Determining an optimal dose of linaclotide for use in Japanese patients with irritable bowel syndrome with constipation: A phase II randomized, double-blind, placebo-controlled study.

Fukudo S, Nakajima A, Fujiyama Y, Kosako M, Nakagawa A, Akiho H, Nakashima Y, Johnston JM, Miwa H

Neurogastroenterology and motility26 Dec 2017Cited by 23 (Europe PMC)

PMID29278278DOI10.1111/nmo.13275PepBankPUB-29278278

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Summary

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Text rights: CC BY-NC. 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 Japanese IBS-C patients, global relief response was 36.2% with linaclotide 0.0625 mg versus 23.2% with placebo, without significance (P > .05).
In plain wordsIn Japanese IBS-C patients, global response was numerically higher with linaclotide 0.0625 mg than placebo, but not significantly.
Peptide
Linaclotide
Outcome
IncreaseGlobal IBS relief response
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
0.0625 mg · 12 weeksAs given in this study (human).
Measurements
Global relief responder rate
36.2%
linaclotide 0.0625 mg
Global relief responder rate
23.2%
placebo
Response difference
13%
linaclotide 0.0625 mg versus placebo
Source sentences
Summary
The primary endpoint was 23.2%, 36.2%, 38.7%, 34.8%, and 38.3% in placebo (n = 112), 0.0625 (n = 116), 0.125 (n = 111), 0.25 (n = 112), and 0.5 (n = 107) mg of linaclotide groups with the difference from the placebo group in each linaclotide group (13.0%, 15.5%, 11.6%, 15.1%, P > .05).
1 context sentence(design, population, supporting numbers)
Summary · context
Japanese patients with IBS-C diagnosed using Rome III criteria (n = 559, men/women: 49/510) were randomly assigned to 1 of 4 linaclotide doses (0.0625, 0.125, 0.25, or 0.5 mg) or placebo for the 12-week treatment period.
Report a problemFND-2927827801
02HumanRandomized controlled trialEfficacy outcome
In Japanese IBS-C patients, global relief response was 38.7% with linaclotide 0.125 mg versus 23.2% with placebo, without significance (P > .05).
In plain wordsIn Japanese IBS-C patients, global response was numerically higher with linaclotide 0.125 mg than placebo, but not significantly.
Peptide
Linaclotide
Outcome
IncreaseGlobal IBS relief response
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
0.125 mg · 12 weeksAs given in this study (human).
Measurements
Global relief responder rate
38.7%
linaclotide 0.125 mg
Global relief responder rate
23.2%
placebo
Response difference
15.5%
linaclotide 0.125 mg versus placebo
Source sentences
Summary
The primary endpoint was 23.2%, 36.2%, 38.7%, 34.8%, and 38.3% in placebo (n = 112), 0.0625 (n = 116), 0.125 (n = 111), 0.25 (n = 112), and 0.5 (n = 107) mg of linaclotide groups with the difference from the placebo group in each linaclotide group (13.0%, 15.5%, 11.6%, 15.1%, P > .05).
1 context sentence(design, population, supporting numbers)
Summary · context
Japanese patients with IBS-C diagnosed using Rome III criteria (n = 559, men/women: 49/510) were randomly assigned to 1 of 4 linaclotide doses (0.0625, 0.125, 0.25, or 0.5 mg) or placebo for the 12-week treatment period.
Report a problemFND-2927827802
03HumanRandomized controlled trialEfficacy outcome
In Japanese IBS-C patients, global relief response was 34.8% with linaclotide 0.25 mg versus 23.2% with placebo, without significance (P > .05).
In plain wordsIn Japanese IBS-C patients, global response was numerically higher with linaclotide 0.25 mg than placebo, but not significantly.
Peptide
Linaclotide
Outcome
IncreaseGlobal IBS relief response
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
0.25 mg · 12 weeksAs given in this study (human).
Measurements
Global relief responder rate
34.8%
linaclotide 0.25 mg
Global relief responder rate
23.2%
placebo
Response difference
11.6%
linaclotide 0.25 mg versus placebo
Source sentences
Summary
The primary endpoint was 23.2%, 36.2%, 38.7%, 34.8%, and 38.3% in placebo (n = 112), 0.0625 (n = 116), 0.125 (n = 111), 0.25 (n = 112), and 0.5 (n = 107) mg of linaclotide groups with the difference from the placebo group in each linaclotide group (13.0%, 15.5%, 11.6%, 15.1%, P > .05).
1 context sentence(design, population, supporting numbers)
Summary · context
Japanese patients with IBS-C diagnosed using Rome III criteria (n = 559, men/women: 49/510) were randomly assigned to 1 of 4 linaclotide doses (0.0625, 0.125, 0.25, or 0.5 mg) or placebo for the 12-week treatment period.
Report a problemFND-2927827803
04HumanRandomized controlled trialEfficacy outcome
In Japanese IBS-C patients, global relief response was 38.3% with linaclotide 0.5 mg versus 23.2% with placebo, without significance (P > .05).
In plain wordsIn Japanese IBS-C patients, global response was numerically higher with linaclotide 0.5 mg than placebo, but not significantly.
Peptide
Linaclotide
Outcome
IncreaseGlobal IBS relief response
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
0.5 mg · 12 weeksAs given in this study (human).
Measurements
Global relief responder rate
38.3%
linaclotide 0.5 mg
Global relief responder rate
23.2%
placebo
Response difference
15.1%
linaclotide 0.5 mg versus placebo
Source sentences
Summary
The primary endpoint was 23.2%, 36.2%, 38.7%, 34.8%, and 38.3% in placebo (n = 112), 0.0625 (n = 116), 0.125 (n = 111), 0.25 (n = 112), and 0.5 (n = 107) mg of linaclotide groups with the difference from the placebo group in each linaclotide group (13.0%, 15.5%, 11.6%, 15.1%, P > .05).
1 context sentence(design, population, supporting numbers)
Summary · context
Japanese patients with IBS-C diagnosed using Rome III criteria (n = 559, men/women: 49/510) were randomly assigned to 1 of 4 linaclotide doses (0.0625, 0.125, 0.25, or 0.5 mg) or placebo for the 12-week treatment period.
Report a problemFND-2927827804
05HumanRandomized controlled trialEfficacy outcome
In Japanese IBS-C patients, CSBM response was 45.8% with linaclotide 0.5 mg versus 25.9% with placebo (P < .01).
In plain wordsIn Japanese IBS-C patients, complete bowel movement response was higher with linaclotide 0.5 mg than placebo.
Peptide
Linaclotide
Outcome
IncreaseCSBM response
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
0.5 mg · 12 weeksAs given in this study (human).
Measurements
CSBM responder rate
45.8%
linaclotide 0.5 mg
CSBM responder rate
25.9%
placebo
Source sentences
Summary
Monthly responder rate of global assessment of relief of IBS symptoms at month 3 (48.6%), responder rate of CSBM during 12 weeks (45.8%), and responder rate of abdominal pain/discomfort relief during 12 weeks (32.7%) in the 0.5 mg were significantly higher than those in placebo group (29.5%, P < .01…
1 context sentence(design, population, supporting numbers)
Summary · context
Japanese patients with IBS-C diagnosed using Rome III criteria (n = 559, men/women: 49/510) were randomly assigned to 1 of 4 linaclotide doses (0.0625, 0.125, 0.25, or 0.5 mg) or placebo for the 12-week treatment period.
Report a problemFND-2927827806
06HumanRandomized controlled trialEfficacy outcome
In Japanese IBS-C patients, pain/discomfort relief response was 32.7% with linaclotide 0.5 mg versus 18.8% with placebo (P < .05).
In plain wordsIn Japanese IBS-C patients, pain and discomfort relief response was higher with linaclotide 0.5 mg than placebo.
Peptide
Linaclotide
Outcome
IncreaseAbdominal pain/discomfort relief response
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Pain · Gastrointestinal
Studied dose
0.5 mg · 12 weeksAs given in this study (human).
Measurements
Abdominal pain/discomfort relief responder rate
32.7%
linaclotide 0.5 mg
Abdominal pain/discomfort relief responder rate
18.8%
placebo
Source sentences
Summary
Monthly responder rate of global assessment of relief of IBS symptoms at month 3 (48.6%), responder rate of CSBM during 12 weeks (45.8%), and responder rate of abdominal pain/discomfort relief during 12 weeks (32.7%) in the 0.5 mg were significantly higher than those in placebo group (29.5%, P < .01…
1 context sentence(design, population, supporting numbers)
Summary · context
Japanese patients with IBS-C diagnosed using Rome III criteria (n = 559, men/women: 49/510) were randomly assigned to 1 of 4 linaclotide doses (0.0625, 0.125, 0.25, or 0.5 mg) or placebo for the 12-week treatment period.
Report a problemFND-2927827807
07HumanRandomized controlled trialEfficacy outcome
In Japanese IBS-C patients, month 3 global relief response was 48.6% with linaclotide 0.5 mg versus 29.5% with placebo (P < .01).
In plain wordsIn Japanese IBS-C patients, monthly global relief response was higher with linaclotide 0.5 mg than placebo at month 3.
Peptide
Linaclotide
Outcome
IncreaseMonthly global relief response at month 3
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
0.5 mg · 12 weeksAs given in this study (human).
Measurements
Monthly global relief responder rate at month 3
48.6%
linaclotide 0.5 mg
Monthly global relief responder rate at month 3
29.5%
placebo
Source sentences
Summary
Monthly responder rate of global assessment of relief of IBS symptoms at month 3 (48.6%), responder rate of CSBM during 12 weeks (45.8%), and responder rate of abdominal pain/discomfort relief during 12 weeks (32.7%) in the 0.5 mg were significantly higher than those in placebo group (29.5%, P < .01…
1 context sentence(design, population, supporting numbers)
Summary · context
Japanese patients with IBS-C diagnosed using Rome III criteria (n = 559, men/women: 49/510) were randomly assigned to 1 of 4 linaclotide doses (0.0625, 0.125, 0.25, or 0.5 mg) or placebo for the 12-week treatment period.
Report a problemFND-2927827805
08HumanNon-randomized trialSafety outcome
In Japanese IBS-C patients, diarrhea was the most frequent adverse event in linaclotide groups.
In plain wordsIn Japanese IBS-C patients, diarrhea was the most frequent adverse event during linaclotide treatment.
Peptide
Linaclotide
Outcome
Not applicableDiarrhea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
0.0625, 0.125, 0.25, or 0.5 mg · 12 weeksAs given in this study (human).
Source sentences
Summary
The most frequent adverse event in the linaclotide groups was diarrhea.
1 context sentence(design, population, supporting numbers)
Summary · context
Japanese patients with IBS-C diagnosed using Rome III criteria (n = 559, men/women: 49/510) were randomly assigned to 1 of 4 linaclotide doses (0.0625, 0.125, 0.25, or 0.5 mg) or placebo for the 12-week treatment period.
Report a problemFND-2927827808

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

Subjects

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Determining an optimal dose of linaclotide for use in Japanese patients with irritable bowel syndrome with constipation: A phase II randomized, double-blind, placebo-controlled study.

Summary

Results from this study8

Version history

Subjects

Publication types

MeSH terms

Keywords