Study · Randomized controlled trial · n = 4,364 · 2020

14 results

Evaluation of Plecanatide for the Treatment of Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation in Patients 65 Years or Older.

Menees SB, Franklin H, Chey WD

Clinical therapeutics10 Jul 2020Cited by 8 (Europe PMC)

PMID32660770DOI10.1016/j.clinthera.2020.05.012PepBankPUB-32660770

Publisher page 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-ND. Results still quote short attributed sentences.

Results from this study14

14 results from studies that gave the peptide. 14 results from people.

01HumanRandomized controlled trialEfficacy outcome
In patients aged <65 years with CIC or IBS-C, plecanatide improved stool consistency at week 12 versus placebo.
In plain wordsIn younger patients with CIC or IBS-C, plecanatide improved stool consistency at week 12 versus placebo.
Peptide
Plecanatide
Outcome
Direction not reportedStool consistency at week 12 in younger adults
Study
n = 4,364
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
Dose not stated
Source sentences
Summary
Compared with placebo, plecanatide produced statistically significant improvements in stool consistency from baseline at week 12 (both age groups),
3 context sentences(design, population, supporting numbers)
Summary · context
This analysis pooled data from Phase III trials in CIC and IBS-C to assess the safety and efficacy of plecanatide in patients aged ≥65 years.
Summary · context
Patients randomized to receive plecanatide (3 or 6 mg) or placebo from two CIC and two IBS-C trials were pooled.
Summary · context
Efficacy and safety profile results are reported per age group (≥65 and <65 years of age).
Report a problemFND-3266077002
02HumanRandomized controlled trialEfficacy outcome
In patients aged <65 years, plecanatide improved time to first CSBM versus placebo.
In plain wordsIn younger patients, plecanatide improved the time to the first complete bowel movement compared with placebo.
Peptide
Plecanatide
Outcome
Direction not reportedTime to first CSBM in younger adults
Study
n = 4,364
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
Dose not stated
Source sentences
Summary
and time from start of therapy to first CSBM (both age groups) and SBM (plecanatide 6 mg group aged ≥65 years and both plecanatide groups aged <65 years).
4 context sentences(design, population, supporting numbers)
Summary · context
Compared with placebo, plecanatide produced statistically significant improvements in
Summary · context
This analysis pooled data from Phase III trials in CIC and IBS-C to assess the safety and efficacy of plecanatide in patients aged ≥65 years.
Summary · context
Patients randomized to receive plecanatide (3 or 6 mg) or placebo from two CIC and two IBS-C trials were pooled.
Summary · context
Efficacy and safety profile results are reported per age group (≥65 and <65 years of age).
Report a problemFND-3266077010
03HumanRandomized controlled trialEfficacy outcome
In patients aged ≥65 years with CIC or IBS-C, plecanatide improved stool consistency at week 12 versus placebo.
In plain wordsIn older patients with CIC or IBS-C, plecanatide improved stool consistency at week 12 versus placebo.
Peptide
Plecanatide
Outcome
Direction not reportedStool consistency at week 12 in older adults
Study
n = 451
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
Dose not stated
Source sentences
Summary
Compared with placebo, plecanatide produced statistically significant improvements in stool consistency from baseline at week 12 (both age groups),
3 context sentences(design, population, supporting numbers)
Summary · context
This analysis pooled data from Phase III trials in CIC and IBS-C to assess the safety and efficacy of plecanatide in patients aged ≥65 years.
Summary · context
Patients randomized to receive plecanatide (3 or 6 mg) or placebo from two CIC and two IBS-C trials were pooled.
Summary · context
Efficacy and safety profile results are reported per age group (≥65 and <65 years of age).
Report a problemFND-3266077001
04HumanRandomized controlled trialEfficacy outcome
In patients aged ≥65 years, plecanatide improved time to first CSBM versus placebo.
In plain wordsIn older patients, plecanatide improved the time to the first complete bowel movement compared with placebo.
Peptide
Plecanatide
Outcome
Direction not reportedTime to first CSBM in older adults
Study
n = 451
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
Dose not stated
Source sentences
Summary
and time from start of therapy to first CSBM (both age groups) and SBM (plecanatide 6 mg group aged ≥65 years and both plecanatide groups aged <65 years).
4 context sentences(design, population, supporting numbers)
Summary · context
Compared with placebo, plecanatide produced statistically significant improvements in
Summary · context
This analysis pooled data from Phase III trials in CIC and IBS-C to assess the safety and efficacy of plecanatide in patients aged ≥65 years.
Summary · context
Patients randomized to receive plecanatide (3 or 6 mg) or placebo from two CIC and two IBS-C trials were pooled.
Summary · context
Efficacy and safety profile results are reported per age group (≥65 and <65 years of age).
Report a problemFND-3266077009
05HumanRandomized controlled trialEfficacy outcome
In patients aged ≥65 years, plecanatide 3 mg improved CSBM frequency from baseline at week 12 versus placebo.
In plain wordsIn older patients, plecanatide 3 mg improved complete bowel movement frequency from baseline at week 12 compared with placebo.
Peptide
Plecanatide
Outcome
Direction not reportedCSBM frequency at week 12 in older adults
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
3 mgAs given in this study (human).
Source sentences
Summary
Compared with placebo, plecanatide produced statistically significant improvements in stool consistency from baseline at week 12 (both age groups), CSBM and SBM frequency from baseline at week 12 (plecanatide 3 mg group aged ≥65 years and both plecanatide groups aged <65 years),
3 context sentences(design, population, supporting numbers)
Summary · context
This analysis pooled data from Phase III trials in CIC and IBS-C to assess the safety and efficacy of plecanatide in patients aged ≥65 years.
Summary · context
Patients randomized to receive plecanatide (3 or 6 mg) or placebo from two CIC and two IBS-C trials were pooled.
Summary · context
Efficacy and safety profile results are reported per age group (≥65 and <65 years of age).
Report a problemFND-3266077003
06HumanRandomized controlled trialEfficacy outcome
In patients aged ≥65 years, plecanatide 3 mg improved SBM frequency from baseline at week 12 versus placebo.
In plain wordsIn older patients, plecanatide 3 mg improved bowel movement frequency from baseline at week 12 compared with placebo.
Peptide
Plecanatide
Outcome
Direction not reportedSBM frequency at week 12 in older adults
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
3 mgAs given in this study (human).
Source sentences
Summary
Compared with placebo, plecanatide produced statistically significant improvements in stool consistency from baseline at week 12 (both age groups), CSBM and SBM frequency from baseline at week 12 (plecanatide 3 mg group aged ≥65 years and both plecanatide groups aged <65 years),
3 context sentences(design, population, supporting numbers)
Summary · context
This analysis pooled data from Phase III trials in CIC and IBS-C to assess the safety and efficacy of plecanatide in patients aged ≥65 years.
Summary · context
Patients randomized to receive plecanatide (3 or 6 mg) or placebo from two CIC and two IBS-C trials were pooled.
Summary · context
Efficacy and safety profile results are reported per age group (≥65 and <65 years of age).
Report a problemFND-3266077004
07HumanRandomized controlled trialEfficacy outcome
In patients aged <65 years, plecanatide 3 mg improved CSBM frequency from baseline at week 12 versus placebo.
In plain wordsIn younger patients, plecanatide 3 mg improved complete bowel movement frequency from baseline at week 12 compared with placebo.
Peptide
Plecanatide
Outcome
Direction not reportedCSBM frequency at week 12 in younger adults
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
3 mgAs given in this study (human).
Source sentences
Summary
Compared with placebo, plecanatide produced statistically significant improvements in stool consistency from baseline at week 12 (both age groups), CSBM and SBM frequency from baseline at week 12 (plecanatide 3 mg group aged ≥65 years and both plecanatide groups aged <65 years),
3 context sentences(design, population, supporting numbers)
Summary · context
This analysis pooled data from Phase III trials in CIC and IBS-C to assess the safety and efficacy of plecanatide in patients aged ≥65 years.
Summary · context
Patients randomized to receive plecanatide (3 or 6 mg) or placebo from two CIC and two IBS-C trials were pooled.
Summary · context
Efficacy and safety profile results are reported per age group (≥65 and <65 years of age).
Report a problemFND-3266077005
08HumanRandomized controlled trialEfficacy outcome
In patients aged <65 years, plecanatide 6 mg improved CSBM frequency from baseline at week 12 versus placebo.
In plain wordsIn younger patients, plecanatide 6 mg improved complete bowel movement frequency from baseline at week 12 compared with placebo.
Peptide
Plecanatide
Outcome
Direction not reportedCSBM frequency at week 12 in younger adults
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
6 mgAs given in this study (human).
Source sentences
Summary
Compared with placebo, plecanatide produced statistically significant improvements in stool consistency from baseline at week 12 (both age groups), CSBM and SBM frequency from baseline at week 12 (plecanatide 3 mg group aged ≥65 years and both plecanatide groups aged <65 years),
3 context sentences(design, population, supporting numbers)
Summary · context
This analysis pooled data from Phase III trials in CIC and IBS-C to assess the safety and efficacy of plecanatide in patients aged ≥65 years.
Summary · context
Patients randomized to receive plecanatide (3 or 6 mg) or placebo from two CIC and two IBS-C trials were pooled.
Summary · context
Efficacy and safety profile results are reported per age group (≥65 and <65 years of age).
Report a problemFND-3266077006
09HumanRandomized controlled trialEfficacy outcome
In patients aged <65 years, plecanatide 3 mg improved SBM frequency from baseline at week 12 versus placebo.
In plain wordsIn younger patients, plecanatide 3 mg improved bowel movement frequency from baseline at week 12 compared with placebo.
Peptide
Plecanatide
Outcome
Direction not reportedSBM frequency at week 12 in younger adults
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
3 mgAs given in this study (human).
Source sentences
Summary
Compared with placebo, plecanatide produced statistically significant improvements in stool consistency from baseline at week 12 (both age groups), CSBM and SBM frequency from baseline at week 12 (plecanatide 3 mg group aged ≥65 years and both plecanatide groups aged <65 years),
3 context sentences(design, population, supporting numbers)
Summary · context
This analysis pooled data from Phase III trials in CIC and IBS-C to assess the safety and efficacy of plecanatide in patients aged ≥65 years.
Summary · context
Patients randomized to receive plecanatide (3 or 6 mg) or placebo from two CIC and two IBS-C trials were pooled.
Summary · context
Efficacy and safety profile results are reported per age group (≥65 and <65 years of age).
Report a problemFND-3266077007
10HumanRandomized controlled trialEfficacy outcome
In patients aged <65 years, plecanatide 6 mg improved SBM frequency from baseline at week 12 versus placebo.
In plain wordsIn younger patients, plecanatide 6 mg improved bowel movement frequency from baseline at week 12 compared with placebo.
Peptide
Plecanatide
Outcome
Direction not reportedSBM frequency at week 12 in younger adults
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
6 mgAs given in this study (human).
Source sentences
Summary
Compared with placebo, plecanatide produced statistically significant improvements in stool consistency from baseline at week 12 (both age groups), CSBM and SBM frequency from baseline at week 12 (plecanatide 3 mg group aged ≥65 years and both plecanatide groups aged <65 years),
3 context sentences(design, population, supporting numbers)
Summary · context
This analysis pooled data from Phase III trials in CIC and IBS-C to assess the safety and efficacy of plecanatide in patients aged ≥65 years.
Summary · context
Patients randomized to receive plecanatide (3 or 6 mg) or placebo from two CIC and two IBS-C trials were pooled.
Summary · context
Efficacy and safety profile results are reported per age group (≥65 and <65 years of age).
Report a problemFND-3266077008
11HumanRandomized controlled trialEfficacy outcome
In patients aged ≥65 years, plecanatide 6 mg improved time to first SBM versus placebo.
In plain wordsIn older patients, plecanatide 6 mg improved the time to the first bowel movement compared with placebo.
Peptide
Plecanatide
Outcome
Direction not reportedTime to first SBM in older adults
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
6 mgAs given in this study (human).
Source sentences
Summary
and time from start of therapy to first CSBM (both age groups) and SBM (plecanatide 6 mg group aged ≥65 years and both plecanatide groups aged <65 years).
4 context sentences(design, population, supporting numbers)
Summary · context
Compared with placebo, plecanatide produced statistically significant improvements in
Summary · context
This analysis pooled data from Phase III trials in CIC and IBS-C to assess the safety and efficacy of plecanatide in patients aged ≥65 years.
Summary · context
Patients randomized to receive plecanatide (3 or 6 mg) or placebo from two CIC and two IBS-C trials were pooled.
Summary · context
Efficacy and safety profile results are reported per age group (≥65 and <65 years of age).
Report a problemFND-3266077011
12HumanRandomized controlled trialEfficacy outcome
In patients aged <65 years, plecanatide 3 mg improved time to first SBM versus placebo.
In plain wordsIn younger patients, plecanatide 3 mg improved the time to the first bowel movement compared with placebo.
Peptide
Plecanatide
Outcome
Direction not reportedTime to first SBM in younger adults
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
3 mgAs given in this study (human).
Source sentences
Summary
and time from start of therapy to first CSBM (both age groups) and SBM (plecanatide 6 mg group aged ≥65 years and both plecanatide groups aged <65 years).
4 context sentences(design, population, supporting numbers)
Summary · context
Compared with placebo, plecanatide produced statistically significant improvements in
Summary · context
This analysis pooled data from Phase III trials in CIC and IBS-C to assess the safety and efficacy of plecanatide in patients aged ≥65 years.
Summary · context
Patients randomized to receive plecanatide (3 or 6 mg) or placebo from two CIC and two IBS-C trials were pooled.
Summary · context
Efficacy and safety profile results are reported per age group (≥65 and <65 years of age).
Report a problemFND-3266077012
13HumanRandomized controlled trialEfficacy outcome
In patients aged <65 years, plecanatide 6 mg improved time to first SBM versus placebo.
In plain wordsIn younger patients, plecanatide 6 mg improved the time to the first bowel movement compared with placebo.
Peptide
Plecanatide
Outcome
Direction not reportedTime to first SBM in younger adults
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
6 mgAs given in this study (human).
Source sentences
Summary
and time from start of therapy to first CSBM (both age groups) and SBM (plecanatide 6 mg group aged ≥65 years and both plecanatide groups aged <65 years).
4 context sentences(design, population, supporting numbers)
Summary · context
Compared with placebo, plecanatide produced statistically significant improvements in
Summary · context
This analysis pooled data from Phase III trials in CIC and IBS-C to assess the safety and efficacy of plecanatide in patients aged ≥65 years.
Summary · context
Patients randomized to receive plecanatide (3 or 6 mg) or placebo from two CIC and two IBS-C trials were pooled.
Summary · context
Efficacy and safety profile results are reported per age group (≥65 and <65 years of age).
Report a problemFND-3266077013
14HumanNon-randomized trialSafety outcome
No new safety issues were observed with plecanatide in the pooled CIC and IBS-C analysis.
In plain wordsThe pooled CIC and IBS-C analysis found no new safety issues with plecanatide.
Peptide
Plecanatide
Outcome
Direction not reportedNew safety issues
Study
n: not reported in source
Outcome group
Adverse events · Gastrointestinal
Studied dose
3 or 6 mgAs given in this study (human).
Source sentences
Summary
No new safety issues were observed.
3 context sentences(design, population, supporting numbers)
Summary · context
This analysis pooled data from Phase III trials in CIC and IBS-C to assess the safety and efficacy of plecanatide in patients aged ≥65 years.
Summary · context
Patients randomized to receive plecanatide (3 or 6 mg) or placebo from two CIC and two IBS-C trials were pooled.
Summary · context
Efficacy and safety profile results are reported per age group (≥65 and <65 years of age).
Report a problemFND-3266077014

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

Subjects

Terms as the source lists them.

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