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Irritable Bowel Syndrome Characterized by ConstipationPhase 3IBS-CNCT02493452

Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C)

A Phase 3 study testing Plecanatide in people with Irritable Bowel Syndrome Characterized by Constipation, run by Bausch Health Americas, Inc. at 191 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

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
What is being tested?
Plecanatide
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
1,135 participants
Where
191 sitesUnited States
Study dates
Jun 2015to Feb 2017
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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 ≥ 40 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

191 sites in 1 country.

191 sites in 1 country

United States191 sites

  • Synergy Research Site

    Albuquerque, New Mexico, 87109

  • Synergy Research Site

    Anderson, South Carolina, 29621

  • Synergy Research Site

    Annapolis, Maryland, 21401

  • Synergy Research Site

    Atlanta, Georgia, 30322

  • Synergy Research Site

    Atlanta, Georgia, 30342

  • Synergy Research Site

    Atlantis, Florida, 33462

  • Synergy Research Site

    Austin, Texas, 78731

  • Synergy Research Site

    Austin, Texas, 78758

  • Synergy Research Site

    Baytown, Texas, 77521

  • Synergy Research Site

    Beaumont, Texas, 77701

  • Synergy Research Site

    Birmingham, Alabama, 35209

  • Synergy Research Site

    Birmingham, Alabama, 35216

  • Synergy Research Site

    Blackfoot, Idaho, 83221

  • Synergy Research Site

    Blackwood, New Jersey, 08012

  • Synergy Research Site

    Blue Island, Illinois, 60406

  • Synergy Research Site

    Boca Raton, Florida, 33428

  • Synergy Research Site

    Boise, Idaho, 83709

  • Synergy Research Site

    Bradenton, Florida, 34201

  • Synergy Research Site

    Brandon, Florida, 33511

  • Synergy Research Site

    Brooksville, Florida, 34601

  • Synergy Research Site

    Brownsburg, Indiana, 46112

  • Synergy Research Site

    Canoga Park, California, 91303

  • Synergy Research Site

    Carmichael, California, 95608

  • Synergy Research Site

    Catonsville, Maryland, 21228

  • Synergy Research Site

    Channelview, Texas, 77530

  • Synergy Research Site

    Chapel Hill, North Carolina, 27514

  • Synergy Research Site

    Chesapeake, Virginia, 23320

  • Synergy Research Site

    Chesterfield, Missouri, 63005

  • Synergy Research Site

    Chicago, Illinois, 60602

  • Synergy Research Site

    Chino, California, 91710

  • Synergy Research Site

    Chula Vista, California, 91910

  • Synergy Research Site

    Cincinnati, Ohio, 45224

  • Synergy Research Site

    Cincinnati, Ohio, 45242

  • Synergy Research Site

    Cincinnati, Ohio, 45249

  • Synergy Research Site

    Clearwater, Florida, 33756

  • Synergy Research Site

    Colorado Springs, Colorado, 80920

  • Synergy Research Site

    Columbus, Ohio, 43214

  • Synergy Research Site

    Conway, Arkansas, 72034

  • Synergy Research Site

    Cutler Bay, Florida, 33189

  • Synergy Research Site

    Dallas, Texas, 75224

  • Synergy Research Site

    Dallas, Texas, 75231

  • Synergy Research Site

    Dallas, Texas, 75254

  • Synergy Research Site

    Dayton, Ohio, 45419

  • Synergy Research Site

    Dayton, Ohio, 45439

  • Synergy Research Site

    Decatur, Georgia, 30033

  • Synergy Research Site

    Denver, Colorado, 80246

  • Synergy Research Site

    Doylestown, Pennsylvania, 18901

  • Synergy Research Site

    Egg Harbor, New Jersey, 08234

  • Synergy Research Site

    El Cajon, California, 92020

  • Synergy Research Site

    Encino, California, 91436

  • Synergy Research Site

    Evanston, Illinois, 60201

  • Synergy Research Site

    Fairfax, Virginia, 22031

  • Synergy Research Site

    Fayetteville, North Carolina, 28304

  • Synergy Research Site

    Fayetteville, Tennessee, 37334

  • Synergy Research Site

    Foothill Ranch, California, 92610

  • Synergy Research Site

    Fort Lauderdale, Florida, 33306

  • Synergy Research Site

    Fort Lauderdale, Florida, 33312

  • Synergy Research Site

    Franklin, Ohio, 45005

  • Synergy Research Site

    Franklin, Tennessee, 37067

  • Synergy Research Site

    Garden Grove, California, 92844

  • Synergy Research Site

    Glendale, Arizona, 85301

  • Synergy Research Site

    Greer, South Carolina, 29651

  • Synergy Research Site

    Guntersville, Alabama, 35976

  • Synergy Research Site

    Hamden, Connecticut, 06517

  • Synergy Research Site

    Hermitage, Tennessee, 37076

  • Synergy Research Site

    Hialeah, Florida, 33012

  • Synergy Research Site

    Hialeah, Florida, 33013

  • Synergy Research Site

    Hialeah, Florida, 33016

  • Synergy Research Site

    High Point, North Carolina, 27262

  • Synergy Research Site

    Hoffman Estates, Illinois, 60169

  • Synergy Research Site

    Hopewell Junction, New York, 12533

  • Synergy Research Site

    Houston, Texas, 77008

  • Synergy Research Site

    Houston, Texas, 77081

  • Synergy Research Site

    Humble, Texas, 77338

  • Synergy Research Site

    Huntington Beach, California, 92647

  • Synergy Research Site

    Huntsville, Alabama, 35801

  • Synergy Research Site

    Indianapolis, Indiana, 46237

  • Synergy Research Site

    Irvine, California, 92614

  • Synergy Research Site

    Jackson, Tennessee, 38305

  • Synergy Research Site.

    Jacksonville, Florida, 32256

  • Synergy Research Site

    Jacksonville, North Carolina, 28546

  • Synergy Research Site

    Kalamazoo, Michigan, 49009

  • Synergy Research Site

    Kettering, Ohio, 45429

  • Synergy Research Site

    Kew Gardens, New York, 11415

  • Synergy Research Site

    Kingsport, Tennessee, 37660

  • Synergy Research Site

    Kingwood, West Virginia, 26537

  • Synergy Research Site

    Knoxville, Tennessee, 37909

  • Synergy Research Site

    La Crosse, Wisconsin, 54601

  • Synergy Research Site

    Lampasas, Texas, 76550

  • Synergy Research Site

    Lansdale, Pennsylvania, 19446

  • Synergy Research Site

    Las Vegas, Nevada, 89119

  • Synergy Research Site

    Lauderdale Lakes, Florida, 33319

  • Synergy Research Site

    Levittown, Pennsylvania, 19056

  • Synergy Research Site

    Lilburn, Georgia, 30047

  • Synergy Research Site

    Little Rock, Arkansas, 72205

  • Synergy Research Site

    Lomita, California, 90717

  • Synergy Research Site

    Long Beach, California, 90806

  • Synergy Research Site

    Los Angeles, California, 90045

  • Synergy Research Site

    Madisonville, Kentucky, 42431

  • Synergy Research Site

    Maitland, Florida, 32751

  • Synergy Research Site

    Marietta, Georgia, 30060

  • Synergy Research Site

    Marlborough, Massachusetts, 01752

  • Synergy Research Site

    Marrero, Louisiana, 70072

  • Synergy Research Site

    McKinney, Texas, 75070

  • Synergy Research Site

    Mentor, Ohio, 44060

  • Synergy Research Site

    Meridian, Idaho, 83646

  • Synergy Research Site

    Miami, Florida, 33015

  • Synergy Research Site

    Miami, Florida, 33016

  • Synergy Research Site

    Miami, Florida, 33032

  • Synergy Research Site

    Miami, Florida, 33122

  • Synergy Research Site

    Miami, Florida, 33126

  • Synergy Research Site

    Miami, Florida, 33136

  • Synergy Research Site

    Miami, Florida, 33144

  • Synergy Research Site

    Miami, Florida, 33155

  • Synergy Research Site

    Miami, Florida, 33165

  • Synergy Research Site

    Miami, Florida, 33173

  • Synergy Research Site

    Miami, Florida, 33176

  • Synergy Research Site

    Miami, Florida, 33183

  • Synergy Research Site

    Miami Lakes, Florida, 33016

  • Synergy Research Site

    Miami Lakes, Florida, 33173

  • Synergy Research Site

    Miami Springs, Florida, 33166

  • Synergy Research Site

    Middleburg Heights, Ohio, 44130

  • Synergy Research Site

    Mission Hills, California, 91345

  • Synergy Research Site

    Missoula, Montana, 59808

  • Synergy Research Site

    Missouri City, Texas, 77459

  • Synergy Research Site

    Montclair, California, 91763

  • Synergy Research Site

    Morton, Illinois, 61550

  • Synergy Research Site

    Mt. Pleasant, South Carolina, 29464

  • Synergy Research Site

    Naples, Florida, 34102

  • Synergy Research Site

    New York, New York, 10016

  • Synergy Research Site

    Norfolk, Virginia, 23507

  • Synergy Research Site

    North Miami Beach, Florida, 33162

  • Synergy Research Site

    Northridge, California, 91324

  • Synergy Research Site

    Norwalk, California, 90650

  • Synergy Research Site

    Oak Lawn, Illinois, 60453

  • Synergy Research Site

    Oceanside, California, 92056

  • Synergy Research Site

    Oklahoma City, Oklahoma, 73104

  • Synergy Research Site

    Omaha, Nebraska, 68114

  • Synergy Research Site

    Orange, California, 92868

  • Synergy Research Site

    Orange Park, Florida, 32073

  • Synergy Research Site

    Orangevale, California, 95662

  • Synergy Research Site

    Orem, Utah, 84058

  • Synergy Research Site.

    Orlando, Florida, 32806

  • Synergy Research Site

    Orlando, Florida, 32807

  • Synergy Research Site

    Ormond Beach, Florida, 32174

  • Synergy Research Site

    Owensboro, Kentucky, 42303

  • Synergy Research Site

    Oxon Hill, Maryland, 20745

  • Synergy Research Site

    Pembroke Pines, Florida, 33024

  • Synergy Research Site

    Philadelphia, Pennsylvania, 19140

  • Synergy Research Site

    Phoenix, Arizona, 85018

  • Synergy Research Site

    Pinellas Park, Florida, 33782

  • Synergy Research Site

    Placentia, California, 92870

  • Synergy Research Site

    Plano, Texas, 75024

  • Synergy Research Site

    Plano, Texas, 75075

  • Synergy Research Site

    Port Arthur, Texas, 77640

  • Synergy Research Site

    Port Gibson, Mississippi, 39150

  • Synergy Research Site

    Port Orange, Florida, 32127

  • Synergy Research Site

    Poughkeepsie, New York, 12601

  • Synergy Research Site

    Quincy, Massachusetts, 02169

  • Synergy Research Site

    Raleigh, North Carolina, 27609

  • Synergy Research Site

    Richmond, Virginia, 23220

  • Synergy Research Site

    Richmond, Virginia, 23235

  • Synergy Research Site

    Riverside, California, 92501

  • Synergy Research Site

    Salisbury, North Carolina, 28144

  • Synergy Research Site

    San Antonio, Texas, 78209

  • Synergy Research Site

    San Antonio, Texas, 78215

  • Synergy Research Site

    San Antonio, Texas, 78229

  • Synergy Research Site

    San Diego, California, 92103

  • Synergy Research Site

    San Marino, California, 91108

  • Synergy Research Site

    Santa Ana, California

  • Synergy Research Site

    Saraland, Alabama, 36571

  • Synergy Research Site

    Schaumburg, Illinois, 60194

  • Synergy Research Site

    Sherman Oaks, California, 91403

  • Synergy Research Site

    Snellville, Georgia, 30078

  • Synergy Research Site

    Spokane, Washington, 99202

  • Synergy Research Site

    St Louis, Missouri, 63128

  • Synergy Research Site

    St Louis, Missouri, 63141

  • Synergy Research Site

    Sugar Land, Texas, 77478

  • Synergy Research Site

    Surprise, Arizona, 85374

  • Synergy Research Site

    Tamarac, Florida, 33319

  • Synergy Research Site

    Tampa, Florida, 33613

  • Synergy Research Site

    Tampa, Florida, 33634

  • Synergy Research Site

    Towson, Maryland, 21204

  • Synergy Research Site

    Tucson, Arizona, 85745

  • Synergy Research Site

    Vancouver, Washington, 98664

  • Synergy Research Site

    Vineland, New Jersey, 08360

  • Synergy Research Site

    Wadsworth, Ohio, 44203

  • Synergy Research Site

    West Valley City, Utah, 84120

  • Synergy Research Site

    Wichita, Kansas, 67203

  • Synergy Research Site

    Williston, Florida, 32696

  • Synergy Research Site

    Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: Second Phase 3 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 groups in NCT02493452
Study groupRoleWhat they receive
3.0 mg plecanatideActive comparatorPlecanatide 3.0 mg dosed daily for 12 weeks
Receives: Drug: Plecanatide
6.0 mg plecanatideActive comparatorPlecanatide 6.0 mg dosed daily for 12 weeks
Receives: Drug: Plecanatide
Matching placeboActive comparatorPlacebo 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.

  1. 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 1 complete spontaneous bowel movement in the same week) for at least 6 of the 12 treatment weeks.

    Measured: 12 weeks

  2. 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 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: 12 Weeks

  3. Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks

    A Stool Frequency Responder was 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)

  1. 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

  2. Change From Baseline in Stool Consistency

    Change from baseline in stool consistency based upon the Bristol Stool Form Scale (BSFS). 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:

    1. Separate hard lumps, like nuts (hard 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

    Measured: Baseline and 12-Week

  3. 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

  4. Change From Baseline in CSBMs (CSBMs/Week)Complete Spontaneous Bowel Movement

    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

  5. Number of Patients With a SBM Within 24 Hours After First Dose of Study Medication

    A responder was any patient with a SBM within 24 hours after the first dose of study drug.

    Measured: Up to 24 hours after the first dose of study drug

  6. 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 (None) to 10 (Worst Possible). Baseline was the mean of the non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The average daily abdominal pain score was the average of the non-missing worst daily abdominal pain scores (on a 0 to 10 scale) in the given week.

    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.

  1. First posted9 Jul 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionNov 2016
  4. Study completionFeb 2017

Resources

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
1,135 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02493452
Sponsor's protocol ID
SP304203-05
Acronym
IBS-C
Status last verified
Jun 2019
First submitted
23 Jun 2015
Last updated
14 Jun 2019
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 41214272

  • Cash 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 37332239

  • Menees 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

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Plecanatide in people with Irritable Bowel Syndrome Characterized by Constipation, run by Bausch Health Americas, Inc. at 191 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 191 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 14 Jun 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Overall Responders - ITT Population (time frame: 12 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02493452, which also lists 3 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2019.

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