Study · Randomized controlled trial · n = 605 · 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 DM, Shin AS, Laitman AP, Deutsch JK, Kunkel DC

Journal of gastroenterology and hepatology10 Nov 2025Cited by 3 (Europe PMC)

PMID41214272PMCIDPMC12666612DOI10.1111/jgh.70119PepBankPUB-41214272

Summary

Background and aimIrritable bowel syndrome with constipation (IBS-C) is characterized by multiple sensory symptoms, including abdominal pain, bloating, and bowel habit alterations. Therapeutic response should address all components. This study assesses a new exploratory trisymptom composite efficacy endpoint in an IBS-C population of young adults with bloating treated with plecanatide.MethodsPooled data were analyzed from two phase 3, randomized, double-blind trials. Patients (18-40 years) with IBS-C and baseline bloating (score ≥ 1) received plecanatide 3 mg or placebo for 12 weeks. The composite response definition was simultaneous improvement from baseline in three symptoms (abdominal pain, bloating, and complete spontaneous bowel movements [CSBMs]/week) for ≥ 6 of 12 weeks using several thresholds (≥ 2-point or ≥ 30% or ≥ 40% improvement in abdominal pain and bloating plus an increase of ≥ 1 or ≥ 2 CSBMs in the same week).ResultsSix hundred and five adults were included (plecanatide [n = 313]; placebo [n = 292]). Plecanatide/placebo baseline mean symptom scores were 6.2/6.4 for abdominal pain and 6.4/6.6 for bloating; both had a mean of 0.2 CSBMs/week. Significantly more patients in plecanatide versus placebo groups (p ≤ 0.01 for all comparisons) were trisymptom composite responders by several stringent thresholds, including ≥ 30% improvement in pain and bloating plus ≥ 1 CSBM/week increase (23.3% vs. 13.4%; p = 0.002) and ≥ 30% improvement in pain and bloating plus ≥ 2 CSBMs/week increase (19.5% vs. 8.9%; p < 0.001). Plecanatide was well tolerated.ConclusionPlecanatide simultaneously and significantly improved combined symptoms of abdominal pain, bloating, and CSBM frequency at varying thresholds. Plecanatide is effective in improving global IBS-C symptoms in individuals with bloating.Trial registrationClinicalTrials.gov identifiers-NCT02387359 and NCT02493452.

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

Results from this study3

3 results from studies that gave the peptide. 3 results from people.

01HumanRandomized controlled trialEfficacy outcome
In young adults with IBS-C and bloating, plecanatide increased composite response with ≥ 30% pain and bloating improvement and ≥ 1 additional CSBM/week: 23.3% versus 13.4% with placebo (p = 0.002).
In plain wordsIn young adults with IBS-C and bloating, plecanatide increased the trisymptom response versus placebo at the lower CSBM threshold.
Peptide
Plecanatide
Outcome
IncreaseTrisymptom response with at least one additional CSBM
Study
n = 605
Comparator
Placebo
Analysis
Exploratory
Outcome group
Bowel Function · Gastrointestinal
Studied dose
3 mg · 12 weeksAs given in this study (human).
Measurements
Trisymptom composite response (>=30% pain and bloating improvement plus >=1 CSBM/week increase)
23.3%
plecanatide 3 mg
Trisymptom composite response (>=30% pain and bloating improvement plus >=1 CSBM/week increase)
13.4%
placebo
P value
0.002 P
plecanatide versus placebo, >=1 CSBM/week threshold
Source sentences
Summary
Significantly more patients in plecanatide versus placebo groups (p ≤ 0.01 for all comparisons) were trisymptom composite responders by several stringent thresholds, including ≥ 30% improvement in pain and bloating plus ≥ 1 CSBM/week increase (23.3% vs. 13.4%; p = 0.002)
2 context sentences(design, population, supporting numbers)
Summary · context
Pooled data were analyzed from two phase 3, randomized, double-blind trials.
Summary · context
Patients (18-40 years) with IBS-C and baseline bloating (score ≥ 1) received plecanatide 3 mg or placebo for 12 weeks.
Show in the study text Report a problemFND-4121427201
02HumanRandomized controlled trialEfficacy outcome
In young adults with IBS-C and bloating, plecanatide increased composite response with ≥ 30% pain and bloating improvement and ≥ 2 additional CSBMs/week: 19.5% versus 8.9% with placebo (p < 0.001).
In plain wordsIn young adults with IBS-C and bloating, plecanatide increased the trisymptom response versus placebo at the higher CSBM threshold.
Peptide
Plecanatide
Outcome
IncreaseTrisymptom response with at least two additional CSBMs
Study
n = 605
Comparator
Placebo
Analysis
Exploratory
Outcome group
Bowel Function · Gastrointestinal
Studied dose
3 mg · 12 weeksAs given in this study (human).
Measurements
Trisymptom composite response (>=30% pain and bloating improvement plus >=2 CSBMs/week increase)
19.5%
plecanatide 3 mg
Trisymptom composite response (>=30% pain and bloating improvement plus >=2 CSBMs/week increase)
8.9%
placebo
P value
< 0.001 P
plecanatide versus placebo, >=2 CSBMs/week threshold
Source sentences
Summary
and ≥ 30% improvement in pain and bloating plus ≥ 2 CSBMs/week increase (19.5% vs. 8.9%; p < 0.001).
3 context sentences(design, population, supporting numbers)
Summary · context
Significantly more patients in plecanatide versus placebo groups (p ≤ 0.01 for all comparisons) were trisymptom composite responders by several stringent thresholds,
Summary · context
Pooled data were analyzed from two phase 3, randomized, double-blind trials.
Summary · context
Patients (18-40 years) with IBS-C and baseline bloating (score ≥ 1) received plecanatide 3 mg or placebo for 12 weeks.
Show in the study text Report a problemFND-4121427202
03HumanNon-randomized trialSafety outcome
In young adults with IBS-C and bloating, plecanatide was well tolerated.
In plain wordsIn young adults with IBS-C and bloating, plecanatide was well tolerated.
Peptide
Plecanatide
Outcome
Not applicableTolerability
Study
n = 313
Outcome group
Adverse events · Whole body
Studied dose
3 mg · 12 weeksAs given in this study (human).
Source sentences
Summary
Plecanatide was well tolerated.
2 context sentences(design, population, supporting numbers)
Summary · context
Pooled data were analyzed from two phase 3, randomized, double-blind trials.
Summary · context
Patients (18-40 years) with IBS-C and baseline bloating (score ≥ 1) received plecanatide 3 mg or placebo for 12 weeks.
Show in the study text Report a problemFND-4121427203

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

Registered trials2

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

2 trials · 2 completed · 2 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

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

Subjects

Terms as the source lists them.

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