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Study · Randomized controlled trial · 2024

5 results

Safety and efficacy of linaclotide in children aged 2-5 years with functional constipation: Phase 2, randomized study.

Di Lorenzo C, Robert J, Rodriguez-Araujo G, Shakhnovich V, Xie W, Nurko S, Saps M

Journal of pediatric gastroenterology and nutrition4 Jul 2024Cited by 5 (Europe PMC)

PMID38962910 (opens in a new tab)DOI10.1002/jpn3.12306 (opens in a new tab)PepBankPUB-38962910
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 children with functional constipation, linaclotide 72 μg showed greater improvement than placebo in three of four unspecified key efficacy endpoints.

    In plain wordsLinaclotide improved three of four key measures more than placebo, but the abstract does not identify those measures.

    Peptide
    Linaclotide
    Outcome
    MixedThree of four key efficacy endpoints
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    72 μg · 4 weeksAs given in this study (human).

    Source sentences

    Summary
    Mean change from baseline over the treatment period for three of the four key efficacy endpoints showed greater improvement in the linaclotide 72 μg group versus placebo.
    1 context sentence
    Summary · context
    This study evaluated the dose-response, safety, and efficacy of 4 weeks of linaclotide compared with placebo in children 2-5 years of age with FC.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In children with functional constipation receiving linaclotide, stool consistency showed a dose-response trend without a stated direction.

    In plain wordsStool consistency showed a dose-response trend during linaclotide treatment in children.

    Peptide
    Linaclotide
    Outcome
    Direction not reportedStool consistency dose-response
    Study

    n: not reported in source

    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    Dose not stated · 4 weeksAs given in this study (human).

    Source sentences

    Summary
    A dose-response trend was seen for stool consistency in patients receiving linaclotide.
    1 context sentence
    Summary · context
    This study evaluated the dose-response, safety, and efficacy of 4 weeks of linaclotide compared with placebo in children 2-5 years of age with FC.
  3. 03HumanNon-randomized trialSafety outcome

    Four children randomized to linaclotide experienced treatment-emergent adverse events.

    In plain wordsFour children assigned to linaclotide experienced adverse events during treatment.

    Peptide
    Linaclotide
    Outcome
    Not applicableTreatment-emergent adverse events
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · 4 weeksAs given in this study (human).

    Measurements

    Patients with treatment-emergent adverse events
    4 patients
    randomized to linaclotide

    Source sentences

    Summary
    Four patients randomized to linaclotide experienced treatment-emergent AEs, one of which was treatment-related (mild diarrhea).
    1 context sentence
    Summary · context
    This study evaluated the dose-response, safety, and efficacy of 4 weeks of linaclotide compared with placebo in children 2-5 years of age with FC.
  4. 04HumanNon-randomized trialSafety outcome

    One child randomized to linaclotide experienced treatment-related mild diarrhea.

    In plain wordsOne child assigned to linaclotide experienced mild diarrhea related to treatment.

    Peptide
    Linaclotide
    Outcome
    Not applicableTreatment-related mild diarrhea
    Study

    n: not reported in source

    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    Dose not stated · 4 weeksAs given in this study (human).

    Measurements

    Patients with treatment-related mild diarrhea
    1 patients
    randomized to linaclotide

    Source sentences

    Summary
    Four patients randomized to linaclotide experienced treatment-emergent AEs, one of which was treatment-related (mild diarrhea).
    1 context sentence
    Summary · context
    This study evaluated the dose-response, safety, and efficacy of 4 weeks of linaclotide compared with placebo in children 2-5 years of age with FC.
  5. 05HumanNon-randomized trialSafety outcome

    In the pediatric linaclotide study, all adverse events were mild or moderate and none were severe.

    In plain wordsAll adverse events in the pediatric linaclotide study were mild or moderate.

    Peptide
    Linaclotide
    Outcome
    Not applicableAdverse event severity
    Study

    n: not reported in source

    Outcome group
    Adverse events · Whole body
    Studied dose
    Dose not stated · 4 weeksAs given in this study (human).

    Source sentences

    Summary
    All AEs were mild or moderate and none were severe.
    1 context sentence
    Summary · context
    This study evaluated the dose-response, safety, and efficacy of 4 weeks of linaclotide compared with placebo in children 2-5 years of age with FC.

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 2Results postedNCT04110145

Linaclotide Safety and Efficacy in 2 to 5-Year-Old Participants With Functional Constipation

Allergann = 3514 Oct 2019 to 20 Apr 2021

Functional Constipation

Trial pageClinicalTrials.govUpdated 26 Apr 2022

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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