Phase 2
N=218
Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C)
Irritable Bowel Syndrome With Constipation
Bottom Line
View on ClinicalTrials.gov: NCT03596905 ↗Enrolled (actual)
218
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcome: Primary: Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency Over the 4 Week Treatment Period Compared to Placebo and Across Treatment Groups — 0.6; 0.8; 0.6; 1.0 Number of SBMs per week
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Plecanatide (Drug); Matching placebo (Drug)
- Age
- Pediatric, Adult · 6+ yrs
- Sex
- All
- Sponsor
- Bausch Health Americas, Inc.
- Primary completion
- Nov 2024
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency Over the 4 Week Treatment Period Compared to Placebo and Across Treatment Groups |
0.6; 0.8; 0.6; 1.0; 1.1; .70 | — |
| SECONDARY Change From Baseline in Frequency of Abdominal Pain and Abdominal Discomfort Over the 4-week Treatment Period Compared to Placebo and Across Treatment Groups.. |
-2.7; -2.2; -1.4; -1.3; -1.6; -1.4 | — |
| SECONDARY Change From Baseline in Severity of Abdominal Pain and Abdominal Discomfort Over the 4-week Treatment Period Compared to Placebo and Across Treatment Groups.. |
-3.3; -2.3; -2.3; -2.2; -2.8; -2.56 | — |
| SECONDARY Change From Baseline in Frequency of Complete Spontaneous Bowel Movements (CSBM) |
0.7; 0.2; 0.2; 0.4; 0.1; 0.7 | — |
| SECONDARY Change From Baseline in Frequency of Bowel Movements (BM) |
0.5; 0.8; 0.6; 0.8; 1.0; 0.8 | — |
| SECONDARY Time to First Bowl Movement (in Days) |
4.1; 2.58; 5.35; 1.68; 2.05; 2.57 | — |
| SECONDARY Change From Baseline in Stool Consistency (Based on Bristol Stool Form Scale, BSFS or Modified Bristol Stool Form Scale for Children, mBSFS-C) |
1.2; 0.8; 1.2; 1.1; 1.4; 1.9 | — |
| SECONDARY Use of Rescue Medication |
1.3; 0.7; 0.4; 2.4; 0.2; 1.6 | — |
| SECONDARY Change From Baseline in Frequency of Fecal Incontinence |
0.3; 1.9; 1.1; 0.9; 2.3; 1.0 | — |
| SECONDARY Change From Baseline in Severity of Defecation Pain |
-2.4; -2.6; -2.6; -2.3; -2.5; -1.8 | — |
| SECONDARY Change From Baseline in Frequency of Pain With Defecation |
-0.3; -0.8; -0.3; 0.4; -0.5; -0.8 | — |
| SECONDARY Change From Baseline in Frequency of Large Diameter Stools |
0; 0; 0.1; 0.0; -0.1; 0.0 | — |
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
Eligibility Criteria
INCLUSION CRITERIA
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 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.
Data sourced from ClinicalTrials.gov (NCT03596905). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.