Trial · Interventional

CompletedPhase 3Results postedRegistry data

Second Plecanatide Study In Irritable Bowel Syndrome With Constipation (IBS-C)

Short name IBS-C

NCTNCT02493452Other idSP304203-05

Open at ClinicalTrials.govAsk about this trial

Overview

Status: Completed
Phase: Phase 3
Enrollment: 1,135 participants (actual)
Sponsor: Bausch Health Americas, Inc. · Industry
Design: Randomized · Triple masking
Countries: 1 country
United States
Start: Jun 2015
Primary completion: Nov 2016
Completion: Feb 2017
First posted: 9 Jul 2015 (estimated)
Last update posted: 14 Jun 2019
Conditions: Irritable Bowel Syndrome Characterized by Constipation

Timeline

1 trial · 1 completed · 1 with posted results

Completed
Ongoing
Not yet recruiting
Stopped
Estimated dates (est.)
Results posted

2015201620172018

Ph 3
IBS-C
NCT02493452
Jun 2015 to Feb 2017

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

This study in patients with IBS-C is a randomized, double-blind, placebo-controlled, parallel-group clinical trial with 12 weeks of study drug therapy.

Interventions

PlecanatideDrug
PlaceboDrug

Arms3

Active comparator
3.0 mg plecanatide
Plecanatide 3.0 mg dosed daily for 12 weeks
Active comparator
6.0 mg plecanatide
Plecanatide 6.0 mg dosed daily for 12 weeks
Active comparator
Matching placebo
Placebo dosed daily for 12 weeks

Primary outcomes3

Outcomes the sponsor listed as primary.

Number of Overall Responders - ITT Population
Time frame · 12 weeks
Registry description
An Overall Responder was a patient who was a weekly responder (i.e., decrease of 30% from baseline for abdominal pain intensity and an increase of at least 1 complete spontaneous bowel movement in the same week) for at least 6 of the 12 treatment weeks.
Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks
Time frame · 12 Weeks
Registry description
An Abdominal Pain Intensity Responder was a patient who had a decrease of 30 % from baseline for abdominal pain intensity. Baseline is the mean of non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.
Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks
Time frame · 12 Weeks
Registry description
A Stool Frequency Responder was a patient who experienced an increase of at least one CSBM (complete spontaneous bowel movement) per week from baseline. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.

Secondary outcomes(6)

Number of Sustained Efficacy Responders
Time frame · 12 Weeks
Registry description
A Sustained Efficacy Responder was a patient who was an Overall Responder who also was a Weekly Responder, i.e., decreased of 30% from baseline for abdominal pain intensity and increased of at least one CSBM (complete spontaneous bowel movement) in the same week for at least 2 of the 4 weeks in month 3 of the Treatment Period.
Change From Baseline in Stool Consistency
Time frame · Baseline and 12-Week
Registry description
Change from baseline in stool consistency based upon the Bristol Stool Form Scale (BSFS). Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. BSFS Rating 1 to 7: 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
Change From Baseline in Straining
Time frame · Baseline and 12-Week
Registry description
Change from baseline in Straining Score over the 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 severity of straining during a bowel movement was measured using an 11-point scale (0-10 rating; 0 = no straining; 10 = worst straining).
Change From Baseline in CSBMs (CSBMs/Week)Complete Spontaneous Bowel Movement
Time frame · Baseline and 12-Week
Registry description
Change from baseline over the 12-week Treatment Period in CSBM (Complete Spontaneous Bowel Movement) Frequency Rate (CSBMs/Week). Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug.
Number of Patients With a SBM Within 24 Hours After First Dose of Study Medication
Time frame · Up to 24 hours after the first dose of study drug
Registry description
A responder was any patient with a SBM within 24 hours after the first dose of study drug.
Change From Baseline in Abdominal Pain
Time frame · Baseline and 12-Week
Registry description
Change from baseline in abdominal pain as measured with an 11-point (0-10) Numerical Rating Scale from 0 (None) to 10 (Worst Possible). Baseline was the mean of the non-missing abdominal pain scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The average daily abdominal pain score was the average of the non-missing worst daily abdominal pain scores (on a 0 to 10 scale) in the given week.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· 12 weeks

Number of Overall Responders - ITT Population

Group	Value (Participants)
Matching Placebo	54
3.0 mg Plecanatide	81
6.0 mg Plecanatide	91

Primary outcomeCount of participants· 12 Weeks

Number of Abdominal Pain Responders for at Least 6 of 12 Treatment Weeks

Group	Value (Participants)
Matching Placebo	88
3.0 mg Plecanatide	123
6.0 mg Plecanatide	129

Primary outcomeCount of participants· 12 Weeks

Number of Stool Frequency Responder for at Least 6 of the 12 Treatment Weeks

Group	Value (Participants)
Matching Placebo	106
3.0 mg Plecanatide	129
6.0 mg Plecanatide	148

Secondary and other outcome results(5)

Secondary outcomeCount of participants· 12 Weeks

Number of Sustained Efficacy Responders

Group	Value (Participants)
Matching Placebo	53
3.0 mg Plecanatide	78
6.0 mg Plecanatide	90

Secondary outcomeMean· Baseline and 12-Week

Change From Baseline in Stool Consistency

Group	Value (score on a scale)	Spread
Matching Placebo	1.99	1.029
3.0 mg Plecanatide	1.91	0.902
6.0 mg Plecanatide	1.86	0.912

Secondary outcomeMean· Baseline and 12-Week

Change From Baseline in Straining

Group	Value (score on a scale)	Spread
Matching Placebo	6.75	1.848
3.0 mg Plecanatide	6.84	1.860
6.0 mg Plecanatide	6.87	1.920

Secondary outcomeMean· Baseline and 12-Week

Change From Baseline in CSBMs (CSBMs/Week)Complete Spontaneous Bowel Movement

Group	Value (CSBMs per week)	Spread
Matching Placebo	0.24	0.465
3.0 mg Plecanatide	0.26	0.530
6.0 mg Plecanatide	0.27	0.527

Secondary outcomeCount of participants· Up to 24 hours after the first dose of study drug

Number of Patients With a SBM Within 24 Hours After First Dose of Study Medication

Group	Value (Participants)
Matching Placebo	119
3.0 mg Plecanatide	157
6.0 mg Plecanatide	167

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
Group	Deaths	Serious events	Other events
Matching PlaceboPlacebo Tablets dosed once daily for 12 weeks	–	1 / 376	13 / 376
3.0 mg PlecanatidePlecanatide 3.0 mg Tablets dosed once daily for 12 weeks	–	2 / 375	21 / 375
6.0 mg PlecanatidePlecanatide 6.0 mg Tablets dosed once daily for 12 weeks	–	3 / 379	22 / 379

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies3

Studies that cite this trial.

Studies with results

3 studies on this page

Indexing hint: Randomized controlled trial · 2025

3 results

The Effectiveness of Plecanatide for Treating Constipation and Bloating in Patients Aged 18 to 40 Years With Irritable Bowel Syndrome: Utilization of a New Composite Trisymptom Endpoint.

Brenner et al. 2025Journal of gastroenterology and hepatologycited by 3

PMID 41214272PMC12666612DOI 10.1111/jgh.70119PUB-41214272

CC BY3 results

Download PDF See results (3)

Indexing hint: Randomized controlled trial · 2023

6 results

Plecanatide for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation: Post hoc analyses of placebo-controlled trials in adults with severe constipation.

Cash et al. 2023Neurogastroenterology and motilitycited by 7

PMID 37332239DOI 10.1111/nmo.14632PUB-37332239

Full text at the publisher6 results

Publisher page See results (6)

Indexing hint: Randomized controlled trial · 2020

14 results

Evaluation of Plecanatide for the Treatment of Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation in Patients 65 Years or Older.

Menees et al. 2020Clinical therapeuticscited by 8

PMID 32660770DOI 10.1016/j.clinthera.2020.05.012PUB-32660770

Full text at the publisher14 results

Publisher page See results (14)

Eligibility

Who could join, as posted.

Sex: All
Age: from 18 Years up to 85 Years
Healthy volunteers: Not accepted

Inclusion and exclusion criteria, as posted

Inclusion Criteria: • Adult patients between the ages of 18 and 85 years (inclusive) with a diagnosis of IBS based on ROME III diagnostic criteria and meeting criteria for diagnosis of the constipation predominant subtype - IBS-C Exclusion Criteria: * Refusal or inability to sign informed consent for the trial * Refusal or inability to complete daily Episodic (real-time) BM / RM calls, End of Day daily Calls, and/or complete electronic questionnaires * BMI ≥ 40 or \< 18 * Women of child bearing potential who refuse to use an acceptable method of birth control for the duration of the trial * Women who are pregnant or lactating * Diagnosis of IBS-D or IBS-M * Organic or obstructive disease of the small or large intestine * Use of laxatives other than the study-supplied rescue medication (Dulcolax®, bisacodyl) * Use of a prohibited concomitant medication within the time frame prior to screening outlined in the study protocol for that medication * Unstable medical illness * Bilirubin \> 3X ULN in the absence of a conjugation defect * Any laboratory value \> 3X ULN unless discussed and approved by the study Medical Monitor

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