Trial · NCT03596905
Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C)
NCT03596905, Phase 2, Completed, Bausch Health Americas, Inc.; results first posted 2025-12-31
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C). Trials, record NCT03596905. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03596905
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Plecanatide in Children 6 to <18 Years With Irritable Bowel Syndrome With Constipation (IBS-C)
- NCT number
- NCT03596905
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 218 participants, actual
- Lead sponsor
- Bausch Health Americas, Inc.
- Conditions
- Irritable Bowel Syndrome With Constipation
- Interventions
- Plecanatide, Matching placebo
- First posted
- 2018-07-24
- Last updated
- 2025-12-31
- Results first posted
- 2025-12-31
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency Over the 4 Week Treatment Period Compared to Placebo and Across Treatment Groups | Baseline to Week 4 | Weekly SBM rate computed for each week |
| 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.. | Baseline to Week 4 | 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). |
| 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.. | Baseline to Week 4 | 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. |
| Secondary | Change From Baseline in Frequency of Complete Spontaneous Bowel Movements (CSBM) | Baseline to Week 6 | 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. |
| Secondary | Change From Baseline in Frequency of Bowel Movements (BM) | Baseline to Week 4 | 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). |
| Secondary | Time to First Bowl Movement (in Days) | Day 1 to first BM during Treatment Period | 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. |
| Secondary | Change From Baseline in Stool Consistency (Based on Bristol Stool Form Scale, BSFS or Modified Bristol Stool Form Scale for Children, mBSFS-C) | Baseline to Week 4 | 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). |
| Secondary | Use of Rescue Medication | Baseline to Week 4 | 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. |
| Secondary | Change From Baseline in Frequency of Fecal Incontinence | Baseline to Week 4 | Weekly fecal incontinence episodes recorded in daily diary. |
| Secondary | Change From Baseline in Severity of Defecation Pain | Baseline to Week 4 | 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. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency Over the 4 Week Treatment Period Compared to Placebo and Across Treatment Groups | Baseline to Week 4 | Number of SBMs per week | MEAN | |
| 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.. | Baseline to Week 4 | Episodes per week | MEAN | |
| 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.. | Baseline to Week 4 | Severity score (0-10 scale) | MEAN | |
| SECONDARY | Change From Baseline in Frequency of Complete Spontaneous Bowel Movements (CSBM) | Baseline to Week 6 | Change in Number of CSBMs per week | MEAN | |
| SECONDARY | Change From Baseline in Frequency of Bowel Movements (BM) | Baseline to Week 4 | Number of BMs per week | MEAN | |
| SECONDARY | Time to First Bowl Movement (in Days) | Day 1 to first BM during Treatment Period | Days | MEDIAN | |
| SECONDARY | Change From Baseline in Stool Consistency (Based on Bristol Stool Form Scale, BSFS or Modified Bristol Stool Form Scale for Children, mBSFS-C) | Baseline to Week 4 | Score (BSFS or mBSFS-C) | MEAN | |
| SECONDARY | Use of Rescue Medication | Baseline to Week 4 | Number of Tablets | MEAN | |
| SECONDARY | Change From Baseline in Frequency of Fecal Incontinence | Baseline to Week 4 | Number of episodes per week | MEAN | |
| SECONDARY | Change From Baseline in Severity of Defecation Pain | Baseline to Week 4 | Severity Score 0-10 scale | MEAN |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group98
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency Over the 4 Week Treatment Period Compared to Placebo and Across Treatment Groups | Experimental: 0.5 mg plecanatide | 0.6 | Standard Deviation 2.24 | Number of SBMs per week | |
| Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency Over the 4 Week Treatment Period Compared to Placebo and Across Treatment Groups | Experimental: 1.0 mg plecanatide - Group A | 0.8 | Standard Deviation 1.75 | Number of SBMs per week | |
| Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency Over the 4 Week Treatment Period Compared to Placebo and Across Treatment Groups | Matching placebo - Group A | 0.6 | Standard Deviation 1.53 | Number of SBMs per week | |
| Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency Over the 4 Week Treatment Period Compared to Placebo and Across Treatment Groups | Experimental: 1.0 mg plecanatide - Group B | 1.0 | Standard Deviation 2.08 | Number of SBMs per week | |
| Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency Over the 4 Week Treatment Period Compared to Placebo and Across Treatment Groups | Experimental: 2.0 mg plecanatide | 1.1 | Standard Deviation 2.20 | Number of SBMs per week | |
| Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency Over the 4 Week Treatment Period Compared to Placebo and Across Treatment Groups | Experimental: 3.0 mg plecanatide | .70 | Standard Deviation 2.45 | Number of SBMs per week | |
| Change From Baseline in Weekly Spontaneous Bowel Movement (SBM) Frequency Over the 4 Week Treatment Period Compared to Placebo and Across Treatment Groups | Matching Placebo - Group B | -0.2 | Standard Deviation 1.95 | Number of SBMs per week | |
| Change From Baseline in Frequency of Abdominal Pain and Abdominal Discomfort Over the 4-week Treatment Period Compared to Placebo and Across Treatment Groups.. | Experimental: 0.5 mg plecanatide | Frequency of Abdominal Pain | -2.7 | Standard Deviation 2.27 | Episodes per week |
| Change From Baseline in Frequency of Abdominal Pain and Abdominal Discomfort Over the 4-week Treatment Period Compared to Placebo and Across Treatment Groups.. | Experimental: 1.0 mg plecanatide - Group A | Frequency of Abdominal Pain | -2.2 | Standard Deviation 2.38 | Episodes per week |
| Change From Baseline in Frequency of Abdominal Pain and Abdominal Discomfort Over the 4-week Treatment Period Compared to Placebo and Across Treatment Groups.. | Matching placebo - Group A | Frequency of Abdominal Pain | -1.4 | Standard Deviation 2.47 | Episodes per week |
1 to 10 of 98Source ClinicalTrials.gov
See all 98 results by groupParticipant flow21
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | 0.5 mg Plecanatide | 30 | |
| Overall Study | STARTED | 1.0 mg Plecanatide - Group A | 29 | |
| Overall Study | STARTED | Matching Placebo - Group A | 29 | |
| Overall Study | STARTED | 1.0 mg Plecanatide - Group B | 34 | |
| Overall Study | STARTED | 2.0 mg Plecanatide | 32 | |
| Overall Study | STARTED | 3.0 mg Plecanatide | 32 | |
| Overall Study | STARTED | Matching Placebo - Group B | 32 | |
| Overall Study | COMPLETED | 0.5 mg Plecanatide | 29 | |
| Overall Study | COMPLETED | 1.0 mg Plecanatide - Group A | 26 | |
| Overall Study | COMPLETED | Matching Placebo - Group A | 28 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 participant flowAdverse events147
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Headache | Nervous system disorders | Experimental: 0.5 mg Plecanatide | 0 | 30 | 0 |
| other | Headache | Nervous system disorders | Experimental: 1.0 mg Plecanatide - Group A | 2 | 29 | 2 |
| other | Headache | Nervous system disorders | Matching Placebo - Group A | 0 | 29 | 0 |
| other | Headache | Nervous system disorders | Experimental: 1.0 mg Plecanatide - Group B | 1 | 34 | 1 |
| other | Headache | Nervous system disorders | Experimental: 2.0 mg Plecanatide | 1 | 32 | 1 |
| other | Headache | Nervous system disorders | Experimental: 3.0 mg Plecanatide | 1 | 32 | 1 |
| other | Headache | Nervous system disorders | Matching Placebo - Group B | 1 | 32 | 1 |
| other | Pyrexia | General disorders | Experimental: 0.5 mg Plecanatide | 0 | 30 | 0 |
| other | Pyrexia | General disorders | Experimental: 1.0 mg Plecanatide - Group A | 1 | 29 | 1 |
| other | Pyrexia | General disorders | Matching Placebo - Group A | 0 | 29 | 0 |
1 to 10 of 147Source ClinicalTrials.gov
See all 147 adverse eventsAdverse event totals21
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Experimental: 0.5 mg Plecanatide | 0 | 30 |
| Total, all-cause mortality | Experimental: 1.0 mg Plecanatide - Group A | 0 | 29 |
| Total, all-cause mortality | Matching Placebo - Group A | 0 | 29 |
| Total, all-cause mortality | Experimental: 1.0 mg Plecanatide - Group B | 0 | 34 |
| Total, all-cause mortality | Experimental: 2.0 mg Plecanatide | 0 | 32 |
| Total, all-cause mortality | Experimental: 3.0 mg Plecanatide | 0 | 32 |
| Total, all-cause mortality | Matching Placebo - Group B | 0 | 32 |
| Total, other adverse events | Experimental: 0.5 mg Plecanatide | 2 | 30 |
| Total, other adverse events | Experimental: 1.0 mg Plecanatide - Group A | 5 | 29 |
| Total, other adverse events | Matching Placebo - Group A | 1 | 29 |
1 to 10 of 21Source ClinicalTrials.gov
See all 21 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
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