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Study · Randomized controlled trial · 2018

11 results

Efficacy, safety, and tolerability of plecanatide in patients with irritable bowel syndrome with constipation: results of two phase 3 randomized clinical trials.

Brenner DM, Fogel R, Dorn SD, Krause R, Eng P, Kirshoff R, Nguyen A, Crozier RA, Magnus L, Griffin PH

The American journal of gastroenterology15 Mar 2018Cited by 125 (Europe PMC)

PMID29545635 (opens in a new tab)DOI10.1038/s41395-018-0026-7 (opens in a new tab)PepBankPUB-29545635
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 study11

11 results from studies that gave the peptide. 11 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In IBS-C Study 1, overall response was 30.2% with plecanatide 3 mg versus 17.8% with placebo (P < 0.001).

    In plain wordsIn IBS-C Study 1, response was 30.2% with plecanatide 3 mg versus 17.8% with placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseOverall response in Study 1
    Study

    n: not reported in source

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

    Measurements

    overall responders
    30.2%
    Study 1, plecanatide 3 mg
    overall responders
    17.8%
    Study 1, placebo

    Source sentences

    Summary
    The percentage of overall responders in Study 1 was 30.2% and 29.5% for plecanatide 3 and 6 mg, respectively, vs. 17.8% placebo (P < 0.001 for each dose vs. placebo), and in Study 2 was 21.5% (P = 0.009) and 24.0% (P < 0.001) for plecanatide 3 and 6 mg, respectively, compared to 14.2% for placebo.
    2 context sentences
    Summary · context
    Two identical, phase 3, randomized, double-blind, placebo-controlled trials evaluated the efficacy and safety of plecanatide in patients with irritable bowel syndrome with constipation (IBS-C).
    Summary · context
    Adults meeting Rome III criteria for IBS-C were randomized (1:1:1) to placebo or plecanatide (3 or 6 mg) for 12 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In IBS-C Study 1, overall response was 29.5% with plecanatide 6 mg versus 17.8% with placebo (P < 0.001).

    In plain wordsIn IBS-C Study 1, response was 29.5% with plecanatide 6 mg versus 17.8% with placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseOverall response in Study 1
    Study

    n: not reported in source

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

    Measurements

    overall responders
    29.5%
    Study 1, plecanatide 6 mg
    overall responders
    17.8%
    Study 1, placebo

    Source sentences

    Summary
    The percentage of overall responders in Study 1 was 30.2% and 29.5% for plecanatide 3 and 6 mg, respectively, vs. 17.8% placebo (P < 0.001 for each dose vs. placebo), and in Study 2 was 21.5% (P = 0.009) and 24.0% (P < 0.001) for plecanatide 3 and 6 mg, respectively, compared to 14.2% for placebo.
    2 context sentences
    Summary · context
    Two identical, phase 3, randomized, double-blind, placebo-controlled trials evaluated the efficacy and safety of plecanatide in patients with irritable bowel syndrome with constipation (IBS-C).
    Summary · context
    Adults meeting Rome III criteria for IBS-C were randomized (1:1:1) to placebo or plecanatide (3 or 6 mg) for 12 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In IBS-C Study 2, overall response was 21.5% with plecanatide 3 mg versus 14.2% with placebo (P = 0.009).

    In plain wordsIn IBS-C Study 2, response was 21.5% with plecanatide 3 mg versus 14.2% with placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseOverall response in Study 2
    Study

    n: not reported in source

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

    Measurements

    overall responders
    21.5%
    Study 2, plecanatide 3 mg
    overall responders
    14.2%
    Study 2, placebo

    Source sentences

    Summary
    The percentage of overall responders in Study 1 was 30.2% and 29.5% for plecanatide 3 and 6 mg, respectively, vs. 17.8% placebo (P < 0.001 for each dose vs. placebo), and in Study 2 was 21.5% (P = 0.009) and 24.0% (P < 0.001) for plecanatide 3 and 6 mg, respectively, compared to 14.2% for placebo.
    2 context sentences
    Summary · context
    Two identical, phase 3, randomized, double-blind, placebo-controlled trials evaluated the efficacy and safety of plecanatide in patients with irritable bowel syndrome with constipation (IBS-C).
    Summary · context
    Adults meeting Rome III criteria for IBS-C were randomized (1:1:1) to placebo or plecanatide (3 or 6 mg) for 12 weeks.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In IBS-C Study 2, overall response was 24.0% with plecanatide 6 mg versus 14.2% with placebo (P < 0.001).

    In plain wordsIn IBS-C Study 2, response was 24.0% with plecanatide 6 mg versus 14.2% with placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseOverall response in Study 2
    Study

    n: not reported in source

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

    Measurements

    overall responders
    24%
    Study 2, plecanatide 6 mg
    overall responders
    14.2%
    Study 2, placebo

    Source sentences

    Summary
    The percentage of overall responders in Study 1 was 30.2% and 29.5% for plecanatide 3 and 6 mg, respectively, vs. 17.8% placebo (P < 0.001 for each dose vs. placebo), and in Study 2 was 21.5% (P = 0.009) and 24.0% (P < 0.001) for plecanatide 3 and 6 mg, respectively, compared to 14.2% for placebo.
    2 context sentences
    Summary · context
    Two identical, phase 3, randomized, double-blind, placebo-controlled trials evaluated the efficacy and safety of plecanatide in patients with irritable bowel syndrome with constipation (IBS-C).
    Summary · context
    Adults meeting Rome III criteria for IBS-C were randomized (1:1:1) to placebo or plecanatide (3 or 6 mg) for 12 weeks.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In IBS-C, plecanatide significantly improved secondary stool frequency/consistency, straining, and abdominal symptom endpoints versus placebo.

    In plain wordsIn IBS-C, plecanatide improved secondary bowel and abdominal symptom endpoints versus placebo.

    Peptide
    Plecanatide
    Outcome
    Direction not reportedSecondary bowel and abdominal symptom endpoints
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    3 or 6 mg · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    All secondary end points (stool frequency/consistency, straining, abdominal symptoms) showed statistically significant improvements compared with placebo.
    2 context sentences
    Summary · context
    Two identical, phase 3, randomized, double-blind, placebo-controlled trials evaluated the efficacy and safety of plecanatide in patients with irritable bowel syndrome with constipation (IBS-C).
    Summary · context
    Adults meeting Rome III criteria for IBS-C were randomized (1:1:1) to placebo or plecanatide (3 or 6 mg) for 12 weeks.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In both IBS-C studies, plecanatide 3 mg significantly increased sustained efficacy response versus placebo.

    In plain wordsIn both IBS-C studies, plecanatide 3 mg increased sustained response versus placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseSustained efficacy response
    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
    The percentage of sustained efficacy responders (overall responders plus weekly responders for ≥2 of last 4 weeks of the 12-week treatment period) was significantly greater for both doses of plecanatide vs. placebo across both studies.
    2 context sentences
    Summary · context
    Two identical, phase 3, randomized, double-blind, placebo-controlled trials evaluated the efficacy and safety of plecanatide in patients with irritable bowel syndrome with constipation (IBS-C).
    Summary · context
    Adults meeting Rome III criteria for IBS-C were randomized (1:1:1) to placebo or plecanatide (3 or 6 mg) for 12 weeks.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In both IBS-C studies, plecanatide 6 mg significantly increased sustained efficacy response versus placebo.

    In plain wordsIn both IBS-C studies, plecanatide 6 mg increased sustained response versus placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseSustained efficacy response
    Study

    n: not reported in source

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

    Source sentences

    Summary
    The percentage of sustained efficacy responders (overall responders plus weekly responders for ≥2 of last 4 weeks of the 12-week treatment period) was significantly greater for both doses of plecanatide vs. placebo across both studies.
    2 context sentences
    Summary · context
    Two identical, phase 3, randomized, double-blind, placebo-controlled trials evaluated the efficacy and safety of plecanatide in patients with irritable bowel syndrome with constipation (IBS-C).
    Summary · context
    Adults meeting Rome III criteria for IBS-C were randomized (1:1:1) to placebo or plecanatide (3 or 6 mg) for 12 weeks.
  8. 08HumanRandomized controlled trialSafety outcome

    In IBS-C, diarrhea occurred in 4.3% with plecanatide 3 mg versus 1.0% with placebo.

    In plain wordsIn IBS-C, diarrhea occurred in 4.3% with plecanatide 3 mg versus 1.0% with placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseDiarrhea
    Study

    n: not reported in source

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

    Measurements

    diarrhea incidence
    4.3%
    plecanatide 3 mg
    diarrhea incidence
    1%
    placebo

    Source sentences

    Summary
    The most common AE was diarrhea (3 mg, 4.3%; 6 mg, 4.0%; placebo, 1.0%).
    2 context sentences
    Summary · context
    Two identical, phase 3, randomized, double-blind, placebo-controlled trials evaluated the efficacy and safety of plecanatide in patients with irritable bowel syndrome with constipation (IBS-C).
    Summary · context
    Adults meeting Rome III criteria for IBS-C were randomized (1:1:1) to placebo or plecanatide (3 or 6 mg) for 12 weeks.
  9. 09HumanRandomized controlled trialSafety outcome

    In IBS-C, diarrhea occurred in 4.0% with plecanatide 6 mg versus 1.0% with placebo.

    In plain wordsIn IBS-C, diarrhea occurred in 4.0% with plecanatide 6 mg versus 1.0% with placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseDiarrhea
    Study

    n: not reported in source

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

    Measurements

    diarrhea incidence
    4%
    plecanatide 6 mg
    diarrhea incidence
    1%
    placebo

    Source sentences

    Summary
    The most common AE was diarrhea (3 mg, 4.3%; 6 mg, 4.0%; placebo, 1.0%).
    2 context sentences
    Summary · context
    Two identical, phase 3, randomized, double-blind, placebo-controlled trials evaluated the efficacy and safety of plecanatide in patients with irritable bowel syndrome with constipation (IBS-C).
    Summary · context
    Adults meeting Rome III criteria for IBS-C were randomized (1:1:1) to placebo or plecanatide (3 or 6 mg) for 12 weeks.
  10. 10HumanRandomized controlled trialSafety outcome

    In IBS-C, diarrhea caused discontinuation in 1.2% with plecanatide 3 mg versus 0 with placebo.

    In plain wordsIn IBS-C, diarrhea caused discontinuation in 1.2% with plecanatide 3 mg versus 0 with placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseDiscontinuation due to diarrhea
    Study

    n: not reported in source

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

    Measurements

    discontinuation due to diarrhea
    1.2%
    plecanatide 3 mg
    discontinuation due to diarrhea
    0%
    placebo

    Source sentences

    Summary
    Discontinuation due to diarrhea was infrequent (3 mg, 1.2%; 6 mg, 1.4%; placebo, 0).
    2 context sentences
    Summary · context
    Two identical, phase 3, randomized, double-blind, placebo-controlled trials evaluated the efficacy and safety of plecanatide in patients with irritable bowel syndrome with constipation (IBS-C).
    Summary · context
    Adults meeting Rome III criteria for IBS-C were randomized (1:1:1) to placebo or plecanatide (3 or 6 mg) for 12 weeks.
  11. 11HumanRandomized controlled trialSafety outcome

    In IBS-C, diarrhea caused discontinuation in 1.4% with plecanatide 6 mg versus 0 with placebo.

    In plain wordsIn IBS-C, diarrhea caused discontinuation in 1.4% with plecanatide 6 mg versus 0 with placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseDiscontinuation due to diarrhea
    Study

    n: not reported in source

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

    Measurements

    discontinuation due to diarrhea
    1.4%
    plecanatide 6 mg
    discontinuation due to diarrhea
    0%
    placebo

    Source sentences

    Summary
    Discontinuation due to diarrhea was infrequent (3 mg, 1.2%; 6 mg, 1.4%; placebo, 0).
    2 context sentences
    Summary · context
    Two identical, phase 3, randomized, double-blind, placebo-controlled trials evaluated the efficacy and safety of plecanatide in patients with irritable bowel syndrome with constipation (IBS-C).
    Summary · context
    Adults meeting Rome III criteria for IBS-C were randomized (1:1:1) to placebo or plecanatide (3 or 6 mg) for 12 weeks.

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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