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Study · Randomized controlled trial · n = 648 · 2025

8 results

Efficacy and Safety of Plecanatide in Chinese Patients with Functional Constipation: A Phase III Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial.

Bai T, Xu Z, Zhen Y, Liao A, Wang B, Zhao R, Zhu Y, Dai N, Liu S, Zhao H, Chen X, Huang K and 30 more

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Xu M, Zhou W, Xu B, Ye B, Zou D, Zhang H, Shi R, Zhang J, Ai Y, Fang X, Lin L, Zhang X, Zhang L, Wang J, Jiang Y, Cui J, Zhang M, Ding X, Zhou Z, Yan P, Li X, Jiang B, Liu Y, Ma Y, Yang S, Wang X, Wu Y, Wu J, Chen H, Hou X

Drugs26 Jun 2025

PMID40571893 (opens in a new tab)DOI10.1007/s40265-025-02205-w (opens in a new tab)PepBankPUB-40571893
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 study8

8 results from studies that gave the peptide. 8 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In Chinese patients with functional constipation, durable overall CSBM response was 23.5% with plecanatide versus 10.2% with placebo after 12 weeks (p < 0.001).

    In plain wordsIn Chinese patients with functional constipation, plecanatide increased durable CSBM response versus placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseDurable overall CSBM response
    Study

    n = 648

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

    Measurements

    Durable overall CSBM response rate
    23.5 percent
    plecanatide 3 mg
    Durable overall CSBM response rate
    10.2 percent
    placebo

    Source sentences

    Summary
    After 12 weeks of continuous treatment, the durable overall CSBM response rates were 23.5% in the plecanatide group and 10.2% in the placebo group (p  <  0.001).
    2 context sentences
    Summary · context
    This phase III, randomized, double-blind, placebo-controlled trial was conducted across 40 hospitals in China.
    Summary · context
    A total of 648 patients with FC were randomly assigned in a ratio of 1:1 to receive either plecanatide 3 mg or placebo for 12 weeks, followed by a 2-week follow-up.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Chinese patients with functional constipation, all other secondary efficacy endpoints improved significantly with plecanatide versus placebo.

    In plain wordsIn Chinese patients with functional constipation, plecanatide improved other secondary efficacy endpoints versus placebo.

    Peptide
    Plecanatide
    Outcome
    Direction not reportedOther secondary efficacy endpoints
    Study

    n = 648

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

    Source sentences

    Summary
    In addition, all other secondary efficacy endpoints showed statistically significant improvements with plecanatide compared with placebo.
    2 context sentences
    Summary · context
    This phase III, randomized, double-blind, placebo-controlled trial was conducted across 40 hospitals in China.
    Summary · context
    A total of 648 patients with FC were randomly assigned in a ratio of 1:1 to receive either plecanatide 3 mg or placebo for 12 weeks, followed by a 2-week follow-up.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In Chinese patients with functional constipation, plecanatide significantly increased mean weekly CSBM frequency versus placebo throughout treatment (1.89 versus 0.9).

    In plain wordsIn Chinese patients with functional constipation, plecanatide increased weekly CSBM frequency versus placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseWeekly CSBM frequency
    Study

    n = 648

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

    Measurements

    Mean weekly CSBM frequency
    1.89 per week
    plecanatide
    Mean weekly CSBM frequency
    0.9 per week
    placebo

    Source sentences

    Summary
    Plecanatide significantly increased the mean weekly frequency of CSBM (1.89 vs 0.9) and SBM (2.33 vs 1.03) compared with placebo throughout the treatment period.
    2 context sentences
    Summary · context
    This phase III, randomized, double-blind, placebo-controlled trial was conducted across 40 hospitals in China.
    Summary · context
    A total of 648 patients with FC were randomly assigned in a ratio of 1:1 to receive either plecanatide 3 mg or placebo for 12 weeks, followed by a 2-week follow-up.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In Chinese patients with functional constipation, plecanatide significantly increased mean weekly SBM frequency versus placebo throughout treatment (2.33 versus 1.03).

    In plain wordsIn Chinese patients with functional constipation, plecanatide increased weekly SBM frequency versus placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseWeekly SBM frequency
    Study

    n = 648

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

    Measurements

    Mean weekly SBM frequency
    2.33 per week
    plecanatide
    Mean weekly SBM frequency
    1.03 per week
    placebo

    Source sentences

    Summary
    Plecanatide significantly increased the mean weekly frequency of CSBM (1.89 vs 0.9) and SBM (2.33 vs 1.03) compared with placebo throughout the treatment period.
    2 context sentences
    Summary · context
    This phase III, randomized, double-blind, placebo-controlled trial was conducted across 40 hospitals in China.
    Summary · context
    A total of 648 patients with FC were randomly assigned in a ratio of 1:1 to receive either plecanatide 3 mg or placebo for 12 weeks, followed by a 2-week follow-up.
  5. 05HumanRandomized controlled trialSafety outcome

    In Chinese patients with functional constipation, treatment-related diarrhea occurred in 4.3% with plecanatide versus 0.6% with placebo (p = 0.002).

    In plain wordsIn Chinese patients with functional constipation, treatment-related diarrhea occurred more often with plecanatide than placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseTreatment-related diarrhea
    Study

    n = 648

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    3 mg · 12 weeksAs given in this study (human).

    Measurements

    Treatment-related emergent diarrhea
    4.3 percent
    plecanatide
    Treatment-related emergent diarrhea
    0.6 percent
    placebo

    Source sentences

    Summary
    The most common treatment-related emergent adverse event was diarrhea, which occurred in 4.3% of plecanatide-treated patients and 0.6% of placebo-treated patients (p = 0.002).
    2 context sentences
    Summary · context
    This phase III, randomized, double-blind, placebo-controlled trial was conducted across 40 hospitals in China.
    Summary · context
    A total of 648 patients with FC were randomly assigned in a ratio of 1:1 to receive either plecanatide 3 mg or placebo for 12 weeks, followed by a 2-week follow-up.
  6. 06HumanNon-randomized trialPharmacokinetics

    In Chinese patients with functional constipation, plasma plecanatide remained below 0.500 ng/ml at all assessed time points.

    In plain wordsIn Chinese patients with functional constipation, plasma plecanatide remained below the quantification limit.

    Peptide
    Plecanatide
    Outcome
    Not applicablePlasma plecanatide concentration
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    3 mg · 12 weeksAs given in this study (human).

    Measurements

    Plasma plecanatide concentration
    < 0.5 ng/ml
    all assessed time points; below lower limit of quantification

    Source sentences

    Summary
    Plasma concentrations of plecanatide and its metabolite SP-338 remained below the lower limit of quantification (0.500 ng/ml) at all assessed time points.
    2 context sentences
    Summary · context
    This phase III, randomized, double-blind, placebo-controlled trial was conducted across 40 hospitals in China.
    Summary · context
    A total of 648 patients with FC were randomly assigned in a ratio of 1:1 to receive either plecanatide 3 mg or placebo for 12 weeks, followed by a 2-week follow-up.
  7. 07HumanNon-randomized trialPharmacokinetics

    In Chinese patients with functional constipation given plecanatide, plasma metabolite SP-338 remained below 0.500 ng/ml at all assessed time points.

    In plain wordsIn Chinese patients with functional constipation given plecanatide, its metabolite remained below the quantification limit.

    Peptide
    Plecanatide
    Outcome
    Not applicablePlasma SP-338 concentration
    Study

    n: not reported in source

    Outcome group
    Pharmacokinetics · Pharmacology
    Studied dose
    3 mg · 12 weeksAs given in this study (human).

    Measurements

    Plasma SP-338 concentration
    < 0.5 ng/ml
    all assessed time points; below lower limit of quantification

    Source sentences

    Summary
    Plasma concentrations of plecanatide and its metabolite SP-338 remained below the lower limit of quantification (0.500 ng/ml) at all assessed time points.
    2 context sentences
    Summary · context
    This phase III, randomized, double-blind, placebo-controlled trial was conducted across 40 hospitals in China.
    Summary · context
    A total of 648 patients with FC were randomly assigned in a ratio of 1:1 to receive either plecanatide 3 mg or placebo for 12 weeks, followed by a 2-week follow-up.
  8. 08HumanObservational studyEfficacy outcome

    In Chinese plecanatide non-responders with functional constipation, SBM frequency improved significantly versus placebo over 12 weeks.

    In plain wordsIn Chinese plecanatide non-responders with functional constipation, SBM frequency improved versus placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseSBM frequency in non-responders
    Study

    n: not reported in source

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

    Source sentences

    Summary
    Even among plecanatide non-responders, a significant improvement in SBM frequency compared with placebo was observed over the 12-week treatment period.
    2 context sentences
    Summary · context
    This phase III, randomized, double-blind, placebo-controlled trial was conducted across 40 hospitals in China.
    Summary · context
    A total of 648 patients with FC were randomly assigned in a ratio of 1:1 to receive either plecanatide 3 mg or placebo for 12 weeks, followed by a 2-week follow-up.

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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