Trial · NCT01429987

The Plecanatide Chronic Idiopathic Constipation (CIC) Study

NCT01429987, Phase 2, Phase 3, Completed, Bausch Health Americas, Inc.; results first posted 2017-11-29

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. The Plecanatide Chronic Idiopathic Constipation (CIC) Study. Trials, record NCT01429987. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01429987

On this page

Trial

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

Title: The Plecanatide Chronic Idiopathic Constipation (CIC) Study
NCT number: NCT01429987
Status: Completed
Phases: Phase 2, Phase 3
Enrollment: 951 participants, actual
Lead sponsor: Bausch Health Americas, Inc.
Conditions: Chronic Idiopathic Constipation
Interventions: plecanatide, Placebo
First posted: 2011-09-07
Last updated: 2019-05-28
Results first posted: 2017-11-29

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Overall Responder 9/12 Weeks	12-Week Treatment Period	A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM and the patient reports a feeling of complete evacuation. A weekly responder will have 3 or more CSBMs and an increase of at least one CSBM from baseline in the same week. An overall responder is a patient who is a weekly responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 weeks.
Secondary	Change From Baseline in 12-week CSBM Weekly Frequency Rate	12-Week Treatment Period	The number of Complete Spontaneous Bowel Movements (CSBMs) per week
Secondary	Change From Baseline in 12-week SBM Weekly Frequency Rate	12-Week Treatment Period	The number of Spontaneous Bowl Movements experienced per week.
Secondary	Change From Baseline in Stool Consistency (BSFS) to Over Treatment Period	12-Week Treatment Period	The stool consistency of each bowel movement (BM) was assessed by patients using the 7-point Bristol Stool Form Scale \[BSFS\] from 1 to 7. 1. = separate hard lumps like nuts (difficult 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 12-week Patient Reported Symptoms Associated With Constipation - Straining Score	12-Week Treatment Period	The severity of straining (Straining Score) was reported by the patients using a 11-point scale (0-10) where 0 = none and 10 = the worst

Source ClinicalTrials.gov

Outcomes5

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

Type	Outcome	Time frame	Population	Units	Measured as
PRIMARY	Overall Responder 9/12 Weeks	12-Week Treatment Period	The modified Intent-to-Treat (mITT) population is used for all efficacy analyses. The mITT population is all randomized patients who had had at least 1 dose of study drug and who had at least 1 post-baseline BM diary assessment.	% of Overall Responder 9/12 weeks	NUMBER
SECONDARY	Change From Baseline in 12-week CSBM Weekly Frequency Rate	12-Week Treatment Period	The modified Intent-to-Treat (mITT) population is used for all efficacy analyses. The mITT population is all randomized patients who had had at least 1 dose of study drug and who had at least 1 post-baseline BM diary assessment.	CSBMs per week	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in 12-week SBM Weekly Frequency Rate	12-Week Treatment Period	The modified Intent-to-Treat (mITT) population is used for all efficacy analyses. The mITT population is all randomized patients who had had at least 1 dose of study drug and who had at least 1 post-baseline BM diary assessment.	SBMs per week	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in Stool Consistency (BSFS) to Over Treatment Period	12-Week Treatment Period	The modified Intent-to-Treat (mITT) population is used for all efficacy analyses. The mITT population is all randomized patients who had had at least 1 dose of study drug and who had at least 1 post-baseline BM diary assessment.	scores on a scale	LEAST_SQUARES_MEAN
SECONDARY	Change From Baseline in 12-week Patient Reported Symptoms Associated With Constipation - Straining Score	12-Week Treatment Period	The modified Intent-to-Treat (mITT) population is used for all efficacy analyses. The mITT population is all randomized patients who had had at least 1 dose of study drug and who had at least 1 post-baseline BM diary assessment.	scores on a scale	LEAST_SQUARES_MEAN

Source ClinicalTrials.gov

Results by group20

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

Outcome	Group	Value	Spread	Units
Overall Responder 9/12 Weeks	Plecanatide 0.3 mg	18.6		% of Overall Responder 9/12 weeks
Overall Responder 9/12 Weeks	Plecanatide 1.0 mg	16.8		% of Overall Responder 9/12 weeks
Overall Responder 9/12 Weeks	Plecanatide 3.0 mg	19.0		% of Overall Responder 9/12 weeks
Overall Responder 9/12 Weeks	Placebo	10.7		% of Overall Responder 9/12 weeks
Change From Baseline in 12-week CSBM Weekly Frequency Rate	Plecanatide 0.3 mg	1.60	Standard Error 0.159	CSBMs per week
Change From Baseline in 12-week CSBM Weekly Frequency Rate	Plecanatide 1.0 mg	1.81	Standard Error 0.157	CSBMs per week
Change From Baseline in 12-week CSBM Weekly Frequency Rate	Plecanatide 3.0 mg	2.18	Standard Error 0.159	CSBMs per week
Change From Baseline in 12-week CSBM Weekly Frequency Rate	Placebo	1.09	Standard Error 0.162	CSBMs per week
Change From Baseline in 12-week SBM Weekly Frequency Rate	Plecanatide 0.3 mg	2.20	Standard Error 0.190	SBMs per week
Change From Baseline in 12-week SBM Weekly Frequency Rate	Plecanatide 1.0 mg	2.38	Standard Error 0.188	SBMs per week

1 to 10 of 20Source ClinicalTrials.gov

See all 20 results by group

Participant flow12

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Plecanatide 0.3 mg	238
Overall Study	STARTED	Plecanatide 1.0 mg	238
Overall Study	STARTED	Plecanatide 3.0 mg	238
Overall Study	STARTED	Placebo	237
Overall Study	COMPLETED	Plecanatide 0.3 mg	189
Overall Study	COMPLETED	Plecanatide 1.0 mg	176
Overall Study	COMPLETED	Plecanatide 3.0 mg	202
Overall Study	COMPLETED	Placebo	171
Overall Study	NOT COMPLETED	Plecanatide 0.3 mg	49
Overall Study	NOT COMPLETED	Plecanatide 1.0 mg	62

1 to 10 of 12Source ClinicalTrials.gov

See all 12 participant flow

Adverse events68

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	Diarrhoea	Gastrointestinal disorders	Plecanatide 0.3 mg	13	237	13
other	Diarrhoea	Gastrointestinal disorders	Plecanatide 1.0 mg	20	238	21
other	Diarrhoea	Gastrointestinal disorders	Plecanatide 3.0 mg	23	237	24
other	Diarrhoea	Gastrointestinal disorders	Placebo	3	236	3
other	Abdominal Pain	Gastrointestinal disorders	Plecanatide 0.3 mg	6	237	6
other	Abdominal Pain	Gastrointestinal disorders	Plecanatide 1.0 mg	9	238	9
other	Abdominal Pain	Gastrointestinal disorders	Plecanatide 3.0 mg	12	237	15
other	Abdominal Pain	Gastrointestinal disorders	Placebo	11	236	11
other	Nausea	Gastrointestinal disorders	Plecanatide 0.3 mg	5	237	5
other	Nausea	Gastrointestinal disorders	Plecanatide 1.0 mg	12	238	13

1 to 10 of 68Source ClinicalTrials.gov

See all 68 adverse events

Adverse event totals12

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Plecanatide 0.3 mg
Total, all-cause mortality	Plecanatide 1.0 mg
Total, all-cause mortality	Plecanatide 3.0 mg
Total, all-cause mortality	Placebo
Total, other adverse events	Plecanatide 0.3 mg	55	237
Total, other adverse events	Plecanatide 1.0 mg	79	238
Total, other adverse events	Plecanatide 3.0 mg	92	237
Total, other adverse events	Placebo	45	236
Total, serious adverse events	Plecanatide 0.3 mg	1	237
Total, serious adverse events	Plecanatide 1.0 mg	1	238

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/NCT01429987

GET https://conductscience.org/api/trials/v1/NCT01429987/events?page=2

API reference For AI assistants