Efficacy and safety of linaclotide in treating functional constipation in paediatric patients: a randomised, double-blind, placebo-controlled, multicentre, phase 3 trial.

Di Lorenzo C, Khlevner J, Rodriguez-Araujo G, Xie W, Huh SY, Ando M, Hyams JS, Nurko S, Benninga MA, Simon M, Hewson ME, Saps M

The lancet. Gastroenterology & hepatology8 Jan 2024Cited by 19 (Europe PMC)

PMID38211604DOI10.1016/s2468-1253(23)00398-9PepBankPUB-38211604

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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 study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialEfficacy outcome
In children with functional constipation, linaclotide increased SBM frequency versus placebo by 1·17 per week (95% CI 0·65-1·69, p<0·0001).
In plain wordsLinaclotide increased spontaneous bowel movement frequency more than placebo in children with functional constipation.
Peptide
Linaclotide
Outcome
IncreaseSBM frequency change
Study
n = 328
Comparator
Placebo
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
72 μg once daily · oral · 12 weeksAs given in this study (human).
Measurements
LSM change
2.22 SBMs per week
linaclotide
LSM change SE
0.19 SBMs per week
linaclotide
LSM change
1.05 SBMs per week
placebo
LSM change SE
0.19 SBMs per week
placebo
Difference
1.17 SBMs per week
linaclotide versus placebo
95% CI lower
0.65 SBMs per week
difference
95% CI upper
1.69 SBMs per week
difference
Source sentences
Summary
Compared with placebo (least-squares mean [LSM] CFB 1·05 SBMs per week [SE 0·19]), patients treated with linaclotide showed significant improvement in SBM frequency (LSM CFB 2·22 SBMs per week [0·19]; LSM CFB difference 1·17 SBMs per week [95% CI 0·65-1·69]; p<0·0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 6-17 years who met modified Rome III criteria for functional constipation were randomly assigned (1:1), with a block size of four and stratified by age (6-11 years and 12-17 years), to receive either oral linaclotide 72 μg or placebo once daily for 12 weeks.
Report a problemFND-3821160402
02HumanRandomized controlled trialEfficacy outcome
In children with functional constipation, linaclotide improved stool consistency versus placebo (LSM difference 0·42, 95% CI 0·21-0·64, p=0·0001).
In plain wordsLinaclotide improved stool consistency more than placebo in children with functional constipation.
Peptide
Linaclotide
Outcome
IncreaseStool consistency change
Study
n = 328
Comparator
Placebo
Analysis
Secondary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
72 μg once daily · oral · 12 weeksAs given in this study (human).
Measurements
LSM change
1.11 score
linaclotide
LSM change SE
0.08 score
linaclotide
LSM change
0.69 score
placebo
LSM change SE
0.08 score
placebo
Difference
0.42 score
between groups
95% CI lower
0.21 score
difference
95% CI upper
0.64 score
difference
Source sentences
Summary
Linaclotide also significantly improved stool consistency over placebo (LSM CFB 1·11 [SE 0·08] vs 0·69 [0·08]; LSM CFB difference 0·42 [95% CI 0·21-0·64]; p=0·0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 6-17 years who met modified Rome III criteria for functional constipation were randomly assigned (1:1), with a block size of four and stratified by age (6-11 years and 12-17 years), to receive either oral linaclotide 72 μg or placebo once daily for 12 weeks.
Report a problemFND-3821160403
03HumanRandomized controlled trialSafety outcome
In children with functional constipation, diarrhoea occurred in seven of 164 linaclotide recipients (4%) versus three of 164 placebo recipients (2%).
In plain wordsDiarrhoea occurred in more children receiving linaclotide than placebo.
Peptide
Linaclotide
Outcome
IncreaseTreatment-emergent diarrhoea
Study
n = 328
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
72 μg once daily · oral · 12 weeksAs given in this study (human).
Measurements
Diarrhoea patients
7 patients
linaclotide (of 164)
Diarrhoea incidence
4%
linaclotide
Diarrhoea patients
3 patients
placebo (of 164)
Diarrhoea incidence
2%
placebo
Source sentences
Summary
The most reported treatment-emergent adverse event (TEAE) by patients treated with linaclotide was diarrhoea (seven [4%] of 164 vs three [2%] of 164 patients in the placebo group)
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 6-17 years who met modified Rome III criteria for functional constipation were randomly assigned (1:1), with a block size of four and stratified by age (6-11 years and 12-17 years), to receive either oral linaclotide 72 μg or placebo once daily for 12 weeks.
Report a problemFND-3821160404
04HumanRandomized controlled trialSafety outcome
In children with functional constipation, COVID-19 occurred in four linaclotide recipients (2%) versus five placebo recipients (3%).
In plain wordsCOVID-19 occurred in fewer children receiving linaclotide than placebo.
Peptide
Linaclotide
Outcome
DecreaseCOVID-19
Study
n = 328
Comparator
Placebo
Outcome group
Adverse events · Infection
Studied dose
72 μg once daily · oral · 12 weeksAs given in this study (human).
Measurements
COVID-19 patients
4 patients
linaclotide
COVID-19 incidence
2%
linaclotide
COVID-19 patients
5 patients
placebo
COVID-19 incidence
3%
placebo
Source sentences
Summary
and by patients treated with placebo was COVID-19 (five [3%] vs four [2%] in the linaclotide group).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 6-17 years who met modified Rome III criteria for functional constipation were randomly assigned (1:1), with a block size of four and stratified by age (6-11 years and 12-17 years), to receive either oral linaclotide 72 μg or placebo once daily for 12 weeks.
Report a problemFND-3821160405
05HumanRandomized controlled trialSafety outcome
Treatment-related diarrhoea occurred in six children receiving linaclotide (4%) versus two receiving placebo (1%).
In plain wordsTreatment-related diarrhoea occurred in more children receiving linaclotide than placebo.
Peptide
Linaclotide
Outcome
IncreaseTreatment-related diarrhoea
Study
n = 328
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
72 μg once daily · oral · 12 weeksAs given in this study (human).
Measurements
Treatment-related diarrhoea patients
6 patients
linaclotide
Treatment-related diarrhoea incidence
4%
linaclotide
Treatment-related diarrhoea patients
2 patients
placebo
Treatment-related diarrhoea incidence
1%
placebo
Source sentences
Summary
The most frequent treatment-related TEAE was diarrhoea (linaclotide: six [4%] patients; placebo: two [1%] patients).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 6-17 years who met modified Rome III criteria for functional constipation were randomly assigned (1:1), with a block size of four and stratified by age (6-11 years and 12-17 years), to receive either oral linaclotide 72 μg or placebo once daily for 12 weeks.
Report a problemFND-3821160406
06HumanRandomized controlled trialSafety outcome
No deaths occurred in the paediatric linaclotide versus placebo study.
In plain wordsNo children died in the linaclotide or placebo groups.
Peptide
Linaclotide
Outcome
No significant changeDeaths
Study
n = 328
Comparator
Placebo
Outcome group
Mortality · Whole body
Studied dose
72 μg once daily · oral · 12 weeksAs given in this study (human).
Source sentences
Summary
No deaths occurred during the study.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 6-17 years who met modified Rome III criteria for functional constipation were randomly assigned (1:1), with a block size of four and stratified by age (6-11 years and 12-17 years), to receive either oral linaclotide 72 μg or placebo once daily for 12 weeks.
Report a problemFND-3821160408
07HumanNon-randomized trialEfficacy outcome
In children with functional constipation, linaclotide-arm mean SBM frequency increased from 1·16 to 3·41 per week during intervention.
In plain wordsChildren receiving linaclotide had more spontaneous bowel movements during treatment than at baseline.
Peptide
Linaclotide
Outcome
IncreaseSBM frequency during intervention
Study
n = 164
Comparator
Baseline
Outcome group
Bowel Function · Gastrointestinal
Studied dose
72 μg once daily · oral · 12 weeksAs given in this study (human).
Measurements
Baseline SBM frequency
1.16 SBMs per week
linaclotide
Baseline SBM frequency SD
0.83 SBMs per week
linaclotide
Intervention SBM frequency
3.41 SBMs per week
linaclotide
Intervention SBM frequency SD
2.76 SBMs per week
linaclotide
Source sentences
Summary
At baseline, the mean frequency rate for SBMs was 1·28 SBMs per week (SD 0·87) for placebo and 1·16 SBMs per week (0·83) for linaclotide, increasing to 2·29 SBMs per week (1·99) for placebo and 3·41 SBMs per week (2·76) for linaclotide during intervention.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 6-17 years who met modified Rome III criteria for functional constipation were randomly assigned (1:1), with a block size of four and stratified by age (6-11 years and 12-17 years), to receive either oral linaclotide 72 μg or placebo once daily for 12 weeks.
Report a problemFND-3821160401
08HumanNon-randomized trialSafety outcome
One linaclotide-treated child had treatment-related severe diarrhoea with dehydration and hospitalisation, which resolved after intravenous fluids without sequelae.
In plain wordsOne child receiving linaclotide had severe diarrhoea, dehydration, and hospitalisation, then recovered after intravenous fluids.
Peptide
Linaclotide
Outcome
Not applicableSerious severe diarrhoea with dehydration and hospitalisation
Study
n = 164
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
72 μg once daily · oral · 12 weeksAs given in this study (human).
Measurements
Serious treatment-related diarrhoea cases
1 patients
linaclotide
Source sentences
Summary
One serious adverse event of special interest (treatment-related severe diarrhoea resulting in dehydration and hospitalisation) occurred in a female patient aged 17 years in the linaclotide group; this case resolved without sequelae after administration of intravenous fluids.
1 context sentence(design, population, supporting numbers)
Summary · context
Patients aged 6-17 years who met modified Rome III criteria for functional constipation were randomly assigned (1:1), with a block size of four and stratified by age (6-11 years and 12-17 years), to receive either oral linaclotide 72 μg or placebo once daily for 12 weeks.
Report a problemFND-3821160407

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 postedNCT04026113

Linaclotide Safety and Efficacy in Pediatric Participants, 6 to 17 Years of Age, With Irritable Bowel Syndrome With Constipation (IBS-C) or Functional Constipation (FC)

AbbVien = 4381 Oct 2019 to 29 May 2024

Functional Constipation · Irritable Bowel Syndrome With Constipation

Trial page ClinicalTrials.govUpdated 26 Nov 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.

Version 2Current
28 Oct 2026, 02:03 UTC
Study results updated
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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MeSH terms

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