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Study · Randomized controlled trial · n = 946 · 2021

7 results

Plecanatide Is Effective and Safe in the Treatment for Chronic Idiopathic Constipation: Results of a Phase II Trial.

Barish C, Dorn S, Fogel RP, Patel R, Rosenberg J

Digestive diseases and sciences17 Mar 2020Cited by 7 (Europe PMC)

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 study7

7 results from studies that gave the peptide. 7 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In CIC, plecanatide 0.3 mg increased overall CSBM response versus placebo (P = 0.016).

    In plain wordsIn CIC, plecanatide 0.3 mg increased complete bowel movement response versus placebo.

    Outcome
    IncreaseOverall CSBM response
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    0.3 mg · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Plecanatide 0.3 and 3.0 mg significantly increased overall CSBM responder rates compared with placebo (0.3 mg, P = 0.016; 3.0 mg, P = 0.009).
    2 context sentences
    Summary · context
    A 12-week, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study was conducted in patients aged 18-75 years and diagnosed with CIC based on modified Rome III criteria (< 3 complete spontaneous bowel movements [CSBMs] per week and infrequent loose stools without the use of laxatives).
    Summary · context
    Participants were randomized to placebo or plecanatide 0.3, 1.0, or 3.0 mg.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In CIC, plecanatide 3.0 mg increased overall CSBM response versus placebo (P = 0.009).

    In plain wordsIn CIC, plecanatide 3.0 mg increased complete bowel movement response versus placebo.

    Outcome
    IncreaseOverall CSBM response
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    3.0 mg · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Plecanatide 0.3 and 3.0 mg significantly increased overall CSBM responder rates compared with placebo (0.3 mg, P = 0.016; 3.0 mg, P = 0.009).
    2 context sentences
    Summary · context
    A 12-week, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study was conducted in patients aged 18-75 years and diagnosed with CIC based on modified Rome III criteria (< 3 complete spontaneous bowel movements [CSBMs] per week and infrequent loose stools without the use of laxatives).
    Summary · context
    Participants were randomized to placebo or plecanatide 0.3, 1.0, or 3.0 mg.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In CIC, plecanatide was associated with decreased time to first CSBM versus placebo.

    In plain wordsIn CIC, plecanatide was linked to a shorter time to the first complete bowel movement than placebo.

    Outcome
    DecreaseTime to first CSBM
    Study

    n = 946

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    Dose not stated · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Plecanatide was associated with decreased time to first CSBM, significant increases in CSBM and SBM frequency, and decreased patient-reported constipation severity compared with placebo.
    2 context sentences
    Summary · context
    A 12-week, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study was conducted in patients aged 18-75 years and diagnosed with CIC based on modified Rome III criteria (< 3 complete spontaneous bowel movements [CSBMs] per week and infrequent loose stools without the use of laxatives).
    Summary · context
    Participants were randomized to placebo or plecanatide 0.3, 1.0, or 3.0 mg.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In CIC, plecanatide was associated with significant increases in CSBM frequency versus placebo.

    In plain wordsIn CIC, plecanatide was linked to more frequent complete bowel movements than placebo.

    Outcome
    IncreaseCSBM frequency
    Study

    n = 946

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    Dose not stated · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Plecanatide was associated with decreased time to first CSBM, significant increases in CSBM and SBM frequency, and decreased patient-reported constipation severity compared with placebo.
    2 context sentences
    Summary · context
    A 12-week, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study was conducted in patients aged 18-75 years and diagnosed with CIC based on modified Rome III criteria (< 3 complete spontaneous bowel movements [CSBMs] per week and infrequent loose stools without the use of laxatives).
    Summary · context
    Participants were randomized to placebo or plecanatide 0.3, 1.0, or 3.0 mg.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In CIC, plecanatide was associated with significant increases in SBM frequency versus placebo.

    In plain wordsIn CIC, plecanatide was linked to more frequent bowel movements than placebo.

    Outcome
    IncreaseSBM frequency
    Study

    n = 946

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    Dose not stated · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Plecanatide was associated with decreased time to first CSBM, significant increases in CSBM and SBM frequency, and decreased patient-reported constipation severity compared with placebo.
    2 context sentences
    Summary · context
    A 12-week, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study was conducted in patients aged 18-75 years and diagnosed with CIC based on modified Rome III criteria (< 3 complete spontaneous bowel movements [CSBMs] per week and infrequent loose stools without the use of laxatives).
    Summary · context
    Participants were randomized to placebo or plecanatide 0.3, 1.0, or 3.0 mg.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In CIC, plecanatide was associated with decreased patient-reported constipation severity versus placebo.

    In plain wordsIn CIC, plecanatide was linked to lower patient-reported constipation severity than placebo.

    Outcome
    DecreaseConstipation severity
    Study

    n = 946

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    Dose not stated · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Plecanatide was associated with decreased time to first CSBM, significant increases in CSBM and SBM frequency, and decreased patient-reported constipation severity compared with placebo.
    2 context sentences
    Summary · context
    A 12-week, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study was conducted in patients aged 18-75 years and diagnosed with CIC based on modified Rome III criteria (< 3 complete spontaneous bowel movements [CSBMs] per week and infrequent loose stools without the use of laxatives).
    Summary · context
    Participants were randomized to placebo or plecanatide 0.3, 1.0, or 3.0 mg.
  7. 07HumanNon-randomized trialSafety outcome

    In the CIC trial, diarrhea was the most frequently reported treatment-emergent adverse event.

    In plain wordsIn the CIC trial, diarrhea was the most frequently reported adverse event.

    Outcome
    Direction not reportedDiarrhea
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Diarrhea was the most frequently reported treatment-emergent adverse event.
    2 context sentences
    Summary · context
    A 12-week, multicenter, randomized, double-blind, placebo-controlled, dose-ranging study was conducted in patients aged 18-75 years and diagnosed with CIC based on modified Rome III criteria (< 3 complete spontaneous bowel movements [CSBMs] per week and infrequent loose stools without the use of laxatives).
    Summary · context
    Participants were randomized to placebo or plecanatide 0.3, 1.0, or 3.0 mg.

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

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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