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Study · Randomized controlled trial · 2019

9 results

Safety and tolerability of linaclotide for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation: pooled Phase 3 analysis.

Nee JW, Johnston JM, Shea EP, Walls CE, Tripp K, Shiff S, Fox SM, Bochenek W, Weissman D, Currie MG, Lembo AJ

Expert review of gastroenterology & hepatology18 Feb 2019Cited by 16 (Europe PMC)

PMID30791771 (opens in a new tab)DOI10.1080/17474124.2019.1575203 (opens in a new tab)PepBankPUB-30791771
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-ND. Results still quote short attributed sentences.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    In pooled RCT patients, diarrhea event rates were 1.1 per patient-year with linaclotide versus 0.2 with placebo.

    In plain wordsIn pooled trials, diarrhea occurred more often with linaclotide than placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseDiarrhea event rate
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    72 µg, 145 µg or 290 µg daily · 12-26 weeksAs given in this study (human).

    Measurements

    Diarrhea TEAE rate
    1.1 per patient-year
    linaclotide, RCTs
    Diarrhea TEAE rate
    0.2 per patient-year
    placebo, RCTs

    Source sentences

    Summary
    Linaclotide patients experienced 1.1 diarrhea TEAE per patient-year in the RCTs (0.2 in placebo), and 0.3 in the LTS studies.
    1 context sentence
    Summary · context
    In six randomized controlled trials (RCTs), patients received linaclotide (72 µg, 145 µg, 290 µg) or placebo daily for 12-26 weeks; in two long-term safety (LTS) studies, patients received open-label linaclotide for ≤78 additional weeks.
  2. 02HumanRandomized controlled trialSafety outcome

    In pooled RCT patients, adverse-event discontinuations occurred in 6.9% with linaclotide versus 3.0% with placebo.

    In plain wordsIn pooled trials, adverse-event discontinuations were more frequent with linaclotide than placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseDiscontinuation due to any adverse event
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    72 µg, 145 µg or 290 µg daily · 12-26 weeksAs given in this study (human).

    Measurements

    Discontinuation due to any adverse event
    6.9%
    linaclotide, RCTs
    Discontinuation due to any adverse event
    3%
    placebo, RCTs

    Source sentences

    Summary
    In RCTs, 6.9% linaclotide and 3.0% placebo patients discontinued due to any adverse event (AE); 4.0% linaclotide and 0.3% placebo patients discontinued due to diarrhea.
    1 context sentence
    Summary · context
    In six randomized controlled trials (RCTs), patients received linaclotide (72 µg, 145 µg, 290 µg) or placebo daily for 12-26 weeks; in two long-term safety (LTS) studies, patients received open-label linaclotide for ≤78 additional weeks.
  3. 03HumanRandomized controlled trialSafety outcome

    In pooled RCT patients, diarrhea discontinuations occurred in 4.0% with linaclotide versus 0.3% with placebo.

    In plain wordsIn pooled trials, diarrhea discontinuations were more frequent with linaclotide than placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseDiscontinuation due to diarrhea
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    72 µg, 145 µg or 290 µg daily · 12-26 weeksAs given in this study (human).

    Measurements

    Discontinuation due to diarrhea
    4%
    linaclotide, RCTs
    Discontinuation due to diarrhea
    0.3%
    placebo, RCTs

    Source sentences

    Summary
    In RCTs, 6.9% linaclotide and 3.0% placebo patients discontinued due to any adverse event (AE); 4.0% linaclotide and 0.3% placebo patients discontinued due to diarrhea.
    1 context sentence
    Summary · context
    In six randomized controlled trials (RCTs), patients received linaclotide (72 µg, 145 µg, 290 µg) or placebo daily for 12-26 weeks; in two long-term safety (LTS) studies, patients received open-label linaclotide for ≤78 additional weeks.
  4. 04HumanRandomized controlled trialSafety outcome

    In pooled trials, serious adverse events were rare and similar between linaclotide and placebo groups.

    In plain wordsIn pooled trials, serious adverse events were rare and similar with linaclotide and placebo.

    Peptide
    Linaclotide
    Outcome
    Direction not reportedSerious adverse events
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Serious AEs (SAEs) were rare and similar across treatment groups; there were no SAEs of diarrhea.
    1 context sentence
    Summary · context
    In six randomized controlled trials (RCTs), patients received linaclotide (72 µg, 145 µg, 290 µg) or placebo daily for 12-26 weeks; in two long-term safety (LTS) studies, patients received open-label linaclotide for ≤78 additional weeks.
  5. 05HumanNon-randomized trialSafety outcome

    In pooled linaclotide RCT patients, 90.5% of diarrhea events were mild or moderate.

    In plain wordsIn pooled trials, most diarrhea events during linaclotide treatment were mild or moderate.

    Peptide
    Linaclotide
    Outcome
    Not applicableDiarrhea severity
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    72 µg, 145 µg or 290 µg daily · 12-26 weeksAs given in this study (human).

    Measurements

    Share of diarrhea TEAEs that were mild or moderate
    90.5%
    pooled RCTs

    Source sentences

    Summary
    The most common TEAE was diarrhea (majority [90.5% in RCTs] mild/moderate).
    1 context sentence
    Summary · context
    In six randomized controlled trials (RCTs), patients received linaclotide (72 µg, 145 µg, 290 µg) or placebo daily for 12-26 weeks; in two long-term safety (LTS) studies, patients received open-label linaclotide for ≤78 additional weeks.
  6. 06HumanNon-randomized trialSafety outcome

    In long-term safety patients, linaclotide diarrhea event rates were 0.3 per patient-year.

    In plain wordsIn long-term safety studies, linaclotide patients experienced 0.3 diarrhea events per patient-year.

    Peptide
    Linaclotide
    Outcome
    Not applicableLong-term diarrhea event rate
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · up to 78 additional weeksAs given in this study (human).

    Measurements

    Diarrhea TEAE rate
    0.3 per patient-year
    linaclotide, long-term safety studies

    Source sentences

    Summary
    Linaclotide patients experienced 1.1 diarrhea TEAE per patient-year in the RCTs (0.2 in placebo), and 0.3 in the LTS studies.
    1 context sentence
    Summary · context
    In six randomized controlled trials (RCTs), patients received linaclotide (72 µg, 145 µg, 290 µg) or placebo daily for 12-26 weeks; in two long-term safety (LTS) studies, patients received open-label linaclotide for ≤78 additional weeks.
  7. 07HumanNon-randomized trialSafety outcome

    In long-term linaclotide safety studies, 9.4% of patients discontinued due to an adverse event.

    In plain wordsIn long-term linaclotide studies, 9.4% of patients stopped treatment because of an adverse event.

    Peptide
    Linaclotide
    Outcome
    Not applicableLong-term discontinuation due to any adverse event
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · up to 78 additional weeksAs given in this study (human).

    Measurements

    Discontinuation due to any adverse event
    9.4%
    linaclotide, long-term safety studies

    Source sentences

    Summary
    In LTS studies, 9.4% patients discontinued due to any AE, and 3.8% due to diarrhea.
    1 context sentence
    Summary · context
    In six randomized controlled trials (RCTs), patients received linaclotide (72 µg, 145 µg, 290 µg) or placebo daily for 12-26 weeks; in two long-term safety (LTS) studies, patients received open-label linaclotide for ≤78 additional weeks.
  8. 08HumanNon-randomized trialSafety outcome

    In long-term linaclotide safety studies, 3.8% of patients discontinued due to diarrhea.

    In plain wordsIn long-term linaclotide studies, 3.8% of patients stopped treatment because of diarrhea.

    Peptide
    Linaclotide
    Outcome
    Not applicableLong-term discontinuation due to diarrhea
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · up to 78 additional weeksAs given in this study (human).

    Measurements

    Discontinuation due to diarrhea
    3.8%
    linaclotide, long-term safety studies

    Source sentences

    Summary
    In LTS studies, 9.4% patients discontinued due to any AE, and 3.8% due to diarrhea.
    1 context sentence
    Summary · context
    In six randomized controlled trials (RCTs), patients received linaclotide (72 µg, 145 µg, 290 µg) or placebo daily for 12-26 weeks; in two long-term safety (LTS) studies, patients received open-label linaclotide for ≤78 additional weeks.
  9. 09HumanNon-randomized trialSafety outcome

    In the pooled linaclotide safety analysis, no serious diarrhea adverse events occurred.

    In plain wordsThe pooled linaclotide safety analysis reported no serious diarrhea adverse events.

    Peptide
    Linaclotide
    Outcome
    Not applicableSerious diarrhea events
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated

    Source sentences

    Summary
    Serious AEs (SAEs) were rare and similar across treatment groups; there were no SAEs of diarrhea.
    1 context sentence
    Summary · context
    In six randomized controlled trials (RCTs), patients received linaclotide (72 µg, 145 µg, 290 µg) or placebo daily for 12-26 weeks; in two long-term safety (LTS) studies, patients received open-label linaclotide for ≤78 additional 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, 16:34 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

Publication types

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