Phase 2
Completed 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
Source: ClinicalTrials.gov NCT03596905 ↗
Enrolled (actual)
218
Serious AEs
0.0%
Results posted
Dec 2025
Primary outcomePrimary: 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
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
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 | — |
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. Informational only — not medical advice.