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Study · Randomized controlled trial · n = 500 · 2018

7 results

A randomized controlled and long-term linaclotide study of irritable bowel syndrome with constipation patients in Japan.

Fukudo S, Miwa H, Nakajima A, Haruma K, Kosako M, Nakagawa A, Akiho H, Yamaguchi Y, Johnston JM, Currie M, Kinoshita Y

Neurogastroenterology and motility22 Aug 2018Cited by 27 (Europe PMC)

PMID30136447 (opens in a new tab)DOI10.1111/nmo.13444 (opens in a new tab)PepBankPUB-30136447
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: CC BY-NC. 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 Japanese patients with IBS-C, linaclotide increased global improvement responder rates versus placebo (P < 0.001).

    In plain wordsIn Japanese patients with IBS-C, linaclotide increased global improvement responder rates versus placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseGlobal IBS improvement response
    Study

    n = 500

    Comparator
    placebo
    Analysis
    Primary
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    0.5 mg daily · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Part 1: The responder rates for global improvement and for CSBM frequency were significantly higher for linaclotide compared to placebo (P < 0.001).
    3 context sentences
    Summary · context
    This was a randomized, double-blind, placebo-controlled (Part 1) and long-term, open-label extension (Part 2) study of linaclotide at 60 hospitals and clinics in Japan.
    Summary · context
    Patients with IBS-C diagnosed using Rome III criteria (n = 500) were randomly assigned to linaclotide 0.5 mg (n = 249) or placebo (n = 251) for a 12-week treatment period followed by open-label treatment with linaclotide (n = 324) for an additional 40 weeks.
    Summary · context
    The primary endpoints were the responder rate of global improvement of IBS symptoms and complete spontaneous bowel movement (CSBM) during 12 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with IBS-C, linaclotide increased CSBM frequency responder rates versus placebo (P < 0.001).

    In plain wordsIn Japanese patients with IBS-C, linaclotide increased complete spontaneous bowel movement responder rates versus placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseCSBM frequency response
    Study

    n = 500

    Comparator
    placebo
    Analysis
    Primary
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    0.5 mg daily · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Part 1: The responder rates for global improvement and for CSBM frequency were significantly higher for linaclotide compared to placebo (P < 0.001).
    3 context sentences
    Summary · context
    This was a randomized, double-blind, placebo-controlled (Part 1) and long-term, open-label extension (Part 2) study of linaclotide at 60 hospitals and clinics in Japan.
    Summary · context
    Patients with IBS-C diagnosed using Rome III criteria (n = 500) were randomly assigned to linaclotide 0.5 mg (n = 249) or placebo (n = 251) for a 12-week treatment period followed by open-label treatment with linaclotide (n = 324) for an additional 40 weeks.
    Summary · context
    The primary endpoints were the responder rate of global improvement of IBS symptoms and complete spontaneous bowel movement (CSBM) during 12 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with IBS-C, linaclotide increased SBM responder rates versus placebo.

    In plain wordsIn Japanese patients with IBS-C, linaclotide increased spontaneous bowel movement responder rates versus placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseSBM response
    Study

    n = 500

    Comparator
    placebo
    Analysis
    Secondary
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    0.5 mg daily · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Secondary endpoints including responder rates for SBM and abdominal pain/discomfort relief in the linaclotide group were also significantly greater than those in the placebo group.
    2 context sentences
    Summary · context
    This was a randomized, double-blind, placebo-controlled (Part 1) and long-term, open-label extension (Part 2) study of linaclotide at 60 hospitals and clinics in Japan.
    Summary · context
    Patients with IBS-C diagnosed using Rome III criteria (n = 500) were randomly assigned to linaclotide 0.5 mg (n = 249) or placebo (n = 251) for a 12-week treatment period followed by open-label treatment with linaclotide (n = 324) for an additional 40 weeks.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In Japanese patients with IBS-C, linaclotide increased abdominal pain/discomfort relief responder rates versus placebo.

    In plain wordsIn Japanese patients with IBS-C, linaclotide increased pain and discomfort relief responder rates versus placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseAbdominal pain/discomfort relief response
    Study

    n = 500

    Comparator
    placebo
    Analysis
    Secondary
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    0.5 mg daily · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Secondary endpoints including responder rates for SBM and abdominal pain/discomfort relief in the linaclotide group were also significantly greater than those in the placebo group.
    2 context sentences
    Summary · context
    This was a randomized, double-blind, placebo-controlled (Part 1) and long-term, open-label extension (Part 2) study of linaclotide at 60 hospitals and clinics in Japan.
    Summary · context
    Patients with IBS-C diagnosed using Rome III criteria (n = 500) were randomly assigned to linaclotide 0.5 mg (n = 249) or placebo (n = 251) for a 12-week treatment period followed by open-label treatment with linaclotide (n = 324) for an additional 40 weeks.
  5. 05HumanNon-randomized trialEfficacy outcome

    In the IBS-C extension, patients switched from placebo to linaclotide had similar global improvement responder rates to continued linaclotide recipients.

    In plain wordsIn patients with IBS-C, global improvement response was similar after switching to linaclotide and continuing linaclotide.

    Peptide
    Linaclotide
    Outcome
    No significant changeExtension global improvement response
    Study

    n = 324

    Comparator
    continued linaclotide
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    0.5 mg daily · 40 additional weeksAs given in this study (human).

    Source sentences

    Summary
    Part 2: Patients switched from placebo to linaclotide showed similar responder rates for global improvement and CSBM frequency to those in patients who continued to receive linaclotide, supporting sustained efficacy.
    2 context sentences
    Summary · context
    This was a randomized, double-blind, placebo-controlled (Part 1) and long-term, open-label extension (Part 2) study of linaclotide at 60 hospitals and clinics in Japan.
    Summary · context
    Patients with IBS-C diagnosed using Rome III criteria (n = 500) were randomly assigned to linaclotide 0.5 mg (n = 249) or placebo (n = 251) for a 12-week treatment period followed by open-label treatment with linaclotide (n = 324) for an additional 40 weeks.
  6. 06HumanNon-randomized trialEfficacy outcome

    In the IBS-C extension, patients switched from placebo to linaclotide had similar CSBM frequency responder rates to continued linaclotide recipients.

    In plain wordsIn patients with IBS-C, bowel movement response was similar after switching to linaclotide and continuing linaclotide.

    Peptide
    Linaclotide
    Outcome
    No significant changeExtension CSBM frequency response
    Study

    n = 324

    Comparator
    continued linaclotide
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    0.5 mg daily · 40 additional weeksAs given in this study (human).

    Source sentences

    Summary
    Part 2: Patients switched from placebo to linaclotide showed similar responder rates for global improvement and CSBM frequency to those in patients who continued to receive linaclotide, supporting sustained efficacy.
    2 context sentences
    Summary · context
    This was a randomized, double-blind, placebo-controlled (Part 1) and long-term, open-label extension (Part 2) study of linaclotide at 60 hospitals and clinics in Japan.
    Summary · context
    Patients with IBS-C diagnosed using Rome III criteria (n = 500) were randomly assigned to linaclotide 0.5 mg (n = 249) or placebo (n = 251) for a 12-week treatment period followed by open-label treatment with linaclotide (n = 324) for an additional 40 weeks.
  7. 07HumanNon-randomized trialSafety outcome

    In the Japanese IBS-C study, diarrhea occurred in 14.5% of patients, with all cases mild or moderate.

    In plain wordsIn the Japanese IBS-C study, diarrhea occurred in 14.5% of patients and was mild or moderate.

    Peptide
    Linaclotide
    Outcome
    Not applicableDiarrhea
    Study

    n: not reported in source

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

    Measurements

    Diarrhea
    14.5%
    reported patients

    Source sentences

    Summary
    Diarrhea was seen in 14.5% of patients; all cases were mild or moderate.
    2 context sentences
    Summary · context
    This was a randomized, double-blind, placebo-controlled (Part 1) and long-term, open-label extension (Part 2) study of linaclotide at 60 hospitals and clinics in Japan.
    Summary · context
    Patients with IBS-C diagnosed using Rome III criteria (n = 500) were randomly assigned to linaclotide 0.5 mg (n = 249) or placebo (n = 251) for a 12-week treatment period followed by open-label treatment with linaclotide (n = 324) for an additional 40 weeks.

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

Registered trials1

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

1 trial · 1 completed · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3NCT02316899

Phase III Study to Evaluate the Efficacy and Safety of ASP0456 in Patients With Constipation Predominant Irritable Bowel Syndrome

Astellas Pharma Incn = 50021 Oct 2014 to 29 Mar 2016

Irritable Bowel Syndrome With Constipation (IBS-C)

Trial pageClinicalTrials.govUpdated 18 Oct 2024

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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