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Study · Non-randomized trial · n = 1,178 · 2023

5 results

Linaclotide Reduced Response Time for Irritable Bowel Syndrome With Constipation Symptoms: Analysis of 4 Randomized Controlled Trials.

Brenner DM, Lacy BE, Ford AC, Bartolini W, Wu J, Shea EP, Bochenek W, Boinpally R, Almansa C

The American journal of gastroenterology12 Oct 2022Cited by 16 (Europe PMC)

PMID36227782 (opens in a new tab)PMCIDPMC10144280 (opens in a new tab)DOI10.14309/ajg.0000000000002064 (opens in a new tab)PepBankPUB-36227782
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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-ND. Results still quote short attributed sentences.

Results from this study5

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

  1. 01HumanNon-randomized trialEfficacy outcome

    In linaclotide-treated IBS-C patients, more than 50% had at least 30% reduction in abdominal pain, discomfort, or bloating within a median 3-4 weeks.

    In plain wordsMore than half of linaclotide-treated patients had reduced abdominal symptoms within a median three to four weeks.

    Peptide
    Linaclotide
    Outcome
    DecreaseAbdominal symptom response time
    Study

    n = 1,178

    Outcome group
    Gastrointestinal Symptoms · Gastrointestinal
    Studied dose
    290 μgAs given in this study (human).

    Measurements

    Patients with at least 30% decrease in abdominal pain, discomfort, or bloating
    > 50%
    Linaclotide 290 μg, IBS-C
    Median time to at least 30% decrease
    3 to 4 weeks
    Linaclotide 290 μg, IBS-C

    Source sentences

    Summary
    Among 2,350 patients (1,172 placebo and 1,178 linaclotide 290 μg), >50% of patients with IBS-C who initiated linaclotide treatment experienced a decrease of ≥30% in abdominal pain, discomfort, or bloating within 3-4 weeks (median).
    1 context sentence
    Summary · context
    Time-to-response data were pooled from 4 randomized controlled trials.
  2. 02HumanNon-randomized trialEfficacy outcome

    In linaclotide-treated IBS-C patients, median time to achieving at least three CSBMs was 4 weeks.

    In plain wordsLinaclotide-treated patients reached at least three complete spontaneous bowel movements after a median four weeks.

    Peptide
    Linaclotide
    Outcome
    Not applicableTime to at least three CSBMs
    Study

    n = 1,178

    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    290 μgAs given in this study (human).

    Measurements

    Median time to achieving at least 3 CSBMs
    4 weeks
    Linaclotide 290 μg, IBS-C

    Source sentences

    Summary
    The median time to achieving ≥3 CSBMs was 4 weeks.
    2 context sentences
    Summary · context
    Among 2,350 patients (1,172 placebo and 1,178 linaclotide 290 μg), >50% of patients with IBS-C who initiated linaclotide treatment experienced a decrease of ≥30% in abdominal pain, discomfort, or bloating within 3-4 weeks (median).
    Summary · context
    Time-to-response data were pooled from 4 randomized controlled trials.
  3. 03HumanNon-randomized trialEfficacy outcome

    Among linaclotide-treated IBS-C patients, abdominal pain response occurred between 4 and 12 weeks in 1 in 6 patients.

    In plain wordsOne in six linaclotide-treated patients had a late abdominal pain response between four and twelve weeks.

    Peptide
    Linaclotide
    Outcome
    DecreaseLate abdominal pain response
    Study

    n = 1,178

    Outcome group
    Gastrointestinal Symptoms · Gastrointestinal
    Studied dose
    290 μgAs given in this study (human).

    Measurements

    Late abdominal pain response between 4 and 12 weeks
    1 per 6 patients
    Linaclotide 290 μg, IBS-C

    Source sentences

    Summary
    Although not all linaclotide-treated patients responded within 12 weeks, a late response occurred between 4 and 12 weeks in 1 in 6 patients for abdominal pain and in approximately 1 in 10 patients for CSBM frequency.
    1 context sentence
    Summary · context
    Time-to-response data were pooled from 4 randomized controlled trials.
  4. 04HumanNon-randomized trialEfficacy outcome

    Among linaclotide-treated IBS-C patients, CSBM frequency response occurred between 4 and 12 weeks in approximately 1 in 10 patients.

    In plain wordsAbout one in ten linaclotide-treated patients had a late bowel movement response between four and twelve weeks.

    Peptide
    Linaclotide
    Outcome
    IncreaseLate CSBM frequency response
    Study

    n = 1,178

    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    290 μgAs given in this study (human).

    Measurements

    Late CSBM frequency response between 4 and 12 weeks
    ≈ 1 per 10 patients
    Linaclotide 290 μg, IBS-C

    Source sentences

    Summary
    Although not all linaclotide-treated patients responded within 12 weeks, a late response occurred between 4 and 12 weeks in 1 in 6 patients for abdominal pain and in approximately 1 in 10 patients for CSBM frequency.
    1 context sentence
    Summary · context
    Time-to-response data were pooled from 4 randomized controlled trials.
  5. 05HumanObservational studyOther

    In pooled linaclotide time-to-response data in IBS-C, women, Whites, and patients with less severe baseline abdominal symptoms were more likely to respond early.

    In plain wordsIn pooled linaclotide trial data, women, White patients, and patients with milder baseline symptoms were linked to earlier response.

    Peptide
    Linaclotide
    Outcome
    Not applicableEarly response associations
    Study

    n: not reported in source

    Comparator
    Other sex, race, and baseline symptom categories
    Outcome group
    Gastrointestinal Symptoms · Gastrointestinal
    Studied dose
    290 μgAs given in this study (human).

    Source sentences

    Summary
    Comparisons of early responders, late responders, and nonresponders for both response definitions indicated that women, Whites, and patients with less severe baseline abdominal symptoms were more likely to respond early.
    1 context sentence
    Summary · context
    Time-to-response data were pooled from 4 randomized controlled trials.

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 · 1 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT03573908

A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Ironwood Pharmaceuticals, Inc.n = 61420 Jun 2018 to 10 Apr 2019

Irritable Bowel Syndrome Characterized by Constipation

Trial pageClinicalTrials.govUpdated 1 Dec 2020

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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