Trial · NCT03120520

An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation

NCT03120520, Phase 2, Completed, Bausch Health Americas, Inc.; results first posted 2019-09-19

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation. Trials, record NCT03120520. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03120520

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: An Efficacy and Safety Study of Plecanatide in Adolescents 12 to <18 Years of Age With Chronic Idiopathic Constipation
NCT number: NCT03120520
Status: Completed
Phases: Phase 2
Enrollment: 124 participants, actual
Lead sponsor: Bausch Health Americas, Inc.
Conditions: Chronic Idiopathic Constipation
Interventions: Plecanatide, Matching placebo
First posted: 2017-04-19
Last updated: 2019-10-04
Results first posted: 2019-09-19

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Proportion of Overall Responders	8 weeks	An Overall Responder is a participant who was a Spontaneous Bowel Movement (SBM) responder for the last 2 weeks of the Treatment Period. An SBM responder is defined as a participant who had \>3 SBMs per week. SBM was defined as a bowel movement that occurs in the absence of laxative use within the preceding 24 hours. Participants missing with respect to the outcome measure were scored as non-responders.
Secondary	Change From Baseline in Weekly Average Stool Consistency Bristol Stool Form Scale (BSFS) Score	8 weeks	Stool consistency was assessed via the 7-point (1-7) Bristol Stool Form Scale (BSFS) and recorded in the bowel movement (BM) and Symptom Diaries. Lower numbers represent more formed stools; higher numbers represent less formed stools. The weekly mean BSFS score per patient = (total of all BSFS scores reported for a corresponding Spontaneous Bowel Movement (SBM) per time period)/n, where n = number of SBMs scored during the time period. Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. BSFS types were 1) separate hard lumps, like nuts (hard to pass); 2) sausage-shaped but lumpy; 3) like a sausage but with cracks on its surface; 4) like a sausage or snake, smooth and soft; 5) soft blobs with clear-cut edges (passed easily); 6) fluffy pieces with ragged edges, a mushy stool; 7) watery, no solid pieces, entirely liquid.
Secondary	Change From Baseline in the Weekly Rate of Spontaneous Bowel Movements (SBM)	8 weeks	The weekly Spontaneous Bowel Movement (SBM) totals were derived from the daily diary entries reported during the Treatment Period in the Bowel Movement (BM) and symptom diaries. Baseline was the mean number of SBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. SBM is defined as a bowel movement that occurs in the absence of laxative use within the preceding 24 hours
Secondary	Change From Baseline in the Weekly Rate of Complete Spontaneous Bowel Movements (CSBM)	8 weeks	The weekly Complete Spontaneous Bowel Movement (CSBM) totals are derived from the daily diary entries reported during the Treatment Period in the Bowel Movement (BM) and symptom diaries. Baseline is the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. Spontaneous Bowel Movement (SBM) was defined as a bowel movement that occurs in the absence of laxative use within the preceding 24 hours. CSBM was defined as a spontaneous bowel movement with the sense of complete evacuation.

Source ClinicalTrials.gov

Outcomes4

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Proportion of Overall Responders	8 weeks	All randomized participants	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in Weekly Average Stool Consistency Bristol Stool Form Scale (BSFS) Score	8 weeks	All randomized participants	units on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Weekly Rate of Spontaneous Bowel Movements (SBM)	8 weeks	All randomized participants	Weekly SBMs	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in the Weekly Rate of Complete Spontaneous Bowel Movements (CSBM)	8 weeks	All randomized participants	Weekly CSBMs	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group16

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Proportion of Overall Responders	Matching Placebo	7		Participants
Proportion of Overall Responders	Plecanatide 0.5 mg	10		Participants
Proportion of Overall Responders	Plecanatide 1.0 mg	12		Participants
Proportion of Overall Responders	Plecanatide 1.5 mg	7		Participants
Change From Baseline in Weekly Average Stool Consistency Bristol Stool Form Scale (BSFS) Score	Matching Placebo	0.98	Standard Error 0.209	units on a scale
Change From Baseline in Weekly Average Stool Consistency Bristol Stool Form Scale (BSFS) Score	Plecanatide 0.5 mg	1.09	Standard Error 0.209	units on a scale
Change From Baseline in Weekly Average Stool Consistency Bristol Stool Form Scale (BSFS) Score	Plecanatide 1.0 mg	1.22	Standard Error 0.205	units on a scale
Change From Baseline in Weekly Average Stool Consistency Bristol Stool Form Scale (BSFS) Score	Plecanatide 1.5 mg	1.06	Standard Error 0.191	units on a scale
Change From Baseline in the Weekly Rate of Spontaneous Bowel Movements (SBM)	Matching Placebo	1.44	Standard Error 0.332	Weekly SBMs
Change From Baseline in the Weekly Rate of Spontaneous Bowel Movements (SBM)	Plecanatide 0.5 mg	1.97	Standard Error 0.339	Weekly SBMs

1 to 10 of 16Source ClinicalTrials.gov

See all 16 results by group

Participant flow12

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Overall Study	STARTED	Matching Placebo	31
Overall Study	STARTED	Plecanatide 0.5 mg	31
Overall Study	STARTED	Plecanatide 1.0 mg	30
Overall Study	STARTED	Plecanatide 1.5 mg	32
Overall Study	COMPLETED	Matching Placebo	27
Overall Study	COMPLETED	Plecanatide 0.5 mg	27
Overall Study	COMPLETED	Plecanatide 1.0 mg	26
Overall Study	COMPLETED	Plecanatide 1.5 mg	29
Overall Study	NOT COMPLETED	Matching Placebo	4
Overall Study	NOT COMPLETED	Plecanatide 0.5 mg	4

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events64

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
other	Nasopharyngitis	Infections and infestations	Matching Placebo	1	31
other	Nasopharyngitis	Infections and infestations	Plecanatide 0.5 mg	2	31
other	Nasopharyngitis	Infections and infestations	Plecanatide 1.0 mg	2	30
other	Nasopharyngitis	Infections and infestations	Plecanatide 1.5 mg	1	32
other	Acute Tonsillitis	Infections and infestations	Matching Placebo	1	31
other	Acute Tonsillitis	Infections and infestations	Plecanatide 0.5 mg	0	31
other	Acute Tonsillitis	Infections and infestations	Plecanatide 1.0 mg	0	30
other	Acute Tonsillitis	Infections and infestations	Plecanatide 1.5 mg	0	32
other	Bronchitis	Infections and infestations	Matching Placebo	1	31
other	Bronchitis	Infections and infestations	Plecanatide 0.5 mg	0	31

1 to 10 of 64Source ClinicalTrials.gov

See all 64 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Matching Placebo	0	31
Total, all-cause mortality	Plecanatide 0.5 mg	0	31
Total, all-cause mortality	Plecanatide 1.0 mg	0	30
Total, all-cause mortality	Plecanatide 1.5 mg	0	32
Total, other adverse events	Matching Placebo	4	31
Total, other adverse events	Plecanatide 0.5 mg	7	31
Total, other adverse events	Plecanatide 1.0 mg	4	30
Total, other adverse events	Plecanatide 1.5 mg	3	32
Total, serious adverse events	Matching Placebo	0	31
Total, serious adverse events	Plecanatide 0.5 mg	0	31

1 to 10 of 12Source ClinicalTrials.gov

See all 12 adverse event totals

Papers0

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.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

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

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT03120520

GET https://conductscience.org/api/trials/v1/NCT03120520/events?page=2

API reference For AI assistants