Clinical response to linaclotide at week 4 predicts sustained response in irritable bowel syndrome with constipation and improvements in digestive and extra-digestive symptoms.

Serrano-Falcón B, Delgado-Aros S, Mearin F, Ciriza de Los Ríos C, Serra J, Mínguez M, Montoro Huguet M, Perelló A, Santander C, Pérez Aisa Á, Bañón-Rodríguez I, Rey E

Therapeutic advances in gastroenterology5 Aug 2019Cited by 4 (Europe PMC)

PMID31428193PMCIDPMC6683318DOI10.1177/1756284819857358PepBankPUB-31428193

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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 study11

11 results from studies that gave the peptide. 11 results from people.

01HumanNon-randomized trialEfficacy outcome
In Spanish IBS-C patients receiving linaclotide, the intention-to-treat clinical response rate at week 12 was 25.0%.
In plain wordsIn Spanish IBS-C patients receiving linaclotide, 25.0% responded at week 12 in the intention-to-treat analysis.
Peptide
Linaclotide
Outcome
Not applicableClinical response at week 12, intention-to-treat
Study
n: not reported in source
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
290 μg once daily · 12 weeksAs given in this study (human).
Measurements
Clinical responders at week 12
25%
intention-to-treat population
Source sentences
Summary
In the intention-to-treat and per-protocol populations, 22.9% and 31.7% were clinical responders at week 4, respectively, and 25.0% and 36.7% were clinical responders at week 12.
1 context sentence(design, population, supporting numbers)
Summary · context
In this open-label phase IIIb study, patients with moderate-to-severe IBS-C received linaclotide 290 μg once daily for 12 weeks.
Report a problemFND-3142819303
02HumanNon-randomized trialEfficacy outcome
In Spanish IBS-C patients receiving linaclotide, the per-protocol clinical response rate at week 12 was 36.7%.
In plain wordsIn Spanish IBS-C patients receiving linaclotide, 36.7% responded at week 12 in the per-protocol analysis.
Peptide
Linaclotide
Outcome
Not applicableClinical response at week 12, per-protocol
Study
n: not reported in source
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
290 μg once daily · 12 weeksAs given in this study (human).
Measurements
Clinical responders at week 12
36.7%
per-protocol population
Source sentences
Summary
In the intention-to-treat and per-protocol populations, 22.9% and 31.7% were clinical responders at week 4, respectively, and 25.0% and 36.7% were clinical responders at week 12.
1 context sentence(design, population, supporting numbers)
Summary · context
In this open-label phase IIIb study, patients with moderate-to-severe IBS-C received linaclotide 290 μg once daily for 12 weeks.
Report a problemFND-3142819304
03HumanNon-randomized trialEfficacy outcome
In Spanish IBS-C patients receiving linaclotide, the intention-to-treat clinical response rate at week 4 was 22.9%.
In plain wordsIn Spanish IBS-C patients receiving linaclotide, 22.9% responded at week 4 in the intention-to-treat analysis.
Peptide
Linaclotide
Outcome
Not applicableClinical response at week 4, intention-to-treat
Study
n: not reported in source
Outcome group
Bowel Function · Gastrointestinal
Studied dose
290 μg once dailyAs given in this study (human).
Measurements
Clinical responders at week 4
22.9%
intention-to-treat population
Source sentences
Summary
In the intention-to-treat and per-protocol populations, 22.9% and 31.7% were clinical responders at week 4, respectively, and 25.0% and 36.7% were clinical responders at week 12.
1 context sentence(design, population, supporting numbers)
Summary · context
In this open-label phase IIIb study, patients with moderate-to-severe IBS-C received linaclotide 290 μg once daily for 12 weeks.
Report a problemFND-3142819301
04HumanNon-randomized trialEfficacy outcome
In Spanish IBS-C patients receiving linaclotide, the per-protocol clinical response rate at week 4 was 31.7%.
In plain wordsIn Spanish IBS-C patients receiving linaclotide, 31.7% responded at week 4 in the per-protocol analysis.
Peptide
Linaclotide
Outcome
Not applicableClinical response at week 4, per-protocol
Study
n: not reported in source
Outcome group
Bowel Function · Gastrointestinal
Studied dose
290 μg once dailyAs given in this study (human).
Measurements
Clinical responders at week 4
31.7%
per-protocol population
Source sentences
Summary
In the intention-to-treat and per-protocol populations, 22.9% and 31.7% were clinical responders at week 4, respectively, and 25.0% and 36.7% were clinical responders at week 12.
1 context sentence(design, population, supporting numbers)
Summary · context
In this open-label phase IIIb study, patients with moderate-to-severe IBS-C received linaclotide 290 μg once daily for 12 weeks.
Report a problemFND-3142819302
05HumanNon-randomized trialEfficacy outcome
In Spanish IBS-C patients receiving linaclotide, digestive nonintestinal symptom scores improved significantly at week 4.
In plain wordsIn Spanish IBS-C patients receiving linaclotide, digestive nonintestinal symptoms improved from baseline at week 4.
Peptide
Linaclotide
Outcome
Direction not reportedDigestive nonintestinal symptoms at week 4
Study
n: not reported in source
Comparator
Baseline
Outcome group
Digestive Symptoms · Gastrointestinal
Studied dose
290 μg once dailyAs given in this study (human).
Source sentences
Summary
Digestive nonintestinal and extra-digestive symptom scores were significantly improved at weeks 4 and 12.
1 context sentence(design, population, supporting numbers)
Summary · context
In this open-label phase IIIb study, patients with moderate-to-severe IBS-C received linaclotide 290 μg once daily for 12 weeks.
Report a problemFND-3142819305
06HumanNon-randomized trialEfficacy outcome
In Spanish IBS-C patients receiving linaclotide, digestive nonintestinal symptom scores improved significantly at week 12.
In plain wordsIn Spanish IBS-C patients receiving linaclotide, digestive nonintestinal symptoms improved from baseline at week 12.
Peptide
Linaclotide
Outcome
Direction not reportedDigestive nonintestinal symptoms at week 12
Study
n: not reported in source
Comparator
Baseline
Outcome group
Digestive Symptoms · Gastrointestinal
Studied dose
290 μg once daily · 12 weeksAs given in this study (human).
Source sentences
Summary
Digestive nonintestinal and extra-digestive symptom scores were significantly improved at weeks 4 and 12.
1 context sentence(design, population, supporting numbers)
Summary · context
In this open-label phase IIIb study, patients with moderate-to-severe IBS-C received linaclotide 290 μg once daily for 12 weeks.
Report a problemFND-3142819306
07HumanNon-randomized trialEfficacy outcome
In Spanish IBS-C patients receiving linaclotide, extra-digestive symptom scores improved significantly at week 4.
In plain wordsIn Spanish IBS-C patients receiving linaclotide, extra-digestive symptoms improved from baseline at week 4.
Peptide
Linaclotide
Outcome
Direction not reportedExtra-digestive symptoms at week 4
Study
n: not reported in source
Comparator
Baseline
Outcome group
Extra-Digestive Symptoms · Whole body
Studied dose
290 μg once dailyAs given in this study (human).
Source sentences
Summary
Digestive nonintestinal and extra-digestive symptom scores were significantly improved at weeks 4 and 12.
1 context sentence(design, population, supporting numbers)
Summary · context
In this open-label phase IIIb study, patients with moderate-to-severe IBS-C received linaclotide 290 μg once daily for 12 weeks.
Report a problemFND-3142819307
08HumanNon-randomized trialEfficacy outcome
In Spanish IBS-C patients receiving linaclotide, extra-digestive symptom scores improved significantly at week 12.
In plain wordsIn Spanish IBS-C patients receiving linaclotide, extra-digestive symptoms improved from baseline at week 12.
Peptide
Linaclotide
Outcome
Direction not reportedExtra-digestive symptoms at week 12
Study
n: not reported in source
Comparator
Baseline
Outcome group
Extra-Digestive Symptoms · Whole body
Studied dose
290 μg once daily · 12 weeksAs given in this study (human).
Source sentences
Summary
Digestive nonintestinal and extra-digestive symptom scores were significantly improved at weeks 4 and 12.
1 context sentence(design, population, supporting numbers)
Summary · context
In this open-label phase IIIb study, patients with moderate-to-severe IBS-C received linaclotide 290 μg once daily for 12 weeks.
Report a problemFND-3142819308
09HumanNon-randomized trialSafety outcome
In Spanish IBS-C patients receiving linaclotide, diarrhea including loose or watery stools occurred in 35.4%.
In plain wordsIn Spanish IBS-C patients receiving linaclotide, 35.4% reported diarrhea, including loose or watery stools.
Peptide
Linaclotide
Outcome
Not applicableDiarrhea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
290 μg once daily · 12 weeksAs given in this study (human).
Measurements
Diarrhea incidence
35.4%
linaclotide 290 μg once daily
Source sentences
Summary
The most common adverse event was diarrhea inclusive of loose or watery stools (35.4%).
1 context sentence(design, population, supporting numbers)
Summary · context
In this open-label phase IIIb study, patients with moderate-to-severe IBS-C received linaclotide 290 μg once daily for 12 weeks.
Report a problemFND-3142819311
10HumanObservational studyOther
In linaclotide-treated Spanish IBS-C patients, baseline characteristics were not associated with clinical response at week 12.
In plain wordsIn linaclotide-treated Spanish IBS-C patients, baseline characteristics were not linked to response at week 12.
Peptide
Linaclotide
Outcome
No significant changeBaseline characteristics and week 12 response
Study
n: not reported in source
Outcome group
Overall treatment effect · Gastrointestinal
Studied dose
290 μg once dailyAs given in this study (human).
Source sentences
Summary
Baseline characteristic was not associated with week 12 clinical response; however, clinical response at week 4 was predictive of response at week 12 (OR: 6.5; 95%IC: 2.1-19.8).
1 context sentence(design, population, supporting numbers)
Summary · context
In this open-label phase IIIb study, patients with moderate-to-severe IBS-C received linaclotide 290 μg once daily for 12 weeks.
Report a problemFND-3142819309
11HumanObservational studyOther
In linaclotide-treated Spanish IBS-C patients, week 4 response predicted week 12 response (OR 6.5, 95%IC 2.1-19.8).
In plain wordsIn linaclotide-treated Spanish IBS-C patients, response at week 4 was linked to response at week 12.
Peptide
Linaclotide
Outcome
IncreaseWeek 4 response predicting week 12 response
Study
n: not reported in source
Comparator
Patients without clinical response at week 4
Outcome group
Overall treatment effect · Gastrointestinal
Studied dose
290 μg once dailyAs given in this study (human).
Measurements
Odds ratio, week 4 response predicting week 12 response
6.5 ratio
linaclotide-treated patients
95% confidence interval for odds ratio
2.1 to 19.8 ratio
linaclotide-treated patients
Source sentences
Summary
Baseline characteristic was not associated with week 12 clinical response; however, clinical response at week 4 was predictive of response at week 12 (OR: 6.5; 95%IC: 2.1-19.8).
1 context sentence(design, population, supporting numbers)
Summary · context
In this open-label phase IIIb study, patients with moderate-to-severe IBS-C received linaclotide 290 μg once daily for 12 weeks.
Report a problemFND-3142819310

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.

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

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