Study · 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 BD, Sharma A, Walker A, Laitman AP, Chang L

Neurogastroenterology and motility18 Jun 2023Cited by 7 (Europe PMC)

PMID37332239DOI10.1111/nmo.14632PepBankPUB-37332239

Publisher page PubMedAsk about this study

Summary

BackgroundPatients with chronic idiopathic constipation (CIC) and irritable bowel syndrome with constipation (IBS-C) often experience severe symptoms. The current aim was to evaluate plecanatide in adults with CIC or IBS-C with severe constipation.MethodsData were analyzed post hoc from randomized, placebo-controlled trials (CIC [n = 2], IBS-C [n = 2]) of plecanatide 3 mg, 6 mg, or placebo administered for 12 weeks. Severe constipation was defined as no complete spontaneous bowel movements (CSBMs) and an average straining score ≥3.0 (CIC; 5-point scale) or ≥8.0 (IBS-C; 11-point scale) during a 2-week screening. Primary efficacy endpoints were durable overall CSBM responders (CIC: ≥3 CSBMs/week, plus increase from baseline of ≥1 CSBM/week, for ≥9 of 12 weeks, including ≥3 of the last 4 weeks) and overall responders (IBS-C: ≥30% reduction from baseline in abdominal pain and ≥1 CSBM/week increase for ≥6 of 12 weeks).Key resultsSevere constipation was observed in 24.5% (646/2639) and 24.2% (527/2176) of CIC and IBS-C populations, respectively. The CIC durable overall CSBM response rate (plecanatide 3 mg, 20.9%; plecanatide 6 mg, 20.2%; placebo, 11.3%) and IBS-C overall response rate (plecanatide 3 mg, 33.0%; plecanatide 6 mg, 31.0%; placebo, 19.0%) were significantly greater with plecanatide versus placebo (p ≤ 0.01 for all). Median time to first CSBM in CIC and IBS-C populations were significantly shorter with plecanatide 3 mg versus placebo (p = 0.01 for both).Conclusions and inferencesPlecanatide was effective in the treatment of severe constipation in adults with CIC or IBS-C.

CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with severe CIC, durable CSBM response was 20.9% with plecanatide 3 mg versus 11.3% with placebo (p ≤ 0.01).
In plain wordsIn severe CIC, bowel response was 20.9% with plecanatide 3 mg versus 11.3% with placebo.
Peptide
Plecanatide
Outcome
IncreaseDurable overall CSBM response in severe CIC
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
3 mg · 12 weeksAs given in this study (human).
Measurements
Durable overall CSBM response rate
20.9%
plecanatide 3 mg, severe CIC
Durable overall CSBM response rate
11.3%
placebo, severe CIC
Source sentences
Summary
The CIC durable overall CSBM response rate (plecanatide 3 mg, 20.9%; plecanatide 6 mg, 20.2%; placebo, 11.3%) and IBS-C overall response rate (plecanatide 3 mg, 33.0%; plecanatide 6 mg, 31.0%; placebo, 19.0%) were significantly greater with plecanatide versus placebo (p ≤ 0.01 for all).
2 context sentences(design, population, supporting numbers)
Summary · context
Data were analyzed post hoc from randomized, placebo-controlled trials (CIC [n = 2], IBS-C [n = 2]) of plecanatide 3 mg, 6 mg, or placebo administered for 12 weeks.
Summary · context
Severe constipation was defined as no complete spontaneous bowel movements (CSBMs) and an average straining score ≥3.0 (CIC; 5-point scale) or ≥8.0 (IBS-C; 11-point scale) during a 2-week screening.
Show in the study text Report a problemFND-3733223901
02HumanRandomized controlled trialEfficacy outcome
In adults with severe CIC, durable CSBM response was 20.2% with plecanatide 6 mg versus 11.3% with placebo (p ≤ 0.01).
In plain wordsIn severe CIC, bowel response was 20.2% with plecanatide 6 mg versus 11.3% with placebo.
Peptide
Plecanatide
Outcome
IncreaseDurable overall CSBM response in severe CIC
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
6 mg · 12 weeksAs given in this study (human).
Measurements
Durable overall CSBM response rate
20.2%
plecanatide 6 mg, severe CIC
Durable overall CSBM response rate
11.3%
placebo, severe CIC
Source sentences
Summary
The CIC durable overall CSBM response rate (plecanatide 3 mg, 20.9%; plecanatide 6 mg, 20.2%; placebo, 11.3%) and IBS-C overall response rate (plecanatide 3 mg, 33.0%; plecanatide 6 mg, 31.0%; placebo, 19.0%) were significantly greater with plecanatide versus placebo (p ≤ 0.01 for all).
2 context sentences(design, population, supporting numbers)
Summary · context
Data were analyzed post hoc from randomized, placebo-controlled trials (CIC [n = 2], IBS-C [n = 2]) of plecanatide 3 mg, 6 mg, or placebo administered for 12 weeks.
Summary · context
Severe constipation was defined as no complete spontaneous bowel movements (CSBMs) and an average straining score ≥3.0 (CIC; 5-point scale) or ≥8.0 (IBS-C; 11-point scale) during a 2-week screening.
Show in the study text Report a problemFND-3733223902
03HumanRandomized controlled trialEfficacy outcome
In adults with severe IBS-C, overall response was 33.0% with plecanatide 3 mg versus 19.0% with placebo (p ≤ 0.01).
In plain wordsIn severe IBS-C, overall response was 33.0% with plecanatide 3 mg versus 19.0% with placebo.
Peptide
Plecanatide
Outcome
IncreaseOverall response in severe IBS-C
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
3 mg · 12 weeksAs given in this study (human).
Measurements
Overall response rate
33%
plecanatide 3 mg, severe IBS-C
Overall response rate
19%
placebo, severe IBS-C
Source sentences
Summary
The CIC durable overall CSBM response rate (plecanatide 3 mg, 20.9%; plecanatide 6 mg, 20.2%; placebo, 11.3%) and IBS-C overall response rate (plecanatide 3 mg, 33.0%; plecanatide 6 mg, 31.0%; placebo, 19.0%) were significantly greater with plecanatide versus placebo (p ≤ 0.01 for all).
2 context sentences(design, population, supporting numbers)
Summary · context
Data were analyzed post hoc from randomized, placebo-controlled trials (CIC [n = 2], IBS-C [n = 2]) of plecanatide 3 mg, 6 mg, or placebo administered for 12 weeks.
Summary · context
Severe constipation was defined as no complete spontaneous bowel movements (CSBMs) and an average straining score ≥3.0 (CIC; 5-point scale) or ≥8.0 (IBS-C; 11-point scale) during a 2-week screening.
Show in the study text Report a problemFND-3733223903
04HumanRandomized controlled trialEfficacy outcome
In adults with severe IBS-C, overall response was 31.0% with plecanatide 6 mg versus 19.0% with placebo (p ≤ 0.01).
In plain wordsIn severe IBS-C, overall response was 31.0% with plecanatide 6 mg versus 19.0% with placebo.
Peptide
Plecanatide
Outcome
IncreaseOverall response in severe IBS-C
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
6 mg · 12 weeksAs given in this study (human).
Measurements
Overall response rate
31%
plecanatide 6 mg, severe IBS-C
Overall response rate
19%
placebo, severe IBS-C
Source sentences
Summary
The CIC durable overall CSBM response rate (plecanatide 3 mg, 20.9%; plecanatide 6 mg, 20.2%; placebo, 11.3%) and IBS-C overall response rate (plecanatide 3 mg, 33.0%; plecanatide 6 mg, 31.0%; placebo, 19.0%) were significantly greater with plecanatide versus placebo (p ≤ 0.01 for all).
2 context sentences(design, population, supporting numbers)
Summary · context
Data were analyzed post hoc from randomized, placebo-controlled trials (CIC [n = 2], IBS-C [n = 2]) of plecanatide 3 mg, 6 mg, or placebo administered for 12 weeks.
Summary · context
Severe constipation was defined as no complete spontaneous bowel movements (CSBMs) and an average straining score ≥3.0 (CIC; 5-point scale) or ≥8.0 (IBS-C; 11-point scale) during a 2-week screening.
Show in the study text Report a problemFND-3733223904
05HumanRandomized controlled trialEfficacy outcome
In adults with severe CIC, plecanatide 3 mg shortened median time to first CSBM versus placebo (p = 0.01).
In plain wordsIn severe CIC, plecanatide 3 mg shortened time to the first complete bowel movement versus placebo.
Peptide
Plecanatide
Outcome
DecreaseTime to first CSBM in severe CIC
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
3 mg · 12 weeksAs given in this study (human).
Source sentences
Summary
Median time to first CSBM in CIC and IBS-C populations were significantly shorter with plecanatide 3 mg versus placebo (p = 0.01 for both).
2 context sentences(design, population, supporting numbers)
Summary · context
Data were analyzed post hoc from randomized, placebo-controlled trials (CIC [n = 2], IBS-C [n = 2]) of plecanatide 3 mg, 6 mg, or placebo administered for 12 weeks.
Summary · context
Severe constipation was defined as no complete spontaneous bowel movements (CSBMs) and an average straining score ≥3.0 (CIC; 5-point scale) or ≥8.0 (IBS-C; 11-point scale) during a 2-week screening.
Show in the study text Report a problemFND-3733223905
06HumanRandomized controlled trialEfficacy outcome
In adults with severe IBS-C, plecanatide 3 mg shortened median time to first CSBM versus placebo (p = 0.01).
In plain wordsIn severe IBS-C, plecanatide 3 mg shortened time to the first complete bowel movement versus placebo.
Peptide
Plecanatide
Outcome
DecreaseTime to first CSBM in severe IBS-C
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
3 mg · 12 weeksAs given in this study (human).
Source sentences
Summary
Median time to first CSBM in CIC and IBS-C populations were significantly shorter with plecanatide 3 mg versus placebo (p = 0.01 for both).
2 context sentences(design, population, supporting numbers)
Summary · context
Data were analyzed post hoc from randomized, placebo-controlled trials (CIC [n = 2], IBS-C [n = 2]) of plecanatide 3 mg, 6 mg, or placebo administered for 12 weeks.
Summary · context
Severe constipation was defined as no complete spontaneous bowel movements (CSBMs) and an average straining score ≥3.0 (CIC; 5-point scale) or ≥8.0 (IBS-C; 11-point scale) during a 2-week screening.
Show in the study text Report a problemFND-3733223906

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials4

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

4 trials · 4 completed · 4 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT02493452

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

Bausch Health Americas, Inc.n = 1,135Jun 2015 to Feb 2017

Irritable Bowel Syndrome Characterized by Constipation

Trial page ClinicalTrials.govUpdated 14 Jun 2019

CompletedPhase 3Results postedNCT02387359

The Plecanatide Irritable Bowel Syndrome With Constipation Safety and Efficacy Study (IBS-C)

Bausch Health Americas, Inc.n = 1,054Dec 2014 to Feb 2017

Irritable Bowel Syndrome Characterized by Constipation

Trial page ClinicalTrials.govUpdated 20 Oct 2026

CompletedPhase 3Results postedNCT02122471

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

Bausch Health Americas, Inc.n = 1,410Apr 2014 to Jul 2015

Chronic Idiopathic Constipation

Trial page ClinicalTrials.govUpdated 28 May 2019

CompletedPhase 3Results postedNCT01982240

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

Bausch Health Americas, Inc.n = 1,394Nov 2013 to Jun 2015

Chronic Idiopathic Constipation

Trial page ClinicalTrials.govUpdated 26 Dec 2019

Version history

PepBank keeps every version of the data on this study. Status changes from Retraction Watch, Europe PMC and Crossref are listed with their source.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
Version 1
27 Oct 2026, 16:37 UTC
First added · source update from Europe PMC

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