A Randomized Phase III Clinical Trial of Plecanatide, a Uroguanylin Analog, in Patients With Chronic Idiopathic Constipation.

Miner PB Jr, Koltun WD, Wiener GJ, De La Portilla M, Prieto B, Shailubhai K, Layton MB, Barrow L, Magnus L, Griffin PH

The American journal of gastroenterology7 Feb 2017Cited by 108 (Europe PMC)

PMID28169285PMCIDPMC5415706DOI10.1038/ajg.2016.611PepBankPUB-28169285

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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 study10

10 results from studies that gave the peptide. 10 results from people.

01HumanRandomized controlled trialEfficacy outcome
In CIC, durable CSBM response was 21.0% with plecanatide 3 mg versus 10.2% with placebo (P<0.001).
In plain wordsIn CIC, durable bowel response was 21.0% with plecanatide 3 mg versus 10.2% with placebo.
Peptide
Plecanatide
Outcome
IncreaseDurable overall CSBM response
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
3 mg once daily · oral · 12 weeksAs given in this study (human).
Measurements
durable overall CSBM responders
21%
plecanatide 3 mg
durable overall CSBM responders
10.2%
placebo
Source sentences
Summary
Each dose of plecanatide resulted in a significantly greater percentage of durable overall CSBM responders (21.0%, 3 mg; 19.5%, 6 mg) as compared with placebo (10.2%; P<0.001 for both).
2 context sentences(design, population, supporting numbers)
Summary · context
This phase III, multicenter, double-blind, placebo-controlled study randomized 1,394 patients with CIC.
Summary · context
Patients received either plecanatide (3 or 6 mg) or placebo, orally, once daily, for 12 weeks.
Report a problemFND-2816928501
02HumanRandomized controlled trialEfficacy outcome
In CIC, durable CSBM response was 19.5% with plecanatide 6 mg versus 10.2% with placebo (P<0.001).
In plain wordsIn CIC, durable bowel response was 19.5% with plecanatide 6 mg versus 10.2% with placebo.
Peptide
Plecanatide
Outcome
IncreaseDurable overall CSBM response
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
6 mg once daily · oral · 12 weeksAs given in this study (human).
Measurements
durable overall CSBM responders
19.5%
plecanatide 6 mg
durable overall CSBM responders
10.2%
placebo
Source sentences
Summary
Each dose of plecanatide resulted in a significantly greater percentage of durable overall CSBM responders (21.0%, 3 mg; 19.5%, 6 mg) as compared with placebo (10.2%; P<0.001 for both).
2 context sentences(design, population, supporting numbers)
Summary · context
This phase III, multicenter, double-blind, placebo-controlled study randomized 1,394 patients with CIC.
Summary · context
Patients received either plecanatide (3 or 6 mg) or placebo, orally, once daily, for 12 weeks.
Report a problemFND-2816928502
03HumanRandomized controlled trialEfficacy outcome
In CIC, weekly CSBM frequency increased by 2.5/week with plecanatide 3 mg versus 1.2/week with placebo (P<0.001).
In plain wordsIn CIC, complete bowel movements increased by 2.5/week with plecanatide 3 mg versus 1.2/week with placebo.
Peptide
Plecanatide
Outcome
IncreaseWeekly CSBM frequency
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
3 mg once daily · oral · 12 weeksAs given in this study (human).
Measurements
mean weekly CSBM frequency increase from baseline
2.5 CSBMs/week
plecanatide 3 mg
mean weekly CSBM frequency increase from baseline
1.2 CSBMs/week
placebo
Source sentences
Summary
Plecanatide (3 and 6 mg) also significantly increased mean weekly CSBM frequency from baseline (increase of 2.5 and 2.2/week, respectively) vs. placebo (1.2/week; P<0.001 for both) and mean weekly spontaneous bowel movement frequency (increase of 3.2 and 3.1/week, respectively) vs. placebo (1.3/week…
2 context sentences(design, population, supporting numbers)
Summary · context
This phase III, multicenter, double-blind, placebo-controlled study randomized 1,394 patients with CIC.
Summary · context
Patients received either plecanatide (3 or 6 mg) or placebo, orally, once daily, for 12 weeks.
Report a problemFND-2816928503
04HumanRandomized controlled trialEfficacy outcome
In CIC, weekly CSBM frequency increased by 2.2/week with plecanatide 6 mg versus 1.2/week with placebo (P<0.001).
In plain wordsIn CIC, complete bowel movements increased by 2.2/week with plecanatide 6 mg versus 1.2/week with placebo.
Peptide
Plecanatide
Outcome
IncreaseWeekly CSBM frequency
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
6 mg once daily · oral · 12 weeksAs given in this study (human).
Measurements
mean weekly CSBM frequency increase from baseline
2.2 CSBMs/week
plecanatide 6 mg
mean weekly CSBM frequency increase from baseline
1.2 CSBMs/week
placebo
Source sentences
Summary
Plecanatide (3 and 6 mg) also significantly increased mean weekly CSBM frequency from baseline (increase of 2.5 and 2.2/week, respectively) vs. placebo (1.2/week; P<0.001 for both) and mean weekly spontaneous bowel movement frequency (increase of 3.2 and 3.1/week, respectively) vs. placebo (1.3/week…
2 context sentences(design, population, supporting numbers)
Summary · context
This phase III, multicenter, double-blind, placebo-controlled study randomized 1,394 patients with CIC.
Summary · context
Patients received either plecanatide (3 or 6 mg) or placebo, orally, once daily, for 12 weeks.
Report a problemFND-2816928504
05HumanRandomized controlled trialEfficacy outcome
In CIC, weekly SBM frequency increased by 3.2/week with plecanatide 3 mg versus 1.3/week with placebo (P<0.001).
In plain wordsIn CIC, bowel movements increased by 3.2/week with plecanatide 3 mg versus 1.3/week with placebo.
Peptide
Plecanatide
Outcome
IncreaseWeekly SBM frequency
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
3 mg once daily · oral · 12 weeksAs given in this study (human).
Measurements
mean weekly SBM frequency increase from baseline
3.2 SBMs/week
plecanatide 3 mg
mean weekly SBM frequency increase from baseline
1.3 SBMs/week
placebo
Source sentences
Summary
Plecanatide (3 and 6 mg) also significantly increased mean weekly CSBM frequency from baseline (increase of 2.5 and 2.2/week, respectively) vs. placebo (1.2/week; P<0.001 for both) and mean weekly spontaneous bowel movement frequency (increase of 3.2 and 3.1/week, respectively) vs. placebo (1.3/week…
2 context sentences(design, population, supporting numbers)
Summary · context
This phase III, multicenter, double-blind, placebo-controlled study randomized 1,394 patients with CIC.
Summary · context
Patients received either plecanatide (3 or 6 mg) or placebo, orally, once daily, for 12 weeks.
Report a problemFND-2816928505
06HumanRandomized controlled trialEfficacy outcome
In CIC, weekly SBM frequency increased by 3.1/week with plecanatide 6 mg versus 1.3/week with placebo (P<0.001).
In plain wordsIn CIC, bowel movements increased by 3.1/week with plecanatide 6 mg versus 1.3/week with placebo.
Peptide
Plecanatide
Outcome
IncreaseWeekly SBM frequency
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
6 mg once daily · oral · 12 weeksAs given in this study (human).
Measurements
mean weekly SBM frequency increase from baseline
3.1 SBMs/week
plecanatide 6 mg
mean weekly SBM frequency increase from baseline
1.3 SBMs/week
placebo
Source sentences
Summary
Plecanatide (3 and 6 mg) also significantly increased mean weekly CSBM frequency from baseline (increase of 2.5 and 2.2/week, respectively) vs. placebo (1.2/week; P<0.001 for both) and mean weekly spontaneous bowel movement frequency (increase of 3.2 and 3.1/week, respectively) vs. placebo (1.3/week…
2 context sentences(design, population, supporting numbers)
Summary · context
This phase III, multicenter, double-blind, placebo-controlled study randomized 1,394 patients with CIC.
Summary · context
Patients received either plecanatide (3 or 6 mg) or placebo, orally, once daily, for 12 weeks.
Report a problemFND-2816928506
07HumanRandomized controlled trialEfficacy outcome
In CIC, plecanatide 3 mg significantly improved all secondary and additional efficacy endpoints versus placebo.
In plain wordsIn CIC, plecanatide 3 mg improved all secondary and additional efficacy endpoints versus placebo.
Peptide
Plecanatide
Outcome
Direction not reportedSecondary and additional efficacy endpoints
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
3 mg once daily · oral · 12 weeksAs given in this study (human).
Source sentences
Summary
Both plecanatide doses significantly improved all secondary and additional efficacy endpoints.
2 context sentences(design, population, supporting numbers)
Summary · context
This phase III, multicenter, double-blind, placebo-controlled study randomized 1,394 patients with CIC.
Summary · context
Patients received either plecanatide (3 or 6 mg) or placebo, orally, once daily, for 12 weeks.
Report a problemFND-2816928507
08HumanRandomized controlled trialEfficacy outcome
In CIC, plecanatide 6 mg significantly improved all secondary and additional efficacy endpoints versus placebo.
In plain wordsIn CIC, plecanatide 6 mg improved all secondary and additional efficacy endpoints versus placebo.
Peptide
Plecanatide
Outcome
Direction not reportedSecondary and additional efficacy endpoints
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
6 mg once daily · oral · 12 weeksAs given in this study (human).
Source sentences
Summary
Both plecanatide doses significantly improved all secondary and additional efficacy endpoints.
2 context sentences(design, population, supporting numbers)
Summary · context
This phase III, multicenter, double-blind, placebo-controlled study randomized 1,394 patients with CIC.
Summary · context
Patients received either plecanatide (3 or 6 mg) or placebo, orally, once daily, for 12 weeks.
Report a problemFND-2816928508
09HumanRandomized controlled trialSafety outcome
In CIC, diarrhea occurred in 5.9% with plecanatide 3 mg versus 1.3% with placebo.
In plain wordsIn CIC, diarrhea occurred in 5.9% 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 once daily · oral · 12 weeksAs given in this study (human).
Measurements
Diarrhea incidence
5.9%
plecanatide 3 mg
Diarrhea incidence
1.3%
placebo
Source sentences
Summary
The most common AE, diarrhea, occurred in 1.3% (placebo), 5.9% (3 mg) and 5.7% (6 mg) of patients.
2 context sentences(design, population, supporting numbers)
Summary · context
This phase III, multicenter, double-blind, placebo-controlled study randomized 1,394 patients with CIC.
Summary · context
Patients received either plecanatide (3 or 6 mg) or placebo, orally, once daily, for 12 weeks.
Report a problemFND-2816928509
10HumanRandomized controlled trialSafety outcome
In CIC, diarrhea occurred in 5.7% with plecanatide 6 mg versus 1.3% with placebo.
In plain wordsIn CIC, diarrhea occurred in 5.7% 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 once daily · oral · 12 weeksAs given in this study (human).
Measurements
Diarrhea incidence
5.7%
plecanatide 6 mg
Diarrhea incidence
1.3%
placebo
Source sentences
Summary
The most common AE, diarrhea, occurred in 1.3% (placebo), 5.9% (3 mg) and 5.7% (6 mg) of patients.
2 context sentences(design, population, supporting numbers)
Summary · context
This phase III, multicenter, double-blind, placebo-controlled study randomized 1,394 patients with CIC.
Summary · context
Patients received either plecanatide (3 or 6 mg) or placebo, orally, once daily, for 12 weeks.
Report a problemFND-2816928510

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 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

Subjects

Terms as the source lists them.

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