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Study · Randomized controlled trial · n = 186 · 2019

4 results

High-dose linaclotide is effective and safe in patients with chronic constipation: A phase III randomized, double-blind, placebo-controlled study with a long-term open-label extension study in Japan.

Fukudo S, Miwa H, Nakajima A, Kinoshita Y, Kosako M, Hayashi K, Akiho H, Kuroishi K, Johnston JM, Currie M, Ohkusa T

Neurogastroenterology and motility23 Oct 2018Cited by 34 (Europe PMC)

PMID30353619 (opens in a new tab)PMCIDPMC7379198 (opens in a new tab)DOI10.1111/nmo.13487 (opens in a new tab)PepBankPUB-30353619
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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: CC BY-NC. Results still quote short attributed sentences.

Results from this study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In Japanese constipation patients, first-week weekly SBM frequency increased by 4.02 with linaclotide versus 1.48 with placebo (P < 0.001).

    In plain wordsIn Japanese constipation patients, linaclotide increased bowel movement frequency more than placebo during the first week.

    Peptide
    Linaclotide
    Outcome
    IncreaseWeekly SBM frequency at first week
    Study

    n = 186

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    0.5 mgAs given in this study (human).

    Measurements

    Change in weekly mean SBM frequency, first week
    4.02 SBMs/week
    linaclotide 0.5 mg
    Change in weekly mean SBM frequency, first week
    1.48 SBMs/week
    placebo

    Source sentences

    Summary
    Part 1: Change in weekly mean SBM frequency in the first week of treatment with linaclotide (4.02) was significantly greater than that with placebo (1.48, P < 0.001).
    1 context sentence
    Summary · context
    CC patients (n = 186) diagnosed using the Rome III criteria were randomly assigned to linaclotide 0.5 mg (n = 95) or placebo (n = 91) for a 4-week double-blind treatment period in part 1, followed by an additional 52 weeks of open-label treatment with linaclotide in part 2.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Japanese constipation patients, CSBM response was 52.7% with linaclotide versus 26.1% with placebo (P < 0.001).

    In plain wordsIn Japanese constipation patients, complete bowel movement response was higher with linaclotide than placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseCSBM responder rate
    Study

    n = 186

    Comparator
    Placebo
    Analysis
    Secondary
    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    0.5 mg · 4 weeksAs given in this study (human).

    Measurements

    CSBM responder rate
    52.7%
    linaclotide 0.5 mg
    CSBM responder rate
    26.1%
    placebo

    Source sentences

    Summary
    Linaclotide produced a higher CSBM responder rate (52.7%) compared to placebo (26.1%, P < 0.001).
    1 context sentence
    Summary · context
    CC patients (n = 186) diagnosed using the Rome III criteria were randomly assigned to linaclotide 0.5 mg (n = 95) or placebo (n = 91) for a 4-week double-blind treatment period in part 1, followed by an additional 52 weeks of open-label treatment with linaclotide in part 2.
  3. 03HumanNon-randomized trialEfficacy outcome

    In Japanese constipation patients, SBM frequency remained improved during open-label linaclotide treatment.

    In plain wordsIn Japanese constipation patients, bowel movement frequency remained improved during open-label linaclotide treatment.

    Peptide
    Linaclotide
    Outcome
    IncreaseSBM frequency during extension
    Study

    n: not reported in source

    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    0.5 mg · 52 additional weeksAs given in this study (human).

    Source sentences

    Summary
    Part 2: Patients continued to show improved SBM frequency with linaclotide.
    1 context sentence
    Summary · context
    CC patients (n = 186) diagnosed using the Rome III criteria were randomly assigned to linaclotide 0.5 mg (n = 95) or placebo (n = 91) for a 4-week double-blind treatment period in part 1, followed by an additional 52 weeks of open-label treatment with linaclotide in part 2.
  4. 04HumanNon-randomized trialSafety outcome

    In Japanese constipation patients, mild and occasionally moderate diarrhea was the most common drug-related event across both linaclotide study parts.

    In plain wordsIn Japanese constipation patients, diarrhea was the most common drug-related event during linaclotide treatment.

    Peptide
    Linaclotide
    Outcome
    Not applicableDrug-related diarrhea
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    0.5 mgAs given in this study (human).

    Source sentences

    Summary
    Through parts 1 and 2, the most common drug-related adverse event was mild and occasionally moderate diarrhea.
    1 context sentence
    Summary · context
    CC patients (n = 186) diagnosed using the Rome III criteria were randomly assigned to linaclotide 0.5 mg (n = 95) or placebo (n = 91) for a 4-week double-blind treatment period in part 1, followed by an additional 52 weeks of open-label treatment with linaclotide in part 2.

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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