Trial · NCT01982240

12-Week Study of Plecanatide for CIC (The CIC3 Study)

NCT01982240, Phase 3, Completed, Bausch Health Americas, Inc.; results first posted 2019-03-21

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. 12-Week Study of Plecanatide for CIC (The CIC3 Study). Trials, record NCT01982240. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01982240

On this page

Trial

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

Title: 12-Week Study of Plecanatide for CIC (The CIC3 Study)
NCT number: NCT01982240
Status: Completed
Phases: Phase 3
Enrollment: 1,394 participants, actual
Lead sponsor: Bausch Health Americas, Inc.
Conditions: Chronic Idiopathic Constipation
Interventions: Plecanatide, Placebo, Bisacodyl
First posted: 2013-11-13
Last updated: 2019-12-26
Results first posted: 2019-03-21

Source ClinicalTrials.gov

Registered outcomes5

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

List	Outcome	Time frame	Description
Primary	Number of Durable Overall CSBM Responders , Mean Replacement Approach	12-week Treatment Period	A durable overall CSBM responder was defined as a weekly CSBM responder for at least 9 of the 12 treatment weeks, included at least 3 of the last 4 weeks. A CSBM weekly responder was defined as a patient who has ≥ 3 Complete Spontaneous Bowel Movements (CSBMs) per week and an increase from baseline of ≥1 CSBM for that week. A CSBM was a bowel movement that occurred in the absence of laxative use within 24 hours and was associated with the feeling of complete evacuation.
Secondary	Change From Baseline in CSBMs (CSBMS/Week) Over 12-week Treatment Period, Mean Replacement Approach	12-Week Treatment Period	A Complete Spontaneous Bowel Movement (CSBM) was a Bowel Movement (BM) that occurred in the absence of laxative use within 24 hours of the BM and the patient reported a feeling of complete evacuation. A weekly responder had 3 or more CSBMs and an increase of at least one CSBM from baseline in the same week.
Secondary	Change From Baseline in SBM (SBMs/Week) Over 12-week Treatment Period, Mean Replacement Approach	12-Week Treatment Period	The change from baseline in the number of Spontaneous Bowel Movement (SBM) over the 12-week Treatment Period was assessed. Baseline was the mean number of SBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly SBM totals were derived from the daily diary entries reported during the Treatment Period in the BM and Symptom Diary.
Secondary	Change From Baseline in Stool Consistency Score Over the 12-week Treatment Period, Mean Replacement Approach	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 Straining Score Over 12-Week Treatment Period, Mean Replacement Approach	12-Week Treatment Period	Baseline was the mean of non-missing straining scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly average straining score was derived from the straining scores reported during the Treatment Period in the Daily Symptom Diary. The severity of straining during bowel movements was assessed on a 5-point Likert scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.

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	Number of Durable Overall CSBM Responders , Mean Replacement Approach	12-week Treatment Period	The ITT (Intent-to-treat) population was used for analysis.	Participants	COUNT_OF_PARTICIPANTS
SECONDARY	Change From Baseline in CSBMs (CSBMS/Week) Over 12-week Treatment Period, Mean Replacement Approach	12-Week Treatment Period	The ITT (Intent-to-treat) population was used for analysis.	CSBMs per week	MEAN
SECONDARY	Change From Baseline in SBM (SBMs/Week) Over 12-week Treatment Period, Mean Replacement Approach	12-Week Treatment Period	The ITT (Intent-to-treat) population was used for analysis.	SBMs per week	MEAN
SECONDARY	Change From Baseline in Stool Consistency Score Over the 12-week Treatment Period, Mean Replacement Approach	12-Week Treatment Period	The ITT (Intent-to-treat) population was used for analysis.	score on a scale	MEAN
SECONDARY	Change From Baseline in Straining Score Over 12-Week Treatment Period, Mean Replacement Approach	12-Week Treatment Period	The ITT (Intent-to-treat) population was used for analysis.	score on a scale	MEAN

Source ClinicalTrials.gov

Results by group27

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

Outcome	Group	Category	Value	Spread	Units
Number of Durable Overall CSBM Responders , Mean Replacement Approach	Placebo		46		Participants
Number of Durable Overall CSBM Responders , Mean Replacement Approach	Plecanatide 3.0 mg		95		Participants
Number of Durable Overall CSBM Responders , Mean Replacement Approach	Plecanatide 6.0 mg		86		Participants
Change From Baseline in CSBMs (CSBMS/Week) Over 12-week Treatment Period, Mean Replacement Approach	Placebo	Baseline	0.39	Standard Deviation 0.570	CSBMs per week
Change From Baseline in CSBMs (CSBMS/Week) Over 12-week Treatment Period, Mean Replacement Approach	Plecanatide 3.0 mg	Baseline	0.32	Standard Deviation 0.514	CSBMs per week
Change From Baseline in CSBMs (CSBMS/Week) Over 12-week Treatment Period, Mean Replacement Approach	Plecanatide 6.0 mg	Baseline	0.32	Standard Deviation 0.509	CSBMs per week
Change From Baseline in CSBMs (CSBMS/Week) Over 12-week Treatment Period, Mean Replacement Approach	Placebo	Week 12 change from baseline	1.45	Standard Deviation 2.310	CSBMs per week
Change From Baseline in CSBMs (CSBMS/Week) Over 12-week Treatment Period, Mean Replacement Approach	Plecanatide 3.0 mg	Week 12 change from baseline	2.68	Standard Deviation 3.891	CSBMs per week
Change From Baseline in CSBMs (CSBMS/Week) Over 12-week Treatment Period, Mean Replacement Approach	Plecanatide 6.0 mg	Week 12 change from baseline	2.39	Standard Deviation 3.296	CSBMs per week
Change From Baseline in SBM (SBMs/Week) Over 12-week Treatment Period, Mean Replacement Approach	Placebo	Baseline	2.18	Standard Deviation 2.032	SBMs per week

1 to 10 of 27Source ClinicalTrials.gov

See all 27 results by group

Participant flow9

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

Period	Milestone	Group	Participants
Overall Study	STARTED	Placebo	452
Overall Study	STARTED	Plecanatide 3.0 mg	453
Overall Study	STARTED	Plecanatide 6 mg	441
Overall Study	COMPLETED	Placebo	385
Overall Study	COMPLETED	Plecanatide 3.0 mg	384
Overall Study	COMPLETED	Plecanatide 6 mg	371
Overall Study	NOT COMPLETED	Placebo	67
Overall Study	NOT COMPLETED	Plecanatide 3.0 mg	69
Overall Study	NOT COMPLETED	Plecanatide 6 mg	70

Source ClinicalTrials.gov

Adverse events48

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	Placebo	6	458	6
other	Diarrhoea	Gastrointestinal disorders	Plecanatide 3.0 mg	28	474	28
other	Diarrhoea	Gastrointestinal disorders	Plecanatide 6.0 mg	26	457	28
other	Sinusitis	Infections and infestations	Placebo	2	458	2
other	Sinusitis	Infections and infestations	Plecanatide 3.0 mg	10	474	11
other	Sinusitis	Infections and infestations	Plecanatide 6.0 mg	0	457	0
other	Nasopharyngitis	Infections and infestations	Placebo	0	458	0
other	Nasopharyngitis	Infections and infestations	Plecanatide 3.0 mg	0	474	0
other	Nasopharyngitis	Infections and infestations	Plecanatide 6.0 mg	11	457	12
serious	Intestinal obstruction	Gastrointestinal disorders	Placebo	0	458	0

1 to 10 of 48Source ClinicalTrials.gov

See all 48 adverse events

Adverse event totals9

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Placebo
Total, all-cause mortality	Plecanatide 3.0 mg
Total, all-cause mortality	Plecanatide 6.0 mg
Total, other adverse events	Placebo	8	458
Total, other adverse events	Plecanatide 3.0 mg	38	474
Total, other adverse events	Plecanatide 6.0 mg	37	457
Total, serious adverse events	Placebo	4	458
Total, serious adverse events	Plecanatide 3.0 mg	6	474
Total, serious adverse events	Plecanatide 6.0 mg	5	457

Source ClinicalTrials.gov

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as	Source
28169285	DERIVED	PubMed
32660770	DERIVED	PubMed
35086735	DERIVED	PubMed
37162147	DERIVED	PubMed
37332239	DERIVED	PubMed

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/NCT01982240

GET https://conductscience.org/api/trials/v1/NCT01982240/results?page=2

API reference For AI assistants