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Study · Non-randomized trial · 2018

10 results

Safety and tolerability of plecanatide in patients with chronic idiopathic constipation: long-term evidence from an open-label study.

Barish CF, Griffin P

Current medical research and opinion2 Feb 2018Cited by 21 (Europe PMC)

PMID29343131 (opens in a new tab)DOI10.1080/03007995.2018.1430024 (opens in a new tab)PepBankPUB-29343131
Publisher pagePubMedAsk about this study
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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: Publisher copyright. Results still quote short attributed sentences.

Results from this study10

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

  1. 01HumanNon-randomized trialOther

    At study closure, 1932 plecanatide exposures (81.5%) completed or continued treatment in the CIC study.

    In plain wordsAt study closure, 1932 plecanatide exposures (81.5%) completed or continued treatment in the CIC study.

    Peptide
    Plecanatide
    Outcome
    Not applicableCompletion or ongoing treatment
    Study

    n: not reported in source

    Outcome group
    Study retention · Whole body
    Studied dose
    3 or 6 mg once daily · oral · up to 72 weeksAs given in this study (human).

    Measurements

    patient exposures completed or still receiving study drug
    1932 patient exposures
    of 2370 patient exposures
    completed or still receiving study drug
    81.5%
    patient exposures

    Source sentences

    Summary
    At the time of study closure, 1932 (81.5%) had completed or were still receiving study drug.
    3 context sentences
    Summary · context
    There were 2370 patient exposures in this study, with the vast majority (90.5%) receiving treatment with plecanatide 6 mg.
    Summary · context
    This multi-center, fixed-dose, open-label study evaluated the long-term safety and tolerability of once-daily oral plecanatide for the treatment of adults with chronic idiopathic constipation (CIC).
    Summary · context
    Enrolled patients received plecanatide (3 or 6 mg) for up to 72 weeks.
  2. 02HumanNon-randomized trialSafety outcome

    In the open-label CIC study, plecanatide treatment-emergent adverse events were qualitatively and quantitatively similar to prior double-blind studies.

    In plain wordsPlecanatide adverse events in the open-label CIC study resembled those in prior double-blind studies.

    Peptide
    Plecanatide
    Outcome
    Direction not reportedTreatment-emergent adverse events relative to prior studies
    Study

    n: not reported in source

    Comparator
    Prior double-blind studies
    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    3 or 6 mg once daily · oral · up to 72 weeksAs given in this study (human).

    Source sentences

    Summary
    TEAEs were qualitatively and quantitatively similar to those observed in prior double-blind studies.
    2 context sentences
    Summary · context
    This multi-center, fixed-dose, open-label study evaluated the long-term safety and tolerability of once-daily oral plecanatide for the treatment of adults with chronic idiopathic constipation (CIC).
    Summary · context
    Enrolled patients received plecanatide (3 or 6 mg) for up to 72 weeks.
  3. 03HumanNon-randomized trialSafety outcome

    In the open-label plecanatide CIC study, diarrhea occurred in 7.1% of patients.

    In plain wordsIn the open-label plecanatide CIC study, diarrhea occurred in 7.1% of patients.

    Peptide
    Plecanatide
    Outcome
    Not applicableDiarrhea
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    3 or 6 mg once daily · oral · up to 72 weeksAs given in this study (human).

    Measurements

    diarrhea incidence
    7.1%
    treatment-emergent adverse events, plecanatide 3 or 6 mg

    Source sentences

    Summary
    The most common TEAEs were diarrhea (7.1%) and urinary tract infection (2.2%).
    2 context sentences
    Summary · context
    This multi-center, fixed-dose, open-label study evaluated the long-term safety and tolerability of once-daily oral plecanatide for the treatment of adults with chronic idiopathic constipation (CIC).
    Summary · context
    Enrolled patients received plecanatide (3 or 6 mg) for up to 72 weeks.
  4. 04HumanNon-randomized trialSafety outcome

    In the open-label plecanatide CIC study, urinary tract infection occurred in 2.2% of patients.

    In plain wordsIn the open-label plecanatide CIC study, urinary tract infection occurred in 2.2% of patients.

    Peptide
    Plecanatide
    Outcome
    Not applicableUrinary tract infection
    Study

    n: not reported in source

    Outcome group
    Adverse events · Kidney and urinary
    Studied dose
    3 or 6 mg once daily · oral · up to 72 weeksAs given in this study (human).

    Measurements

    urinary tract infection incidence
    2.2%
    treatment-emergent adverse events, plecanatide 3 or 6 mg

    Source sentences

    Summary
    The most common TEAEs were diarrhea (7.1%) and urinary tract infection (2.2%).
    2 context sentences
    Summary · context
    This multi-center, fixed-dose, open-label study evaluated the long-term safety and tolerability of once-daily oral plecanatide for the treatment of adults with chronic idiopathic constipation (CIC).
    Summary · context
    Enrolled patients received plecanatide (3 or 6 mg) for up to 72 weeks.
  5. 05HumanNon-randomized trialSafety outcome

    In the open-label plecanatide CIC study, treatment-emergent adverse events caused discontinuation in 5.3% of patients.

    In plain wordsIn the plecanatide CIC study, adverse events caused discontinuation in 5.3% of patients.

    Peptide
    Plecanatide
    Outcome
    Not applicableDiscontinuation due to adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    3 or 6 mg once daily · oral · up to 72 weeksAs given in this study (human).

    Measurements

    discontinuation due to treatment-emergent adverse events
    5.3%
    plecanatide 3 or 6 mg

    Source sentences

    Summary
    TEAEs leading to discontinuation occurred in 5.3% of patients, with diarrhea leading to discontinuation in 3.1%.
    2 context sentences
    Summary · context
    This multi-center, fixed-dose, open-label study evaluated the long-term safety and tolerability of once-daily oral plecanatide for the treatment of adults with chronic idiopathic constipation (CIC).
    Summary · context
    Enrolled patients received plecanatide (3 or 6 mg) for up to 72 weeks.
  6. 06HumanNon-randomized trialSafety outcome

    In the open-label plecanatide CIC study, diarrhea caused discontinuation in 3.1% of patients.

    In plain wordsIn the open-label plecanatide CIC study, diarrhea caused discontinuation in 3.1% of patients.

    Peptide
    Plecanatide
    Outcome
    Not applicableDiscontinuation due to diarrhea
    Study

    n: not reported in source

    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    3 or 6 mg once daily · oral · up to 72 weeksAs given in this study (human).

    Measurements

    discontinuation due to diarrhea
    3.1%
    plecanatide 3 or 6 mg

    Source sentences

    Summary
    TEAEs leading to discontinuation occurred in 5.3% of patients, with diarrhea leading to discontinuation in 3.1%.
    2 context sentences
    Summary · context
    This multi-center, fixed-dose, open-label study evaluated the long-term safety and tolerability of once-daily oral plecanatide for the treatment of adults with chronic idiopathic constipation (CIC).
    Summary · context
    Enrolled patients received plecanatide (3 or 6 mg) for up to 72 weeks.
  7. 07HumanNon-randomized trialSafety outcome

    Most treatment-emergent adverse events in plecanatide-treated CIC patients were mild or moderate.

    In plain wordsMost adverse events in plecanatide-treated CIC patients were mild or moderate.

    Peptide
    Plecanatide
    Outcome
    Not applicableAdverse event severity
    Study

    n: not reported in source

    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    3 or 6 mg once daily · oral · up to 72 weeksAs given in this study (human).

    Source sentences

    Summary
    Most TEAEs were mild/moderate in severity and were generally considered not related to plecanatide treatment.
    2 context sentences
    Summary · context
    This multi-center, fixed-dose, open-label study evaluated the long-term safety and tolerability of once-daily oral plecanatide for the treatment of adults with chronic idiopathic constipation (CIC).
    Summary · context
    Enrolled patients received plecanatide (3 or 6 mg) for up to 72 weeks.
  8. 08HumanNon-randomized trialSafety outcome

    Treatment-emergent adverse events in the CIC study were generally considered unrelated to plecanatide.

    In plain wordsInvestigators generally considered adverse events in the CIC study unrelated to plecanatide.

    Peptide
    Plecanatide
    Outcome
    Not applicableAdverse event attribution
    Study

    n: not reported in source

    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    3 or 6 mg once daily · oral · up to 72 weeksAs given in this study (human).

    Source sentences

    Summary
    Most TEAEs were mild/moderate in severity and were generally considered not related to plecanatide treatment.
    2 context sentences
    Summary · context
    This multi-center, fixed-dose, open-label study evaluated the long-term safety and tolerability of once-daily oral plecanatide for the treatment of adults with chronic idiopathic constipation (CIC).
    Summary · context
    Enrolled patients received plecanatide (3 or 6 mg) for up to 72 weeks.
  9. 09HumanNon-randomized trialOther

    At treatment end, plecanatide-treated CIC patients had a median satisfaction score of 4.0, indicating quite satisfied.

    In plain wordsAt treatment end, plecanatide-treated CIC patients had a median satisfaction score of 4.0, indicating quite satisfied.

    Peptide
    Plecanatide
    Outcome
    Not applicableTreatment satisfaction
    Study

    n: not reported in source

    Outcome group
    Patient-reported outcomes · Gastrointestinal
    Studied dose
    3 or 6 mg once daily · oral · up to 72 weeksAs given in this study (human).

    Measurements

    median treatment satisfaction score
    4 score
    end of treatment

    Source sentences

    Summary
    At the end of treatment, the median score for treatment satisfaction was 4.0 (quite satisfied), and the median score for treatment continuation was 4.0 (quite likely).
    2 context sentences
    Summary · context
    This multi-center, fixed-dose, open-label study evaluated the long-term safety and tolerability of once-daily oral plecanatide for the treatment of adults with chronic idiopathic constipation (CIC).
    Summary · context
    Enrolled patients received plecanatide (3 or 6 mg) for up to 72 weeks.
  10. 10HumanNon-randomized trialOther

    At treatment end, plecanatide-treated CIC patients had a median continuation score of 4.0, indicating quite likely.

    In plain wordsAt treatment end, plecanatide-treated CIC patients had a median continuation score of 4.0, indicating quite likely.

    Peptide
    Plecanatide
    Outcome
    Not applicableDesire to continue treatment
    Study

    n: not reported in source

    Outcome group
    Patient-reported outcomes · Gastrointestinal
    Studied dose
    3 or 6 mg once daily · oral · up to 72 weeksAs given in this study (human).

    Measurements

    median treatment continuation score
    4 score
    end of treatment

    Source sentences

    Summary
    At the end of treatment, the median score for treatment satisfaction was 4.0 (quite satisfied), and the median score for treatment continuation was 4.0 (quite likely).
    2 context sentences
    Summary · context
    This multi-center, fixed-dose, open-label study evaluated the long-term safety and tolerability of once-daily oral plecanatide for the treatment of adults with chronic idiopathic constipation (CIC).
    Summary · context
    Enrolled patients received plecanatide (3 or 6 mg) for up to 72 weeks.

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 postedNCT01919697

Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)

Bausch Health Americas, Inc.n = 2,370Aug 2013 to Mar 2016

Chronic Idiopathic Constipation

Trial pageClinicalTrials.govUpdated 2 Jul 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.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. 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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