Efficacy and safety of linaclotide in patients with irritable bowel syndrome with constipation: Chinese sub-cohort analysis of a phase III, randomized, double-blind, placebo-controlled trial.

Peng LH, Fang JY, Dai N, Shen XZ, Yang YL, Sun J, Yang YS

Journal of digestive diseases1 Feb 2022Cited by 9 (Europe PMC)

PMID35019221PMCIDPMC9314117DOI10.1111/1751-2980.13081PepBankPUB-35019221

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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.

01HumanRandomized controlled trialEfficacy outcome
In Chinese IBS-C patients, pain/discomfort response occurred in 62.1% with linaclotide versus 53.3% with placebo (OR 1.43, 95% CI 1.05-1.96, P = 0.023).
In plain wordsIn Chinese IBS-C patients, linaclotide increased pain or discomfort response compared with placebo.
Peptide
Linaclotide
Outcome
IncreaseAbdominal pain/discomfort responders
Study
n = 659
Comparator
Placebo
Analysis
Primary
Outcome group
Pain · Gastrointestinal
Studied dose
290 μg/d · 12 weeksAs given in this study (human).
Measurements
Pain/discomfort responders
62.1%
Linaclotide 290 μg/d
Pain/discomfort responders
53.3%
Placebo
Odds ratio for pain/discomfort response
1.43 OR
Linaclotide vs placebo
95% CI of odds ratio for pain/discomfort response
1.05 to 1.96 OR
Linaclotide vs placebo
Source sentences
Summary
The 12-week abdominal pain/discomfort end-point was met in 62.1% and 53.3% of the linaclotide-treated and placebo-treated patients, respectively (odds ratio [OR] 1.43, 95% confidence interval [CI] 1.05-1.96, P = 0.023)
2 context sentences(design, population, supporting numbers)
Summary · context
In this phase III, double-blind, placebo-controlled trial, IBS-C patients were randomized to receive linaclotide (290 μg/d) or placebo for 12 weeks.
Summary · context
In total, 659 Chinese IBS-C patients received linaclotide (n = 327) or placebo (n = 332).
Report a problemFND-3501922101
02HumanRandomized controlled trialEfficacy outcome
In Chinese IBS-C patients, relief response occurred in 32.7% with linaclotide versus 16.9% with placebo (OR 2.40, 95% CI 1.66-3.47, P < 0.001).
In plain wordsIn Chinese IBS-C patients, linaclotide increased overall relief response compared with placebo.
Peptide
Linaclotide
Outcome
IncreaseIBS degree of relief responders
Study
n = 659
Comparator
Placebo
Analysis
Primary
Outcome group
IBS Symptom Relief · Gastrointestinal
Studied dose
290 μg/d · 12 weeksAs given in this study (human).
Measurements
IBS degree of relief responders
32.7%
Linaclotide 290 μg/d
IBS degree of relief responders
16.9%
Placebo
Odds ratio for IBS degree of relief
2.4 OR
Linaclotide vs placebo
95% CI of odds ratio for IBS degree of relief
1.66 to 3.47 OR
Linaclotide vs placebo
Source sentences
Summary
the 12-week IBS degree of relief end-point was achieved in 32.7% and 16.9% of the patients treated with linaclotide and placebo, respectively (OR 2.40, 95% CI 1.66-3.47, P < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
In this phase III, double-blind, placebo-controlled trial, IBS-C patients were randomized to receive linaclotide (290 μg/d) or placebo for 12 weeks.
Summary · context
In total, 659 Chinese IBS-C patients received linaclotide (n = 327) or placebo (n = 332).
Report a problemFND-3501922102
03HumanRandomized controlled trialEfficacy outcome
In Chinese IBS-C patients, linaclotide improved all secondary endpoints more than placebo from the first 2 weeks (all P < 0.001).
In plain wordsIn Chinese IBS-C patients, linaclotide improved the reported secondary outcomes more than placebo from the first two weeks.
Peptide
Linaclotide
Outcome
IncreaseSecondary endpoints collectively
Study
n = 659
Comparator
Placebo
Analysis
Secondary
Outcome group
IBS Symptom Relief · Gastrointestinal
Studied dose
290 μg/d · 12 weeksAs given in this study (human).
Source sentences
Summary
Linaclotide produced significantly greater improvement than placebo in all secondary end-points from the first 2 weeks (all P < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
In this phase III, double-blind, placebo-controlled trial, IBS-C patients were randomized to receive linaclotide (290 μg/d) or placebo for 12 weeks.
Summary · context
In total, 659 Chinese IBS-C patients received linaclotide (n = 327) or placebo (n = 332).
Report a problemFND-3501922104
04HumanRandomized controlled trialEfficacy outcome
In Chinese IBS-C patients, time to first spontaneous bowel movement was 23.6 h with linaclotide versus 43.7 h with placebo (P < 0.001).
In plain wordsIn Chinese IBS-C patients, linaclotide shortened the time to the first spontaneous bowel movement compared with placebo.
Peptide
Linaclotide
Outcome
DecreaseTime to first spontaneous bowel movement
Study
n = 659
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
290 μg/d · 12 weeksAs given in this study (human).
Measurements
Time to first spontaneous bowel movement
23.6 h
Linaclotide 290 μg/d
Time to first spontaneous bowel movement
43.7 h
Placebo
Source sentences
Summary
The linaclotide-treated patients had a shorter time to the first spontaneous bowel movement than the placebo-treated patients (23.6 h vs 43.7 h, P < 0.001).
2 context sentences(design, population, supporting numbers)
Summary · context
In this phase III, double-blind, placebo-controlled trial, IBS-C patients were randomized to receive linaclotide (290 μg/d) or placebo for 12 weeks.
Summary · context
In total, 659 Chinese IBS-C patients received linaclotide (n = 327) or placebo (n = 332).
Report a problemFND-3501922103
05HumanRandomized controlled trialSafety outcome
In Chinese IBS-C patients, diarrhea occurred in 8.3% with linaclotide versus 1.2% with placebo.
In plain wordsIn Chinese IBS-C patients, diarrhea was more frequent with linaclotide than placebo.
Peptide
Linaclotide
Outcome
IncreaseDiarrhea incidence
Study
n = 659
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
290 μg/d · 12 weeksAs given in this study (human).
Measurements
Diarrhea incidence
8.3%
Linaclotide 290 μg/d
Diarrhea incidence
1.2%
Placebo
Source sentences
Summary
Diarrhea was reported in 8.3% of linaclotide-treated patients and 1.2% of placebo-treated patients.
2 context sentences(design, population, supporting numbers)
Summary · context
In this phase III, double-blind, placebo-controlled trial, IBS-C patients were randomized to receive linaclotide (290 μg/d) or placebo for 12 weeks.
Summary · context
In total, 659 Chinese IBS-C patients received linaclotide (n = 327) or placebo (n = 332).
Report a problemFND-3501922105

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 postedNCT01880424

A Phase 3, International, Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Efficacy and Safety Trial of Linaclotide Administered Orally for 12 Weeks to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

AstraZenecan = 1,722Jul 2013 to May 2015

Irritable Bowel Syndrome With Constipation (IBS-C)

Trial page ClinicalTrials.govUpdated 27 Sept 2016

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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