Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C)

NCT03596905 | Completed Phase 2 Results FDA Drug

• 1 other identifier: SP304202-14
• Study Type: interventional
• Target: 218
• Locations: 1 country
• Sites: 35

Brief 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. 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

Conditions

Irritable Bowel Syndrome With Constipation

Outcome Measures

Primary Outcomes (1)

• 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

  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..

  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..

  Baseline to Week 4

• Change From Baseline in Frequency of Complete Spontaneous Bowel Movements (CSBM)

  Baseline to Week 6

• Change From Baseline in Frequency of Bowel Movements (BM)

  Baseline to Week 4

• Time to First Bowl Movement (in Days)

  Day 1 to first BM during Treatment Period

Study Arms (7)

0.5 mg plecanatide

EXPERIMENTAL

Plecanatide 0.5 mg Taken orally once daily for 4 weeks Group A: 6 to 11 years old

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

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

Drug: Plecanatide

3.0 mg plecanatide

EXPERIMENTAL

Plecanatide 3.0 mg Taken orally daily for 4 weeks Group B: 12 to \< 18 years old

Drug: Plecanatide

Matching placebo - Group A

PLACEBO COMPARATOR

Matching placebo Taken orally daily for 4 weeks Group A: 6 to 11 years old

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

Drug: Plecanatide

Matching Placebo - Group B

PLACEBO COMPARATOR

Matching placebo Taken orally daily for 4 weeks Group B: 12 to \< 18 years old

Drug: Matching placebo

Interventions

Plecanatide DRUG

Taken orally daily for 4 weeks

Also known as: Trulance

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 placebo DRUG

Taken orally daily for 4 weeks

Also known as: No other names

Matching Placebo - Group B; Matching placebo - Group A

Eligibility Criteria

• Age: 6 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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
• 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;
• \. 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).

You may not qualify if:

• 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;
• 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;

Sponsors & Collaborators

• Bausch Health Americas, Inc.: lead

Study Sites (35)

Bausch Site 178

Saraland, Alabama, 36571, United States

Location

Bausch Site 176

Scottsdale, Arizona, 85258, United States

Location

Bausch Site 160

Corona, California, 92879, United States

Location

Bausch Site 147

Garden Grove, California, 92845, United States

Location

Bausch Site 142

Los Angeles, California, 90036, United States

Location

Bausch Site 143

Ventura, California, 93003, United States

Location

Bausch Site 175

Aurora, Colorado, 80012, United States

Location

Bausch Site 197

Washington D.C., District of Columbia, 20016, United States

Location

Bausch Site 135

Doral, Florida, 33122, United States

Location

Bausch Site 190

Hialeah, Florida, 33012, United States

Location

Bausch Site 150

Miami, Florida, 33126, United States

Location

Bausch Site 130

Miami, Florida, 33134, United States

Location

Bausch Site 165

Miami, Florida, 33136, United States

Location

Bausch Site 110

Tampa, Florida, 33607, United States

Location

Bausch Site 174

Atlanta, Georgia, 30315, United States

Location

Bausch Site 132

Atlanta, Georgia, 30342, United States

Location

Bausch Site 148

Stockbridge, Georgia, 30281, United States

Location

Bausch Site 115

Evansville, Indiana, 47715, United States

Location

Bausch Site 139

Sioux City, Iowa, 51106, United States

Location

Bausch Site 192

Bowling Green, Kentucky, 42101, United States

Location

Bausch Site 172

Covington, Louisiana, 70433, United States

Location

Bausch Site 180

Crowley, Louisiana, 70526, United States

Location

Bausch Site 112

Lafayette, Louisiana, 70508, United States

Location

Bausch Site 220

Omaha, Nebraska, 68134, United States

Location

Bausch Site 145

Akron, Ohio, 44308, United States

Location

Bausch Site 194

Cleveland, Ohio, 44106, United States

Location

Bausch Site 111

Knoxville, Tennessee, 37922, United States

Location

Bausch Site 195

Austin, Texas, 78723, United States

Location

Bausch Site 225

Cedar Park, Texas, 78613, United States

Location

Bausch Site 173

Dallas, Texas, 75243, United States

Location

Bausch Site 193

Houston, Texas, 77030, United States

Location

Bausch Site 170

Houston, Texas, 77087, United States

Location

Bausch Site 140

San Antonio, Texas, 78215, United States

Location

Bausch Site 120

Newport News, Virginia, 23606, United States

Location

Bausch Site 146

Bellevue, Washington, 98007, United States

Location

MeSH Terms

Interventions

plecanatide

Results Point of Contact

• Title: Angela Moore
• Organization: Bausch Health

angela.moore@bauschhealth.com

843-877-2756

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2018
• First Posted: July 24, 2018
• Study Start: June 30, 2018
• Primary Completion: November 25, 2024
• Study Completion: November 25, 2024
• Last Updated: December 31, 2025
• Results First Posted: December 31, 2025

Record last verified: 2025-11

Locations

US (35)