Plecanatide Improves Symptoms of Irritable Bowel Syndrome with Constipation: Results of an Integrated Efficacy and Safety Analysis of Two Phase 3 Trials.

Brenner DM, Dorn SD, Fogel RP, Christie J, Laitman AP, Rosenberg J

International journal of general medicine25 Aug 2023Cited by 4 (Europe PMC)

PMID37649852PMCIDPMC10464888DOI10.2147/ijgm.s400431PepBankPUB-37649852

Read at source PubMedAsk about this study

Summary

The text of this summary is not shown here, because the article license does not allow reuse. Read it at the source (opens in a new tab)

Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with IBS-C, overall response was 25.6% with plecanatide 3 mg versus 16.0% with placebo (P < 0.001).
In plain wordsOverall response was 25.6% with plecanatide 3 mg versus 16.0% with placebo in IBS-C.
Peptide
Plecanatide
Outcome
IncreaseOverall response
Study
n = 1,453
Comparator
Placebo
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
3 mg · 12 weeksAs given in this study (human).
Measurements
Overall response rate
25.6%
plecanatide 3 mg
Overall response rate
16%
placebo
Source sentences
Summary
A significantly greater percentage of patients achieved overall response with plecanatide 3 mg (25.6%) and 6 mg (26.7%) versus placebo (16.0%; both P < 0.001 vs placebo).
1 context sentence(design, population, supporting numbers)
Summary · context
Data pooled from 2 identically designed phase 3 trials included adults with IBS-C randomized to plecanatide 3 mg or 6 mg, or placebo once daily for 12 weeks.
Report a problemFND-3764985201
02HumanRandomized controlled trialEfficacy outcome
In adults with IBS-C, overall response was 26.7% with plecanatide 6 mg versus 16.0% with placebo (P < 0.001).
In plain wordsOverall response was 26.7% with plecanatide 6 mg versus 16.0% with placebo in IBS-C.
Peptide
Plecanatide
Outcome
IncreaseOverall response
Study
n = 1,452
Comparator
Placebo
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
6 mg · 12 weeksAs given in this study (human).
Measurements
Overall response rate
26.7%
plecanatide 6 mg
Overall response rate
16%
placebo
Source sentences
Summary
A significantly greater percentage of patients achieved overall response with plecanatide 3 mg (25.6%) and 6 mg (26.7%) versus placebo (16.0%; both P < 0.001 vs placebo).
1 context sentence(design, population, supporting numbers)
Summary · context
Data pooled from 2 identically designed phase 3 trials included adults with IBS-C randomized to plecanatide 3 mg or 6 mg, or placebo once daily for 12 weeks.
Report a problemFND-3764985202
03HumanRandomized controlled trialEfficacy outcome
In IBS-C, plecanatide improved abdominal discomfort, fullness, bloating, and cramping from Week 1 and pain from Week 2 through Week 12 versus placebo.
In plain wordsIn IBS-C, plecanatide improved five abdominal symptoms versus placebo through Week 12, starting at Week 1 or Week 2.
Peptide
Plecanatide
Outcome
Direction not reportedAbdominal symptoms
Study
n = 2,176
Comparator
Placebo
Analysis
Secondary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
Dose not stated · 12 weeksAs given in this study (human).
Source sentences
Summary
Significant improvements from baseline in abdominal discomfort, abdominal fullness, abdominal pain, bloating, and cramping occurred as early as Week 1 (Week 2 for abdominal pain) with plecanatide and were maintained through Week 12 versus placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
Data pooled from 2 identically designed phase 3 trials included adults with IBS-C randomized to plecanatide 3 mg or 6 mg, or placebo once daily for 12 weeks.
Report a problemFND-3764985205
04HumanRandomized controlled trialEfficacy outcome
In adults with IBS-C, sustained response was 24.3% with plecanatide 3 mg versus 15.6% with placebo (P < 0.001).
In plain wordsSustained response was 24.3% with plecanatide 3 mg versus 15.6% with placebo in IBS-C.
Peptide
Plecanatide
Outcome
IncreaseSustained response
Study
n = 1,453
Comparator
Placebo
Analysis
Secondary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
3 mg · 12 weeksAs given in this study (human).
Measurements
Sustained response rate
24.3%
plecanatide 3 mg
Sustained response rate
15.6%
placebo
Source sentences
Summary
A significantly greater percentage of patients were sustained responders with plecanatide 3 mg (24.3%) and 6 mg (25.6%) versus placebo (15.6%; both P < 0.001 vs placebo).
1 context sentence(design, population, supporting numbers)
Summary · context
Data pooled from 2 identically designed phase 3 trials included adults with IBS-C randomized to plecanatide 3 mg or 6 mg, or placebo once daily for 12 weeks.
Report a problemFND-3764985203
05HumanRandomized controlled trialEfficacy outcome
In adults with IBS-C, sustained response was 25.6% with plecanatide 6 mg versus 15.6% with placebo (P < 0.001).
In plain wordsSustained response was 25.6% with plecanatide 6 mg versus 15.6% with placebo in IBS-C.
Peptide
Plecanatide
Outcome
IncreaseSustained response
Study
n = 1,452
Comparator
Placebo
Analysis
Secondary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
6 mg · 12 weeksAs given in this study (human).
Measurements
Sustained response rate
25.6%
plecanatide 6 mg
Sustained response rate
15.6%
placebo
Source sentences
Summary
A significantly greater percentage of patients were sustained responders with plecanatide 3 mg (24.3%) and 6 mg (25.6%) versus placebo (15.6%; both P < 0.001 vs placebo).
1 context sentence(design, population, supporting numbers)
Summary · context
Data pooled from 2 identically designed phase 3 trials included adults with IBS-C randomized to plecanatide 3 mg or 6 mg, or placebo once daily for 12 weeks.
Report a problemFND-3764985204
06HumanRandomized controlled trialSafety outcome
In IBS-C, diarrhea occurred in 4.3% with plecanatide 3 mg versus 1.0% with placebo.
In plain wordsIn IBS-C, diarrhea occurred in 4.3% with plecanatide 3 mg versus 1.0% with placebo.
Peptide
Plecanatide
Outcome
IncreaseDiarrhea
Study
n: not reported in source
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
3 mg · 12 weeksAs given in this study (human).
Measurements
Diarrhea incidence
4.3%
plecanatide 3 mg
Diarrhea incidence
1%
placebo
Source sentences
Summary
Diarrhea, the most common adverse event, occurred in 4.3% (3 mg), 4.0% (6 mg) and 1.0% (placebo) of patients, leading to study discontinuation in 1.2%, 1.4%, and 0 patients, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Data pooled from 2 identically designed phase 3 trials included adults with IBS-C randomized to plecanatide 3 mg or 6 mg, or placebo once daily for 12 weeks.
Report a problemFND-3764985206
07HumanRandomized controlled trialSafety outcome
In IBS-C, diarrhea occurred in 4.0% with plecanatide 6 mg versus 1.0% with placebo.
In plain wordsIn IBS-C, diarrhea occurred in 4.0% with plecanatide 6 mg versus 1.0% with placebo.
Peptide
Plecanatide
Outcome
IncreaseDiarrhea
Study
n: not reported in source
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
6 mg · 12 weeksAs given in this study (human).
Measurements
Diarrhea incidence
4%
plecanatide 6 mg
Diarrhea incidence
1%
placebo
Source sentences
Summary
Diarrhea, the most common adverse event, occurred in 4.3% (3 mg), 4.0% (6 mg) and 1.0% (placebo) of patients, leading to study discontinuation in 1.2%, 1.4%, and 0 patients, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Data pooled from 2 identically designed phase 3 trials included adults with IBS-C randomized to plecanatide 3 mg or 6 mg, or placebo once daily for 12 weeks.
Report a problemFND-3764985207
08HumanRandomized controlled trialSafety outcome
In IBS-C, diarrhea caused discontinuation in 1.2% with plecanatide 3 mg versus 0 with placebo.
In plain wordsIn IBS-C, diarrhea caused discontinuation in 1.2% with plecanatide 3 mg versus 0 with placebo.
Peptide
Plecanatide
Outcome
IncreaseDiscontinuation due to diarrhea
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Gastrointestinal
Studied dose
3 mg · 12 weeksAs given in this study (human).
Measurements
Discontinuation due to diarrhea
1.2%
plecanatide 3 mg
Discontinuation due to diarrhea
0 patients
placebo
Source sentences
Summary
Diarrhea, the most common adverse event, occurred in 4.3% (3 mg), 4.0% (6 mg) and 1.0% (placebo) of patients, leading to study discontinuation in 1.2%, 1.4%, and 0 patients, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Data pooled from 2 identically designed phase 3 trials included adults with IBS-C randomized to plecanatide 3 mg or 6 mg, or placebo once daily for 12 weeks.
Report a problemFND-3764985208
09HumanRandomized controlled trialSafety outcome
In IBS-C, diarrhea caused discontinuation in 1.4% with plecanatide 6 mg versus 0 with placebo.
In plain wordsIn IBS-C, diarrhea caused discontinuation in 1.4% with plecanatide 6 mg versus 0 with placebo.
Peptide
Plecanatide
Outcome
IncreaseDiscontinuation due to diarrhea
Study
n: not reported in source
Comparator
Placebo
Outcome group
Adverse events · Gastrointestinal
Studied dose
6 mg · 12 weeksAs given in this study (human).
Measurements
Discontinuation due to diarrhea
1.4%
plecanatide 6 mg
Discontinuation due to diarrhea
0 patients
placebo
Source sentences
Summary
Diarrhea, the most common adverse event, occurred in 4.3% (3 mg), 4.0% (6 mg) and 1.0% (placebo) of patients, leading to study discontinuation in 1.2%, 1.4%, and 0 patients, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Data pooled from 2 identically designed phase 3 trials included adults with IBS-C randomized to plecanatide 3 mg or 6 mg, or placebo once daily for 12 weeks.
Report a problemFND-3764985209

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

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.

Publication types

Keywords

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