy assessments.
Post-Treatment: For 2 weeks after completing dosing, patients will continue to complete daily electronic diaries. Patients will then return to the clinical site for a final follow-up visit during Week 14 following randomization.
The planned duration of participation in this study will be at least 116 days from signing of informed consent through post-treatment or up to approximately 135 days with visit windows considered.
- Being tested
- Plecanatide, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlecanatideDrug
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| 3.0 mg plecanatide | Active comparator | Plecanatide 3.0 mg dosed daily for 12 weeks Receives: Drug: Plecanatide |
| 6.0 mg plecanatide | Active comparator | Plecanatide 6.0 mg dosed daily for 12 weeks Receives: Drug: Plecanatide |
| Matching placebo | Active comparator | Placebo dosed daily for 12 weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Overall Responders - ITT Population
An Overall Responder was a patient who was a Weekly Responder (i.e., decrease of 30% from baseline for abdominal pain intensity and an increase of at least one complete spontaneous bowel movement in the same week) for at least 6 of the 12 treatment weeks.
Measured: 12 Weeks
Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks
An Abdominal Pain Intensity Responder was a patient who had a decrease of 30% from baseline for abdominal pain intensity. Baseline was the mean of non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.
Measured: 12 Weeks
Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks
A Stool Frequency Responder is defined as a patient who experienced an increase of at least one CSBM (complete spontaneous bowel movement) per week from baseline. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.
Measured: 12 weeks
Secondary outcomes (6)
Number of Sustained Efficacy Responders
A Sustained Efficacy Responder was a patient who was an Overall Responder who also was a Weekly Responder, i.e., decreased of 30% from baseline for abdominal pain intensity and increased of at least one CSBM (complete spontaneous bowel movement) in the same week for at least 2 of the 4 weeks in month 3 of the Treatment Period.
Measured: 12 weeks
Change From Baseline in Stool Consistency
Change from baseline in stool consistency based upon the Bristol Stool Form Scale (BSFS) Rating 1 to 7. Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. BSFS Rating 1 to 7:
- Separate hard lumps, like nuts (hard 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
Measured: Baseline and 12-Week
Change From Baseline in Straining
Change from baseline in Straining Score over the 12-week treatment period. Baseline was the mean of non-missing straining scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The severity of straining during a bowel movement was measured using an 11-point scale (0-10 rating; 0 = no straining; 10 = worst straining).
Measured: Baseline and 12-week
Change From Baseline in CSBM Frequency Rate
Change from baseline over the 12-week Treatment Period in CSBM (Complete Spontaneous Bowel Movement) Frequency Rate (CSBMs/Week). Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.
Measured: Baseline and 12-Week
Number of Patients With a SBM Within 24 Hours After the First Dose
Number of patients with a SBM (spontaneous bowel movement) within 24 hours after the first dose of study drug
Measured: Up to 24 hours after first dose of study drug
Change From Baseline in Abdominal Pain
Change from baseline in abdominal pain as measured with an 11-point (0-10) Numerical Rating Scale from 0 (No) to 10 (Worst Possible). Baseline is the mean of non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.
Measured: Baseline and 12-Week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2015 (estimated)
- Study startDec 2014
- Primary completionDec 2016
- Study completionFeb 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Irritable Bowel Syndrome Characterized by ConstipationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 1,054 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Paul F.C. Eng, PhD, Study director, Synergy Pharmaceuticals Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02387359
- Sponsor's protocol ID
- SP304203-04
- Acronym
- IBS-C
- Status last verified
- Sep 2026
- First submitted
- 20 Jan 2015
- Last updated
- 20 Oct 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Brenner DM, Shin AS, Laitman AP, Deutsch JK, Kunkel DC. The Effectiveness of Plecanatide for Treating Constipation and Bloating in Patients Aged 18 to 40 Years With Irritable Bowel Syndrome: Utilization of a New Composite Trisymptom Endpoint. J Gastroenterol Hepatol. 2025 Dec;40(12):2890-2897. doi: 10.1111/jgh.70119. Epub 2025 Nov 10.
PubMed 41214272Cash BD, Sharma A, Walker A, Laitman AP, Chang L. Plecanatide for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation: Post hoc analyses of placebo-controlled trials in adults with severe constipation. Neurogastroenterol Motil. 2023 Sep;35(9):e14632. doi: 10.1111/nmo.14632. Epub 2023 Jun 18.
PubMed 37332239Menees SB, Franklin H, Chey WD. Evaluation of Plecanatide for the Treatment of Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation in Patients 65 Years or Older. Clin Ther. 2020 Jul;42(7):1406-1414.e4. doi: 10.1016/j.clinthera.2020.05.012. Epub 2020 Jul 10.
PubMed 32660770