Dose-finding study of linaclotide in Japanese patients with chronic constipation: A phase II randomized, double-blind, and placebo-controlled study.

Fukudo S, Miwa H, Nakajima A, Kinoshita Y, Kosako M, Nakagawa A, Akiho H, Kuroishi K, Johnston JM, Currie M, Ohkusa T

Neurogastroenterology and motility7 Aug 2018Cited by 10 (Europe PMC)

PMID30084233DOI10.1111/nmo.13442PepBankPUB-30084233

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Summary

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Text rights: CC BY-NC. Results still quote short attributed sentences.

Results from this study6

6 results from studies that gave the peptide. 6 results from people.

01HumanRandomized controlled trialEfficacy outcome
In Japanese constipation patients, first-week SBM frequency increased by 3.89 with linaclotide 0.0625 mg versus 1.91 with placebo (P < 0.05).
In plain wordsIn Japanese constipation patients, linaclotide 0.0625 mg increased bowel movement frequency more than placebo in the first week.
Peptide
Linaclotide
Outcome
IncreaseFirst-week SBM frequency change
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
0.0625 mgAs given in this study (human).
Measurements
Mean change in SBM frequency, first week
3.89 weekly SBM frequency
linaclotide 0.0625 mg
Mean change in SBM frequency, first week
1.91 weekly SBM frequency
placebo
Source sentences
Summary
The change in SBM frequency during the first week (mean) was 3.89, 3.11, 3.87, and 3.85 for 0.0625 mg, 0.125 mg, 0.25 mg, and 0.5 mg for linaclotide, significantly higher than for placebo (1.91, P < 0.05).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a phase II randomized, double-blind, placebo-controlled, dose-finding study of linaclotide for Japanese patients with CC (n = 382, 64 men, 318 women, age 20-75).
Summary · context
After a baseline period of two weeks, patients were randomized to receive placebo (n = 80), or 0.0625 mg (n = 82), 0.125 mg (n = 71), 0.25 mg (n = 73) or 0.5 mg (n = 76) of linaclotide during a two-week treatment period.
Report a problemFND-3008423301
02HumanRandomized controlled trialEfficacy outcome
In Japanese constipation patients, first-week SBM frequency increased by 3.11 with linaclotide 0.125 mg versus 1.91 with placebo (P < 0.05).
In plain wordsIn Japanese constipation patients, linaclotide 0.125 mg increased bowel movement frequency more than placebo in the first week.
Peptide
Linaclotide
Outcome
IncreaseFirst-week SBM frequency change
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
0.125 mgAs given in this study (human).
Measurements
Mean change in SBM frequency, first week
3.11 weekly SBM frequency
linaclotide 0.125 mg
Mean change in SBM frequency, first week
1.91 weekly SBM frequency
placebo
Source sentences
Summary
The change in SBM frequency during the first week (mean) was 3.89, 3.11, 3.87, and 3.85 for 0.0625 mg, 0.125 mg, 0.25 mg, and 0.5 mg for linaclotide, significantly higher than for placebo (1.91, P < 0.05).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a phase II randomized, double-blind, placebo-controlled, dose-finding study of linaclotide for Japanese patients with CC (n = 382, 64 men, 318 women, age 20-75).
Summary · context
After a baseline period of two weeks, patients were randomized to receive placebo (n = 80), or 0.0625 mg (n = 82), 0.125 mg (n = 71), 0.25 mg (n = 73) or 0.5 mg (n = 76) of linaclotide during a two-week treatment period.
Report a problemFND-3008423302
03HumanRandomized controlled trialEfficacy outcome
In Japanese constipation patients, first-week SBM frequency increased by 3.87 with linaclotide 0.25 mg versus 1.91 with placebo (P < 0.05).
In plain wordsIn Japanese constipation patients, linaclotide 0.25 mg increased bowel movement frequency more than placebo in the first week.
Peptide
Linaclotide
Outcome
IncreaseFirst-week SBM frequency change
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
0.25 mgAs given in this study (human).
Measurements
Mean change in SBM frequency, first week
3.87 weekly SBM frequency
linaclotide 0.25 mg
Mean change in SBM frequency, first week
1.91 weekly SBM frequency
placebo
Source sentences
Summary
The change in SBM frequency during the first week (mean) was 3.89, 3.11, 3.87, and 3.85 for 0.0625 mg, 0.125 mg, 0.25 mg, and 0.5 mg for linaclotide, significantly higher than for placebo (1.91, P < 0.05).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a phase II randomized, double-blind, placebo-controlled, dose-finding study of linaclotide for Japanese patients with CC (n = 382, 64 men, 318 women, age 20-75).
Summary · context
After a baseline period of two weeks, patients were randomized to receive placebo (n = 80), or 0.0625 mg (n = 82), 0.125 mg (n = 71), 0.25 mg (n = 73) or 0.5 mg (n = 76) of linaclotide during a two-week treatment period.
Report a problemFND-3008423303
04HumanRandomized controlled trialEfficacy outcome
In Japanese constipation patients, first-week SBM frequency increased by 3.85 with linaclotide 0.5 mg versus 1.91 with placebo (P < 0.05).
In plain wordsIn Japanese constipation patients, linaclotide 0.5 mg increased bowel movement frequency more than placebo in the first week.
Peptide
Linaclotide
Outcome
IncreaseFirst-week SBM frequency change
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
0.5 mgAs given in this study (human).
Measurements
Mean change in SBM frequency, first week
3.85 weekly SBM frequency
linaclotide 0.5 mg
Mean change in SBM frequency, first week
1.91 weekly SBM frequency
placebo
Source sentences
Summary
The change in SBM frequency during the first week (mean) was 3.89, 3.11, 3.87, and 3.85 for 0.0625 mg, 0.125 mg, 0.25 mg, and 0.5 mg for linaclotide, significantly higher than for placebo (1.91, P < 0.05).
2 context sentences(design, population, supporting numbers)
Summary · context
This was a phase II randomized, double-blind, placebo-controlled, dose-finding study of linaclotide for Japanese patients with CC (n = 382, 64 men, 318 women, age 20-75).
Summary · context
After a baseline period of two weeks, patients were randomized to receive placebo (n = 80), or 0.0625 mg (n = 82), 0.125 mg (n = 71), 0.25 mg (n = 73) or 0.5 mg (n = 76) of linaclotide during a two-week treatment period.
Report a problemFND-3008423304
05HumanRandomized controlled trialEfficacy outcome
In Japanese constipation patients, the CSBM responder improvement was greatest with linaclotide 0.5 mg over the 2 weeks.
In plain wordsIn Japanese constipation patients, the complete bowel movement response improved most with linaclotide 0.5 mg over the 2 weeks.
Peptide
Linaclotide
Outcome
Direction not reportedCSBM responder improvement over 2 weeks
Study
n: not reported in source
Analysis
Secondary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
0.5 mgAs given in this study (human).
Source sentences
Summary
The CSBM responder, which is an important parameter, showed the greatest improvement at the 0.5 mg during the 2 week.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a phase II randomized, double-blind, placebo-controlled, dose-finding study of linaclotide for Japanese patients with CC (n = 382, 64 men, 318 women, age 20-75).
Summary · context
After a baseline period of two weeks, patients were randomized to receive placebo (n = 80), or 0.0625 mg (n = 82), 0.125 mg (n = 71), 0.25 mg (n = 73) or 0.5 mg (n = 76) of linaclotide during a two-week treatment period.
Report a problemFND-3008423305
06HumanNon-randomized trialSafety outcome
In Japanese constipation patients, diarrhea was the most frequent adverse event in linaclotide groups.
In plain wordsIn Japanese constipation 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 · 2 weeksAs given in this study (human).
Source sentences
Summary
The most frequent adverse event in the linaclotide groups was diarrhea.
2 context sentences(design, population, supporting numbers)
Summary · context
This was a phase II randomized, double-blind, placebo-controlled, dose-finding study of linaclotide for Japanese patients with CC (n = 382, 64 men, 318 women, age 20-75).
Summary · context
After a baseline period of two weeks, patients were randomized to receive placebo (n = 80), or 0.0625 mg (n = 82), 0.125 mg (n = 71), 0.25 mg (n = 73) or 0.5 mg (n = 76) of linaclotide during a two-week treatment period.
Report a problemFND-3008423306

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 · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 2NCT02425722

A Study to Evaluate Dose Responses of Efficacy and Safety of ASP0456 in Patient With Chronic Constipation

Astellas Pharma Incn = 38313 Apr 2015 to 31 Oct 2015

Chronic Constipation

Trial page ClinicalTrials.govUpdated 18 Oct 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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