Irritable Bowel Syndrome With ConstipationPhase 2(IBS-C)NCT03596905
Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C)
A Phase 2 study testing Plecanatide in people with Irritable Bowel Syndrome With Constipation, run by Bausch Health Americas, Inc. at 35 sites in United States.
Trial summary
The goal of this clinical trial is to learn if plecanatide can improve bowel function and relieve symptoms of irritable bowel syndrome with constipation (IBS-C) in children and adolescents aged 6 to <18 years. Read more about this study
- Who is it for?
- Ages 6 to 18 years
- Conditions the study is for
- Irritable Bowel Syndrome With Constipation
- What is being tested?
- Plecanatide
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 218 participants
- Where
- 35 sitesUnited States
- Study dates
- 30 Jun 2018to 25 Nov 2024
- Phase
- Phase 2
- 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 6 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- A patient will be eligible for study participation if he or she meets all of the following criteria:
- Male or female child or adolescent age 6 to < 18;
- Meets ROME IV criteria for child/adolescent IBS-C defined as:
- For at least 2 months before diagnosis the patient has had:
- Abdominal pain at least 4 days per month associated with one or more of the following:
- Related to defecation
Show all 12Show fewer
- A change in frequency of stool
- A change in form (appearance) of stool;
- The pain does not resolve with resolution of the constipation (children in whom the pain resolves have functional constipation, not irritable bowel syndrome);
- After appropriate evaluation, the symptoms cannot be fully explained by another medical condition
- More than one-fourth (25%) of bowel movements with Bristol stool form types 1 or 2 and less than one-fourth (25%) of bowel movements with Bristol stool form types 6 or 7 on the BSFS or 4 or 5 on the mBSFS-C;
- 3. Patient's parent/guardian/LAR is able to voluntarily provide written, signed, and dated consent and patient is able to voluntarily provide assent as per IRB guidance; 4. Patient and patient's parent/guardian/LAR demonstrates an understanding, ability, and willingness to fully comply with protocol requirements and study procedures (e.g., acceptance of venipuncture, acceptance of urine drug screen for opiates, visit schedule, complete daily electronic diary reporting).
Who cannot join
- A patient will be excluded from the study if he or she meets any of the following criteria:
- The patient has a mental age <4 years in the investigator's opinion;
- The patient has previously been diagnosed with anorectal malformations, neurological deficits, or anatomical anomalies that would constitute a predisposition to constipation;
- The patient currently requires iron supplements, amitriptyline, or other tricyclic antidepressants for depression, opioid-containing medications or compounds for pain, or has other conditions that require medications known to cause constipation. A patient with an onset of constipation prior to the use of these medications and who has been on a stable dose for at least 8 weeks prior to Screening might be considered eligible for this study if the investigator deems these medications do not significantly contribute to the patient's constipation. Screening of these patients needs to be approved by the medical monitor and the sponsor;
- The patient is pregnant or lactating;
- Females age 12 to < 18 or females age 6 to 11 of childbearing potential (defined as post menarche) who does not agree to practice one of the following medically acceptable methods of birth control throughout the study;
Show all 31Show fewer
- Hormonal methods such as oral, implantable, injectable, vaginal ring, or transdermal contraceptives for a minimum of 1 full cycle (based on the patient's usual menstrual cycle period) before study drug administration.
- Total abstinence from sexual intercourse (since the last menses before study drug administration
- Intrauterine device.
- Double-barrier method (condoms, sponge, or diaphragm with spermicidal jellies or cream.
- The patient follows a diet not considered normal by the investigator for the patient's age, relative to variety of food, caloric content, and quantity. The patient must have been on a stable diet for at least 30 days prior to Screening;
- The patient's mobility or normal exercise tolerance is compromised in the investigator's opinion;
- The patient has a history of an eating disorder;
- The patient has clinical or laboratory signs and symptoms of significant cerebral, respiratory, renal, hepatobiliary, pancreatic, intestinal (including acute appendicitis, inflammatory bowel disease, or undiagnosed abdominal pain), endocrinologic, or infectious disease that in the investigator's judgment could interfere with study assessments or completion of the study. (Note: A patient with a history of thyroid disease may be enrolled if he or she has normal T3 and T4 at Screening. If the patient is taking medication for active thyroid disease, his or her T3 and T4 level must be within normal limits and the dose of any medication used to treat it must be stable for at least 30 days prior to Screening);
- The patient has any other medical condition or is receiving concomitant medication or therapy that would in the investigator's opinion compromise his or her safety or compliance with the study protocol or compromise data collection;
- The patient has a history or evidence of drug or alcohol abuse in the 12 months before Screening;
- The patient has a hypersensitivity, allergy, or contraindication to plecanatide;
- The patient has received any experimental drug, including linaclotide and lubiprostone, or experimental therapy within 30 days of study start;
- The patient is unable to tolerate protocol-prescribed rescue medication (Dulcolax®), or unwilling to use it as the only laxative for the duration of the trial;
- The patient has taken a medication considered to be a protocol-defined prohibited prior or concomitant medication or supplement as defined in section 3.3.2;
- The patient and his or her caregiver are unable to communicate well with the study staff and comply with the study requirements (restrictions, appointments, and examination schedule). (The patient/caregiver must be able to complete required Daily BM and Symptom diary entries during the Screening/Baseline period and for the duration of the study. The patient/caregiver must also agree to provide contact information to receive daily reminders should the patient not complete the daily electronic diary entries or require password resets);
- The patient has been screened for or participated in this or another Synergy study in the past;
- The patient has a sibling that is currently participating or has participated in another Synergy study.
- Patient reports having more than 1 loose, mushy stool (Diary-recorded stool consistency of 6 on the Bristol Stool Form Scale (BSFS or 4 on the modified Bristol Stool Form Scale for Children [mBSFSC]) or any watery stool (Diary-recorded stool consistency of 7 on the BSFS or 5 on the mBSFS-C) with any SBM that occurred in the absence of laxative use on the calendar day of the BM or the calendar day before the BM during each 7-day (week) period before the randomization day and up to the day of randomization;
- ≥ 3 CSBMs per week for either week of the 2-week baseline diary assessment immediately preceding the randomization visit;
- > 6 SBMs per week for either week of the 2-week baseline diary assessment immediately preceding the randomization visit;
- Patient reports worst abdominal pain intensity (WAPI) scores in the 2-week baseline diary that meet either of the following:
- WAPI score of 0 on the 11-point Numeric Rating Scale or Wong-Baker Faces® Pain Rating Scale for more than two days during each week of the 2-week baseline diary period.
- An average WAPI < 3 for either of the two weeks of the baseline diary;
- Completion of < 5 of the 7 required daily diary entries in each week of the 2-week baseline diary assessment immediately preceding the randomization visit;
- Use of rescue medication (Dulcolax®, bisacodyl) for more than 2 days during either of the two weeks of the 2-week baseline diary assessment immediately preceding the randomization visit.
Trial locations and contacts
35 sites in 1 country.
35 sites in 1 country
United States35 sites
Bausch Site 145
Akron, Ohio, 44308
Bausch Site 174
Atlanta, Georgia, 30315
Bausch Site 132
Atlanta, Georgia, 30342
Bausch Site 175
Aurora, Colorado, 80012
Bausch Site 195
Austin, Texas, 78723
Bausch Site 146
Bellevue, Washington, 98007
Bausch Site 192
Bowling Green, Kentucky, 42101
Bausch Site 225
Cedar Park, Texas, 78613
Bausch Site 194
Cleveland, Ohio, 44106
Bausch Site 160
Corona, California, 92879
Bausch Site 172
Covington, Louisiana, 70433
Bausch Site 180
Crowley, Louisiana, 70526
Bausch Site 173
Dallas, Texas, 75243
Bausch Site 135
Doral, Florida, 33122
Bausch Site 115
Evansville, Indiana, 47715
Bausch Site 147
Garden Grove, California, 92845
Bausch Site 190
Hialeah, Florida, 33012
Bausch Site 193
Houston, Texas, 77030
Bausch Site 170
Houston, Texas, 77087
Bausch Site 111
Knoxville, Tennessee, 37922
Bausch Site 112
Lafayette, Louisiana, 70508
Bausch Site 142
Los Angeles, California, 90036
Bausch Site 150
Miami, Florida, 33126
Bausch Site 130
Miami, Florida, 33134
Bausch Site 165
Miami, Florida, 33136
Bausch Site 120
Newport News, Virginia, 23606
Bausch Site 220
Omaha, Nebraska, 68134
Bausch Site 140
San Antonio, Texas, 78215
Bausch Site 178
Saraland, Alabama, 36571
Bausch Site 176
Scottsdale, Arizona, 85258
Bausch Site 139
Sioux City, Iowa, 51106
Bausch Site 148
Stockbridge, Georgia, 30281
Bausch Site 110
Tampa, Florida, 33607
Bausch Site 143
Ventura, California, 93003
Bausch Site 197
Washington D.C., District of Columbia, 20016
About this study
Official title: A Randomized, Double-blind, Placebo-Controlled, Dose Ranging, Parallel-Group Study of the Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C)
The goal of this clinical trial is to learn if plecanatide can improve bowel function and relieve symptoms of irritable bowel syndrome with constipation (IBS-C) in children and adolescents aged 6 to <18 years. The main questions it aims to answer are:
- Does plecanatide increase the number of spontaneous bowel movements (SBMs) compared to placebo?
- Is plecanatide safe and well tolerated in this pediatric population? Researchers will compare plecanatide at different doses to a placebo (a look-alike substance with no active drug) to see if plecanatide improves bowel function.
Read more
Participants will:
- Take plecanatide or placebo orally once daily for 4 weeks
- Complete daily symptom diaries
- Attend clinic visits for assessments and safety checks
Read the detailed description
This study is a randomized, double-blind, placebo-controlled, dose-ranging clinical trial designed to evaluate the safety, efficacy, and pharmacokinetics of plecanatide in pediatric patients aged 6 to <18 years with irritable bowel syndrome with constipation (IBS-C). IBS-C is a condition that causes abdominal pain and infrequent, hard bowel movements.
The study includes two age cohorts:
Group A: 6 to 11 years Group B: 12 to <18 years
Participants are randomly assigned to receive one of four plecanatide doses (0.5 mg, 1.0 mg, 2.0 mg, or 3.0 mg) or placebo. All treatments were taken orally once daily for 4 weeks following a 28-day screening/baseline period. After treatment, participants were followed for 2 weeks.
The primary objective is to determine whether plecanatide increases the number of spontaneous bowel movements (SBMs) compared to placebo.
Secondary objectives include:
Time to first bowel movement after starting treatment Changes in stool consistency Changes in abdominal pain and discomfort Overall safety and tolerability of plecanatide
Safety assessments include monitoring adverse events, laboratory tests, and treatment compliance. Participants recorded daily bowel habits and symptoms in an electronic diary and attended scheduled clinic visits for evaluations.
- Being tested
- Plecanatide, Matching placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PlecanatideDrug
Also called Trulance
Taken orally daily for 4 weeks
Matching placeboDrug
Also called No other names
Taken orally daily for 4 weeks
| Study group | Role | What they receive |
|---|---|---|
| 0.5 mg plecanatide | Experimental | Plecanatide 0.5 mg Taken orally once daily for 4 weeks Group A: 6 to 11 years old Receives: Drug: Plecanatide |
| 1.0 mg plecanatide - Group A | Experimental | Plecanatide 1.0 mg Taken orally daily for 4 weeks Group A: 6 to 11 years old Receives: Drug: Plecanatide |
| 2.0 mg plecanatide | Experimental | Plecanatide 2.0 mg Taken orally daily for 4 weeks Group B: 12 to 18 Years of Age Receives: Drug: Plecanatide |
| 3.0 mg plecanatide | Experimental | Plecanatide 3.0 mg Taken orally daily for 4 weeks Group B: 12 to < 18 years old Receives: Drug: Plecanatide |
| Matching placebo - Group A | Placebo comparator | Matching placebo Taken orally daily for 4 weeks Group A: 6 to 11 years old Receives: Drug: Matching placebo |
| 1.0 mg plecanatide - Group B | Experimental | Plecanatide 1.0 mg Taken orally daily for 4 weeks Group B: ≥ 12 to < 18 Years of Age Receives: Drug: Plecanatide |
| Matching Placebo - Group B | Placebo comparator | Matching placebo Taken orally daily for 4 weeks Group B: 12 to < 18 years old Receives: Drug: Matching placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency Over the 4 Week Treatment Period Compared to Placebo and Across Treatment Groups
Weekly SBM rate computed for each week
Measured: Baseline to Week 4
Secondary outcomes (11)
Change From Baseline in Frequency of Abdominal Pain and Abdominal Discomfort Over the 4-week Treatment Period Compared to Placebo and Across Treatment Groups..
Weekly frequency was calculated as the number of abdominal pain episodes and abdominal discomfort episodes per week, based on daily diary entries. Baseline was the average weekly frequency during the 2-week baseline assessment period. Values shown are mean change from baseline (SD).
Measured: Baseline to Week 4
Change From Baseline in Severity of Abdominal Pain and Abdominal Discomfort Over the 4-week Treatment Period Compared to Placebo and Across Treatment Groups..
Severity of abdominal pain and abdominal discomfort was recorded daily using an electronic diary on a 0-10 numeric rating scale (0 = no pain/discomfort; 10 = worst possible). Weekly averages were calculated; baseline was the average score during the 2-week baseline period. Values shown are mean change from baseline.
Measured: Baseline to Week 4
Change From Baseline in Frequency of Complete Spontaneous Bowel Movements (CSBM)
Weekly frequency of complete spontaneous bowel movements (CSBMs) was calculated based on daily diary entries. Baseline was the average weekly frequency during the 2-week baseline period. Values shown are mean change from baseline (SD) at end of 4 weeks of study.
Measured: Baseline to Week 6
Change From Baseline in Frequency of Bowel Movements (BM)
Weekly frequency of bowel movements (BMs) was calculated based on daily diary entries. Baseline was the average weekly frequency during the 2-week baseline period. Values shown are mean change from baseline (SD).
Measured: Baseline to Week 4
Time to First Bowl Movement (in Days)
This outcome was analyzed as a time-to-event variable (time to first complete spontaneous bowel movement), and confidence intervals were estimated using Kaplan-Meier methods.
Measured: Day 1 to first BM during Treatment Period
Change From Baseline in Stool Consistency (Based on Bristol Stool Form Scale, BSFS or Modified Bristol Stool Form Scale for Children, mBSFS-C)
Weekly stool consistency scores based on BSFS (≥12 years) or mBSFS-C (6-11 years). BSFS Scale is a 7 point scale, from Type 1 (Hard to pass) to Type 7 (entirely liquid). mBSFS-C is a 5 point scale, from Type 1 (hard to pass) to Type 5 (watery, no solid pieces).
Measured: Baseline to Week 4
Use of Rescue Medication
Number of rescue medication tablets (Dulcolax® 5 mg) used during the 4-week treatment period. Subjects were instructed to use rescue medication only if ≥72 hours had passed since last bowel movement.
Measured: Baseline to Week 4
Change From Baseline in Frequency of Fecal Incontinence
Weekly fecal incontinence episodes recorded in daily diary.
Measured: Baseline to Week 4
Change From Baseline in Severity of Defecation Pain
Severity of abdominal pain scored daily on a 0-10 numeric rating scale (0 = no pain, 10 = worst possible pain). Weekly averages were calculated from daily scores.
Measured: Baseline to Week 4
Change From Baseline in Frequency of Pain With Defecation
Pain with defecation was recorded in daily diaries as the number of episodes per week. Results represent the mean change from baseline in weekly frequency.
Measured: Baseline to Week 4
Change From Baseline in Frequency of Large Diameter Stools
Weekly frequency of large diameter stools recorded in daily diary.
Measured: Baseline to Week 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2018
- Study start30 Jun 2018
- Primary completion25 Nov 2024
- Study completion25 Nov 2024
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.
- Other trials for Irritable Bowel Syndrome With ConstipationStudies of the same condition, open and under way.
- More trials run by Bausch Health Americas, Inc.The sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 218 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bausch Health Americas, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03596905
- Sponsor's protocol ID
- SP304202-14
- Acronym
- (IBS-C)
- Status last verified
- Nov 2025
- First submitted
- 12 Jul 2018
- Last updated
- 31 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 31 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blind, Placebo-Controlled, Dose Ranging, Parallel-Group Study of the Efficacy and Safety of Plecanatide in Children 6 to <18 Years of Age With Irritable Bowel Syndrome With Constipation (IBS-C)
- ClinicalTrials.gov ID
- NCT03596905
- Acronym / sponsor ID
- (IBS-C) / SP304202-14
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 218 participants (actual)
- Lead sponsor
- Bausch Health Americas, Inc.Industry (pharma, biotech, devices)
- Study start
- 30 Jun 2018 (actual)
- Primary completion
- 25 Nov 2024 (actual)
- Study completion
- 25 Nov 2024 (actual)
- First posted
- 24 Jul 2018 (actual)
- Results
- Posted 31 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The goal of this clinical trial is to learn if plecanatide can improve bowel function and relieve symptoms of irritable bowel syndrome with constipation (IBS-C) in children and adolescents aged 6 to <18 years. The main questions it aims to answer are:
- Does plecanatide increase the number of spontaneous bowel movements (SBMs) compared to placebo?
- Is plecanatide safe and well tolerated in this pediatric population? Researchers will compare plecanatide at different doses to a placebo (a look-alike substance with no active drug) to see if plecanatide improves bowel function.
Participants will:
- Take plecanatide or placebo orally once daily for 4 weeks
- Complete daily symptom diaries
- Attend clinic visits for assessments and safety checks
Detailed description
This study is a randomized, double-blind, placebo-controlled, dose-ranging clinical trial designed to evaluate the safety, efficacy, and pharmacokinetics of plecanatide in pediatric patients aged 6 to <18 years with irritable bowel syndrome with constipation (IBS-C). IBS-C is a condition that causes abdominal pain and infrequent, hard bowel movements.
The study includes two age cohorts:
Group A: 6 to 11 years Group B: 12 to <18 years
Participants are randomly assigned to receive one of four plecanatide doses (0.5 mg, 1.0 mg, 2.0 mg, or 3.0 mg) or placebo. All treatments were taken orally once daily for 4 weeks following a 28-day screening/baseline period. After treatment, participants were followed for 2 weeks.
The primary objective is to determine whether plecanatide increases the number of spontaneous bowel movements (SBMs) compared to placebo.
Secondary objectives include:
Time to first bowel movement after starting treatment Changes in stool consistency Changes in abdominal pain and discomfort Overall safety and tolerability of plecanatide
Safety assessments include monitoring adverse events, laboratory tests, and treatment compliance. Participants recorded daily bowel habits and symptoms in an electronic diary and attended scheduled clinic visits for evaluations.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 7
| Arm | Type | Receives |
|---|---|---|
| 0.5 mg plecanatide | Experimental | Drug: PlecanatidePlecanatide 0.5 mg Taken orally once daily for 4 weeks Group A: 6 to 11 years old |
| 1.0 mg plecanatide - Group A | Experimental | Drug: PlecanatidePlecanatide 1.0 mg Taken orally daily for 4 weeks Group A: 6 to 11 years old |
| 2.0 mg plecanatide | Experimental | Drug: PlecanatidePlecanatide 2.0 mg Taken orally daily for 4 weeks Group B: 12 to 18 Years of Age |
| 3.0 mg plecanatide | Experimental | Drug: PlecanatidePlecanatide 3.0 mg Taken orally daily for 4 weeks Group B: 12 to < 18 years old |
| Matching placebo - Group A | Placebo comparator | Drug: Matching placeboMatching placebo Taken orally daily for 4 weeks Group A: 6 to 11 years old |
| 1.0 mg plecanatide - Group B | Experimental | Drug: PlecanatidePlecanatide 1.0 mg Taken orally daily for 4 weeks Group B: ≥ 12 to < 18 Years of Age |
| Matching Placebo - Group B | Placebo comparator | Drug: Matching placeboMatching placebo Taken orally daily for 4 weeks Group B: 12 to < 18 years old |
Who may qualify
- Ages
- 6 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (12 listed)
- A patient will be eligible for study participation if he or she meets all of the following criteria:
- Male or female child or adolescent age 6 to < 18;
- Meets ROME IV criteria for child/adolescent IBS-C defined as:
- Abdominal pain at least 4 days per month associated with one or more of the following:
- The pain does not resolve with resolution of the constipation (children in whom the pain resolves have functional constipation, not irritable bowel syndrome);
Key exclusion criteria (31 listed)
- A patient will be excluded from the study if he or she meets any of the following criteria:
- The patient has a mental age <4 years in the investigator's opinion;
- The patient has previously been diagnosed with anorectal malformations, neurological deficits, or anatomical anomalies that would constitute a predisposition to constipation;
- The patient currently requires iron supplements, amitriptyline, or other tricyclic antidepressants for depression, opioid-containing medications or compounds for pain, or has other conditions that require medications known to cause constipation. A patient with an onset of constipation prior to the use of these medications and who has been on a stable dose for at least 8 weeks prior to Screening might be considered eligible for this study if the investigator deems these medications do not significantly contribute to the patient's constipation. Screening of these patients needs to be approved by the medical monitor and the sponsor;
- The patient is pregnant or lactating;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| PlecanatideAlso: TrulanceTaken orally daily for 4 weeks | Drug | 0.5 mg plecanatide, 1.0 mg plecanatide - Group A, 1.0 mg plecanatide - Group B, 2.0 mg plecanatide, 3.0 mg plecanatide |
| Matching placeboAlso: No other namesTaken orally daily for 4 weeks | Drug | Matching Placebo - Group B, Matching placebo - Group A |
Primary outcome
Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency Over the 4 Week Treatment Period Compared to Placebo and Across Treatment Groups
Time frame: Baseline to Week 4
Weekly SBM rate computed for each week
11 secondary outcomes
Change From Baseline in Frequency of Abdominal Pain and Abdominal Discomfort Over the 4-week Treatment Period Compared to Placebo and Across Treatment Groups..
Time frame: Baseline to Week 4
Change From Baseline in Severity of Abdominal Pain and Abdominal Discomfort Over the 4-week Treatment Period Compared to Placebo and Across Treatment Groups..
Time frame: Baseline to Week 4
Change From Baseline in Frequency of Complete Spontaneous Bowel Movements (CSBM)
Time frame: Baseline to Week 6
Change From Baseline in Frequency of Bowel Movements (BM)
Time frame: Baseline to Week 4
Time to First Bowl Movement (in Days)
Time frame: Day 1 to first BM during Treatment Period
Change From Baseline in Stool Consistency (Based on Bristol Stool Form Scale, BSFS or Modified Bristol Stool Form Scale for Children, mBSFS-C)
Time frame: Baseline to Week 4
Use of Rescue Medication
Time frame: Baseline to Week 4
Change From Baseline in Frequency of Fecal Incontinence
Time frame: Baseline to Week 4
Change From Baseline in Severity of Defecation Pain
Time frame: Baseline to Week 4
Change From Baseline in Frequency of Pain With Defecation
Time frame: Baseline to Week 4
Change From Baseline in Frequency of Large Diameter Stools
Time frame: Baseline to Week 4
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: Undecided
Related trials for Irritable Bowel Syndrome With Constipation
RecruitingPhase 2
A Study of Brenipatide (LY3537031) in Participants With Irritable Bowel Syndrome-Constipation (IBS-C)
Irritable Bowel Syndrome, Constipation
Not yet recruiting
Acupuncture Combined With Transcutaneous Electrical Acupoint Stimulation for Constipation-Predominant Irritable Bowel Syndrome With Anxiety State
IBS, Constipation Predominant, Anxiety State
Not yet recruitingPhase 3
Rifaximin Treatment in Bloating Predominant Functional Bowel Disorders
Bloating, Rifaximin
RecruitingPhase 2/3
Home Transcutaneous Electrical Acustimulation (TEA)
Irritable Bowel Syndrome With Constipation
Recruiting
A Study of Virtual Reality and Linaclotide for IBS-C
Irritable Bowel Syndrome With Constipation
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
35 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Plecanatide in people with Irritable Bowel Syndrome With Constipation, run by Bausch Health Americas, Inc. at 35 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 12 inclusion and 31 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 31 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 31 Dec 2025). 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?
Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency Over the 4 Week Treatment Period Compared to Placebo and Across Treatment Groups (time frame: Baseline to Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 31 Dec 2025.