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Study · Randomized controlled trial · n = 839 · 2018

5 results

Linaclotide in irritable bowel syndrome with constipation: A Phase 3 randomized trial in China and other regions.

Yang Y, Fang J, Guo X, Dai N, Shen X, Yang Y, Sun J, Bhandari BR, Reasner DS, Cronin JA, Currie MG, Johnston JM and 4 more

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Zeng P, Montreewasuwat N, Chen GZ, Lim S

Journal of gastroenterology and hepatology12 Mar 2018Cited by 39 (Europe PMC)

PMID29319191 (opens in a new tab)DOI10.1111/jgh.14086 (opens in a new tab)PepBankPUB-29319191
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 study5

5 results from studies that gave the peptide. 5 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In IBS-C patients, abdominal pain/discomfort response was 60.0% with linaclotide versus 48.8% with placebo (P < 0.05).

    In plain wordsIn IBS-C patients, pain and discomfort response was higher with linaclotide than placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseAbdominal pain/discomfort response
    Study

    n = 839

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Pain · Gastrointestinal
    Studied dose
    290 μg once daily · oralAs given in this study (human).

    Measurements

    Abdominal pain/discomfort responders
    60%
    linaclotide 290 μg
    Abdominal pain/discomfort responders
    48.8%
    placebo

    Source sentences

    Summary
    Co-primary responder criteria were met by 60.0% of linaclotide patients versus 48.8% of placebo patients for abdominal pain/discomfort (≥ 30% decrease for ≥ 6/12 weeks; P < 0.05),
    1 context sentence
    Summary · context
    This Phase 3, double-blind trial randomized IBS-C patients to once-daily oral 290-μg linaclotide or placebo at centers in China, North America, and Oceania.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In IBS-C patients, IBS relief response was 31.7% with linaclotide versus 15.4% with placebo (P < 0.0001).

    In plain wordsIn IBS-C patients, IBS relief response was higher with linaclotide than placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseIBS degree of relief response
    Study

    n = 839

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    290 μg once daily · oralAs given in this study (human).

    Measurements

    IBS degree of relief responders
    31.7%
    linaclotide 290 μg
    IBS degree of relief responders
    15.4%
    placebo

    Source sentences

    Summary
    and 31.7% of linaclotide versus 15.4% of placebo patients for IBS degree of relief (score ≤ 2 for ≥ 6/12 weeks; P < 0.0001).
    1 context sentence
    Summary · context
    This Phase 3, double-blind trial randomized IBS-C patients to once-daily oral 290-μg linaclotide or placebo at centers in China, North America, and Oceania.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In IBS-C patients, linaclotide improved bowel frequency, stool consistency, straining, pain, discomfort, and bloating versus placebo over 12 weeks (all P < 0.0001).

    In plain wordsIn IBS-C patients, linaclotide improved the reported bowel and abdominal secondary outcomes compared with placebo at 12 weeks.

    Peptide
    Linaclotide
    Outcome
    Direction not reportedAggregate bowel and abdominal secondary endpoints
    Study

    n = 839

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    290 μg once daily · oralAs given in this study (human).

    Source sentences

    Summary
    Secondary 12-week change-from-baseline endpoints (spontaneous bowel movement/complete spontaneous bowel movement frequency, stool consistency, straining, abdominal pain, abdominal discomfort, and abdominal bloating) were significantly improved with linaclotide versus placebo (all P < 0.0001).
    1 context sentence
    Summary · context
    This Phase 3, double-blind trial randomized IBS-C patients to once-daily oral 290-μg linaclotide or placebo at centers in China, North America, and Oceania.
  4. 04HumanRandomized controlled trialSafety outcome

    In IBS-C patients, diarrhea occurred in 9.4% with linaclotide versus 1.2% with placebo.

    In plain wordsIn IBS-C patients, diarrhea was more frequent with linaclotide than placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseDiarrhea
    Study

    n = 839

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    290 μg once daily · oralAs given in this study (human).

    Measurements

    Diarrhea
    9.4%
    linaclotide
    Diarrhea
    1.2%
    placebo

    Source sentences

    Summary
    Diarrhea was the most common adverse event (9.4% linaclotide, 1.2% placebo).
    1 context sentence
    Summary · context
    This Phase 3, double-blind trial randomized IBS-C patients to once-daily oral 290-μg linaclotide or placebo at centers in China, North America, and Oceania.
  5. 05HumanRandomized controlled trialSafety outcome

    In IBS-C patients, diarrhea discontinuations occurred in 0.7% with linaclotide versus 0.2% with placebo.

    In plain wordsIn IBS-C patients, diarrhea discontinuations were more frequent with linaclotide than placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseDiscontinuation due to diarrhea
    Study

    n = 839

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    290 μg once daily · oralAs given in this study (human).

    Measurements

    Discontinuation due to diarrhea
    0.7%
    linaclotide
    Discontinuation due to diarrhea
    0.2%
    placebo

    Source sentences

    Summary
    Discontinuation rates due to diarrhea were low (0.7% linaclotide, 0.2% placebo).
    1 context sentence
    Summary · context
    This Phase 3, double-blind trial randomized IBS-C patients to once-daily oral 290-μg linaclotide or placebo at centers in China, North America, and Oceania.

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, 16:34 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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