Randomized clinical trial: efficacy and safety of plecanatide in the treatment of chronic idiopathic constipation.

DeMicco M, Barrow L, Hickey B, Shailubhai K, Griffin P

Therapeutic advances in gastroenterology25 Oct 2017Cited by 63 (Europe PMC)

PMID29147135PMCIDPMC5673020DOI10.1177/1756283x17734697PepBankPUB-29147135

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 CIC, plecanatide 3 mg increased durable overall CSBM response versus placebo (20.1% versus 12.8%, p = 0.004).
In plain wordsIn adults with constipation, plecanatide 3 mg increased durable bowel response versus placebo.
Peptide
Plecanatide
Outcome
IncreaseDurable overall CSBM responders
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 responders
20.1%
plecanatide 3 mg
Durable overall CSBM responders
12.8%
placebo
p value
0.004 p
3 mg versus placebo
Source sentences
Summary
A significantly greater percentage of durable overall CSBM responders resulted with each plecanatide dose compared with placebo (3 mg = 20.1%; 6 mg = 20.0%; placebo = 12.8%; p = 0.004 each dose).
2 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint was the percentage of durable overall CSBM responders (weekly responders for ⩾9 of 12 treatment weeks, including ⩾3 of the last 4 weeks).
Summary · context
Adults meeting modified Rome III CIC criteria were randomized to plecanatide 3 mg (n = 443), 6 mg (n = 449), or placebo (n = 445).
Report a problemFND-2914713501
02HumanRandomized controlled trialEfficacy outcome
In adults with CIC, plecanatide 6 mg increased durable overall CSBM response versus placebo (20.0% versus 12.8%, p = 0.004).
In plain wordsIn adults with constipation, plecanatide 6 mg increased durable bowel response versus placebo.
Peptide
Plecanatide
Outcome
IncreaseDurable overall CSBM responders
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 responders
20%
plecanatide 6 mg
Durable overall CSBM responders
12.8%
placebo
p value
0.004 p
6 mg versus placebo
Source sentences
Summary
A significantly greater percentage of durable overall CSBM responders resulted with each plecanatide dose compared with placebo (3 mg = 20.1%; 6 mg = 20.0%; placebo = 12.8%; p = 0.004 each dose).
2 context sentences(design, population, supporting numbers)
Summary · context
The primary endpoint was the percentage of durable overall CSBM responders (weekly responders for ⩾9 of 12 treatment weeks, including ⩾3 of the last 4 weeks).
Summary · context
Adults meeting modified Rome III CIC criteria were randomized to plecanatide 3 mg (n = 443), 6 mg (n = 449), or placebo (n = 445).
Report a problemFND-2914713502
03HumanRandomized controlled trialSafety outcome
In adults with CIC, diarrhea occurred in 3.2% with plecanatide 3 mg versus 1.3% with placebo.
In plain wordsIn adults with constipation, diarrhea occurred in 3.2% with plecanatide 3 mg versus 1.3% 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
3.2%
plecanatide 3 mg
Diarrhea incidence
1.3%
placebo
Source sentences
Summary
Adverse events were mostly mild/moderate, with diarrhea being the most common (3 mg = 3.2%; 6 mg = 4.5%; placebo = 1.3%).
1 context sentence(design, population, supporting numbers)
Summary · context
Adults meeting modified Rome III CIC criteria were randomized to plecanatide 3 mg (n = 443), 6 mg (n = 449), or placebo (n = 445).
Report a problemFND-2914713508
04HumanRandomized controlled trialSafety outcome
In adults with CIC, diarrhea occurred in 4.5% with plecanatide 6 mg versus 1.3% with placebo.
In plain wordsIn adults with constipation, diarrhea occurred in 4.5% with plecanatide 6 mg versus 1.3% 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
4.5%
plecanatide 6 mg
Diarrhea incidence
1.3%
placebo
Source sentences
Summary
Adverse events were mostly mild/moderate, with diarrhea being the most common (3 mg = 3.2%; 6 mg = 4.5%; placebo = 1.3%).
1 context sentence(design, population, supporting numbers)
Summary · context
Adults meeting modified Rome III CIC criteria were randomized to plecanatide 3 mg (n = 443), 6 mg (n = 449), or placebo (n = 445).
Report a problemFND-2914713509
05HumanNon-randomized trialEfficacy outcome
In adults with CIC, plecanatide significantly improved stool consistency over 12 weeks.
In plain wordsIn adults with constipation, plecanatide improved stool consistency over 12 weeks.
Peptide
Plecanatide
Outcome
Not applicableStool consistency
Study
n: not reported in source
Outcome group
Bowel function · Gastrointestinal
Studied dose
Dose not stated · 12 weeksAs given in this study (human).
Source sentences
Summary
Over the 12 weeks, plecanatide significantly improved stool consistency and stool frequency.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults meeting modified Rome III CIC criteria were randomized to plecanatide 3 mg (n = 443), 6 mg (n = 449), or placebo (n = 445).
Report a problemFND-2914713503
06HumanNon-randomized trialEfficacy outcome
In adults with CIC, plecanatide significantly improved stool frequency over 12 weeks.
In plain wordsIn adults with constipation, plecanatide improved stool frequency over 12 weeks.
Peptide
Plecanatide
Outcome
IncreaseStool frequency
Study
n: not reported in source
Outcome group
Bowel function · Gastrointestinal
Studied dose
Dose not stated · 12 weeksAs given in this study (human).
Source sentences
Summary
Over the 12 weeks, plecanatide significantly improved stool consistency and stool frequency.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults meeting modified Rome III CIC criteria were randomized to plecanatide 3 mg (n = 443), 6 mg (n = 449), or placebo (n = 445).
Report a problemFND-2914713504
07HumanNon-randomized trialEfficacy outcome
In adults with CIC receiving plecanatide, mean weekly SBMs increased significantly from week 1 through week 12.
In plain wordsIn adults receiving plecanatide, weekly spontaneous bowel movements increased from week 1 through week 12.
Peptide
Plecanatide
Outcome
IncreaseWeekly spontaneous bowel movements
Study
n: not reported in source
Outcome group
Bowel function · Gastrointestinal
Studied dose
Dose not stated · 12 weeksAs given in this study (human).
Source sentences
Summary
Significant increases in mean weekly SBMs and CSBMs began in week 1 and were maintained through week 12 in plecanatide-treated patients.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults meeting modified Rome III CIC criteria were randomized to plecanatide 3 mg (n = 443), 6 mg (n = 449), or placebo (n = 445).
Report a problemFND-2914713505
08HumanNon-randomized trialEfficacy outcome
In adults with CIC receiving plecanatide, mean weekly CSBMs increased significantly from week 1 through week 12.
In plain wordsIn adults receiving plecanatide, weekly complete spontaneous bowel movements increased from week 1 through week 12.
Peptide
Plecanatide
Outcome
IncreaseWeekly complete spontaneous bowel movements
Study
n: not reported in source
Outcome group
Bowel function · Gastrointestinal
Studied dose
Dose not stated · 12 weeksAs given in this study (human).
Source sentences
Summary
Significant increases in mean weekly SBMs and CSBMs began in week 1 and were maintained through week 12 in plecanatide-treated patients.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults meeting modified Rome III CIC criteria were randomized to plecanatide 3 mg (n = 443), 6 mg (n = 449), or placebo (n = 445).
Report a problemFND-2914713506
09HumanNon-randomized trialSafety outcome
In a trial of plecanatide versus placebo in adults with CIC, adverse events were mostly mild or moderate; the abstract does not split them by group.
In plain wordsIn adults with constipation in a plecanatide versus placebo trial, adverse events were mostly mild or moderate, not split by group.
Peptide
Plecanatide
Outcome
Not applicableAdverse event severity
Study
n: not reported in source
Outcome group
Adverse events · Whole body
Studied dose
Dose not stated · 12 weeksAs given in this study (human).
Source sentences
Summary
Adverse events were mostly mild/moderate, with diarrhea being the most common (3 mg = 3.2%; 6 mg = 4.5%; placebo = 1.3%).
1 context sentence(design, population, supporting numbers)
Summary · context
Adults meeting modified Rome III CIC criteria were randomized to plecanatide 3 mg (n = 443), 6 mg (n = 449), or placebo (n = 445).
Report a problemFND-2914713507

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

Registered trials1

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

1 trial · 1 completed · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

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

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

PepBank is a research reference. Talk to a doctor before you use any peptide.