Long-term treatment with plecanatide was safe and tolerable in patients with irritable bowel syndrome with constipation.

Barish CF, Crozier RA, Griffin PH

Current medical research and opinion9 Oct 2018Cited by 5 (Europe PMC)

PMID30277094DOI10.1080/03007995.2018.1527303PepBankPUB-30277094

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: Publisher copyright. Results still quote short attributed sentences.

Results from this study10

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

01HumanNon-randomized trialOther
In the open-label plecanatide IBS-C study, 1842 of 2272 patients (81.1%) completed the study.
In plain wordsIn the plecanatide IBS-C study, 1842 of 2272 patients (81.1%) completed the study.
Peptide
Plecanatide
Outcome
Not applicableStudy completion
Study
n = 2,272
Outcome group
Study retention · Whole body
Studied dose
6 mg once daily · up to 53 weeksAs given in this study (human).
Measurements
patients completing study
1842 patients
enrolled patients, plecanatide 6 mg
completion rate
81.1%
enrolled patients, plecanatide 6 mg
Source sentences
Summary
Of the 2272 patients enrolled, 1842 (81.1%) completed the study.
2 context sentences(design, population, supporting numbers)
Summary · context
This open-label, multi-center, fixed-dose study (NCT02706483) evaluated the long-term safety and tolerability of plecanatide for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).
Summary · context
Safety and tolerability of once-daily plecanatide 6 mg for up to 53 weeks was assessed in patients with IBS-C who either had been enrolled in one of the phase 3 studies or were study-naïve but met eligibility criteria of the double-blind studies.
Report a problemFND-3027709401
02HumanNon-randomized trialSafety outcome
In the plecanatide IBS-C study, 27.3% of patients experienced adverse events.
In plain wordsIn the plecanatide IBS-C study, 27.3% of patients had adverse events.
Peptide
Plecanatide
Outcome
Not applicableAdverse events
Study
n = 2,272
Outcome group
Adverse events · Gastrointestinal
Studied dose
6 mg once daily · up to 53 weeksAs given in this study (human).
Measurements
patients with adverse events
27.3%
plecanatide 6 mg
Source sentences
Summary
AEs were experienced by 27.3%, and 4.3% discontinued due to an AE.
2 context sentences(design, population, supporting numbers)
Summary · context
This open-label, multi-center, fixed-dose study (NCT02706483) evaluated the long-term safety and tolerability of plecanatide for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).
Summary · context
Safety and tolerability of once-daily plecanatide 6 mg for up to 53 weeks was assessed in patients with IBS-C who either had been enrolled in one of the phase 3 studies or were study-naïve but met eligibility criteria of the double-blind studies.
Report a problemFND-3027709402
03HumanNon-randomized trialSafety outcome
In the plecanatide IBS-C study, 4.3% discontinued because of an adverse event.
In plain wordsIn the plecanatide IBS-C study, 4.3% stopped treatment because of an adverse event.
Peptide
Plecanatide
Outcome
Not applicableDiscontinuation due to adverse events
Study
n = 2,272
Outcome group
Adverse events · Gastrointestinal
Studied dose
6 mg once daily · up to 53 weeksAs given in this study (human).
Measurements
discontinuation due to adverse event
4.3%
plecanatide 6 mg
Source sentences
Summary
AEs were experienced by 27.3%, and 4.3% discontinued due to an AE.
2 context sentences(design, population, supporting numbers)
Summary · context
This open-label, multi-center, fixed-dose study (NCT02706483) evaluated the long-term safety and tolerability of plecanatide for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).
Summary · context
Safety and tolerability of once-daily plecanatide 6 mg for up to 53 weeks was assessed in patients with IBS-C who either had been enrolled in one of the phase 3 studies or were study-naïve but met eligibility criteria of the double-blind studies.
Report a problemFND-3027709403
04HumanNon-randomized trialSafety outcome
In the plecanatide IBS-C study, diarrhea occurred in 6.7% of patients.
In plain wordsIn the plecanatide IBS-C study, diarrhea occurred in 6.7% of patients.
Peptide
Plecanatide
Outcome
Not applicableDiarrhea incidence
Study
n = 2,272
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
6 mg once daily · up to 53 weeksAs given in this study (human).
Measurements
diarrhea incidence
6.7%
plecanatide 6 mg
Source sentences
Summary
The incidence of diarrhea, the most commonly reported AE, was low (6.7%), and declined in frequency over time.
2 context sentences(design, population, supporting numbers)
Summary · context
This open-label, multi-center, fixed-dose study (NCT02706483) evaluated the long-term safety and tolerability of plecanatide for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).
Summary · context
Safety and tolerability of once-daily plecanatide 6 mg for up to 53 weeks was assessed in patients with IBS-C who either had been enrolled in one of the phase 3 studies or were study-naïve but met eligibility criteria of the double-blind studies.
Report a problemFND-3027709405
05HumanNon-randomized trialSafety outcome
In the plecanatide IBS-C study, diarrhea frequency declined over time.
In plain wordsIn the plecanatide IBS-C study, diarrhea became less frequent over time.
Peptide
Plecanatide
Outcome
DecreaseDiarrhea frequency over time
Study
n = 2,272
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
6 mg once daily · up to 53 weeksAs given in this study (human).
Source sentences
Summary
The incidence of diarrhea, the most commonly reported AE, was low (6.7%), and declined in frequency over time.
2 context sentences(design, population, supporting numbers)
Summary · context
This open-label, multi-center, fixed-dose study (NCT02706483) evaluated the long-term safety and tolerability of plecanatide for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).
Summary · context
Safety and tolerability of once-daily plecanatide 6 mg for up to 53 weeks was assessed in patients with IBS-C who either had been enrolled in one of the phase 3 studies or were study-naïve but met eligibility criteria of the double-blind studies.
Report a problemFND-3027709406
06HumanNon-randomized trialSafety outcome
In the plecanatide IBS-C study, diarrhea caused withdrawal in 2.7% of patients.
In plain wordsIn the plecanatide IBS-C study, diarrhea caused withdrawal in 2.7% of patients.
Peptide
Plecanatide
Outcome
Not applicableWithdrawal due to diarrhea
Study
n = 2,272
Outcome group
Adverse events · Gastrointestinal
Studied dose
6 mg once daily · up to 53 weeksAs given in this study (human).
Measurements
withdrawal due to diarrhea
2.7%
plecanatide 6 mg
Source sentences
Summary
Diarrhea was the most common cause of AE-related withdrawals (2.7% of patients).
2 context sentences(design, population, supporting numbers)
Summary · context
This open-label, multi-center, fixed-dose study (NCT02706483) evaluated the long-term safety and tolerability of plecanatide for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).
Summary · context
Safety and tolerability of once-daily plecanatide 6 mg for up to 53 weeks was assessed in patients with IBS-C who either had been enrolled in one of the phase 3 studies or were study-naïve but met eligibility criteria of the double-blind studies.
Report a problemFND-3027709407
07HumanNon-randomized trialSafety outcome
In the plecanatide IBS-C study, 90.3% of adverse events were mild or moderate.
In plain wordsIn the plecanatide IBS-C study, 90.3% of adverse events were mild or moderate.
Peptide
Plecanatide
Outcome
Not applicableAdverse event severity
Study
n: not reported in source
Outcome group
Adverse events · Gastrointestinal
Studied dose
6 mg once daily · up to 53 weeksAs given in this study (human).
Measurements
adverse events mild or moderate
90.3%
adverse events, plecanatide 6 mg
Source sentences
Summary
Most AEs were mild or moderate (90.3%).
2 context sentences(design, population, supporting numbers)
Summary · context
This open-label, multi-center, fixed-dose study (NCT02706483) evaluated the long-term safety and tolerability of plecanatide for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).
Summary · context
Safety and tolerability of once-daily plecanatide 6 mg for up to 53 weeks was assessed in patients with IBS-C who either had been enrolled in one of the phase 3 studies or were study-naïve but met eligibility criteria of the double-blind studies.
Report a problemFND-3027709404
08HumanNon-randomized trialEfficacy outcome
At week 53 or treatment end, 88.2% of plecanatide-treated IBS-C patients reported significant or moderate relief.
In plain wordsAt week 53 or treatment end, 88.2% of plecanatide-treated IBS-C patients reported significant or moderate relief.
Peptide
Plecanatide
Outcome
Not applicableSymptom relief
Study
n: not reported in source
Outcome group
Bowel Function · Gastrointestinal
Studied dose
6 mg once daily · up to 53 weeksAs given in this study (human).
Measurements
patients reporting significant or moderate relief
88.2%
week 53 or end of treatment
Source sentences
Summary
At week 53 or end of treatment, 88.2% of patients reported "significant" or "moderate" relief, 72.4% were "very" or "quite" satisfied with treatment, and 76.6% were "very" or "quite" likely to continue treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
This open-label, multi-center, fixed-dose study (NCT02706483) evaluated the long-term safety and tolerability of plecanatide for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).
Summary · context
Safety and tolerability of once-daily plecanatide 6 mg for up to 53 weeks was assessed in patients with IBS-C who either had been enrolled in one of the phase 3 studies or were study-naïve but met eligibility criteria of the double-blind studies.
Report a problemFND-3027709408
09HumanNon-randomized trialOther
At week 53 or treatment end, 72.4% of plecanatide-treated IBS-C patients were very or quite satisfied.
In plain wordsAt week 53 or treatment end, 72.4% of plecanatide-treated IBS-C patients were very or quite satisfied.
Peptide
Plecanatide
Outcome
Not applicableTreatment satisfaction
Study
n: not reported in source
Outcome group
Patient-reported outcomes · Gastrointestinal
Studied dose
6 mg once daily · up to 53 weeksAs given in this study (human).
Measurements
patients very or quite satisfied
72.4%
week 53 or end of treatment
Source sentences
Summary
At week 53 or end of treatment, 88.2% of patients reported "significant" or "moderate" relief, 72.4% were "very" or "quite" satisfied with treatment, and 76.6% were "very" or "quite" likely to continue treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
This open-label, multi-center, fixed-dose study (NCT02706483) evaluated the long-term safety and tolerability of plecanatide for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).
Summary · context
Safety and tolerability of once-daily plecanatide 6 mg for up to 53 weeks was assessed in patients with IBS-C who either had been enrolled in one of the phase 3 studies or were study-naïve but met eligibility criteria of the double-blind studies.
Report a problemFND-3027709409
10HumanNon-randomized trialOther
At week 53 or treatment end, 76.6% of plecanatide-treated IBS-C patients were very or quite likely to continue treatment.
In plain wordsAt week 53 or treatment end, 76.6% of plecanatide-treated IBS-C patients were very or quite likely to continue treatment.
Peptide
Plecanatide
Outcome
Not applicableDesire to continue treatment
Study
n: not reported in source
Outcome group
Patient-reported outcomes · Gastrointestinal
Studied dose
6 mg once daily · up to 53 weeksAs given in this study (human).
Measurements
patients very or quite likely to continue
76.6%
week 53 or end of treatment
Source sentences
Summary
At week 53 or end of treatment, 88.2% of patients reported "significant" or "moderate" relief, 72.4% were "very" or "quite" satisfied with treatment, and 76.6% were "very" or "quite" likely to continue treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
This open-label, multi-center, fixed-dose study (NCT02706483) evaluated the long-term safety and tolerability of plecanatide for the treatment of adults with irritable bowel syndrome with constipation (IBS-C).
Summary · context
Safety and tolerability of once-daily plecanatide 6 mg for up to 53 weeks was assessed in patients with IBS-C who either had been enrolled in one of the phase 3 studies or were study-naïve but met eligibility criteria of the double-blind studies.
Report a problemFND-3027709410

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 postedNCT02706483

Long Term Safety Study of Plecanatide

Bausch Health Americas, Inc.n = 2,272Jan 2016 to Jun 2017

Irritable Bowel Syndrome

Trial page ClinicalTrials.govUpdated 18 Aug 2020

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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