Efficacy of linaclotide for patients with chronic constipation.

Lembo AJ, Kurtz CB, Macdougall JE, Lavins BJ, Currie MG, Fitch DA, Jeglinski BI, Johnston JM

Gastroenterology4 Jan 2010Cited by 165 (Europe PMC)

PMID20045700DOI10.1053/j.gastro.2009.12.050PepBankPUB-20045700

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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 study6

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

01HumanRandomized controlled trialEfficacy outcome
In chronic constipation patients, weekly SBMs increased by 2.6 with linaclotide versus 1.5 with placebo (P < or = .05).
In plain wordsIn chronic constipation patients, linaclotide increased weekly spontaneous bowel movements more than placebo.
Peptide
Linaclotide
Outcome
IncreaseWeekly spontaneous bowel movements
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
75 microg once daily · oral · 4 weeksAs given in this study (human).
Measurements
Increase in overall weekly number of SBMs from baseline
2.6 SBMs per week
linaclotide 75 microg once daily
Increase in overall weekly number of SBMs from baseline
1.5 SBMs per week
placebo
Source sentences
Summary
All doses of linaclotide improved the weekly rate of SBM (primary end point) compared with placebo; the increases in overall weekly number of SBMs from baseline were 2.6, 3.3, 3.6, and 4.3 for linaclotide doses of 75, 150, 300, and 600 microg, respectively, compared with 1.5 for placebo (P < or = .0…
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a multicenter, double-blind, placebo-controlled, parallel-group study of 310 patients with chronic constipation.
Summary · context
Patients were randomly assigned to groups given 75, 150, 300, or 600 microg oral linaclotide or placebo once daily for 4 weeks.
Report a problemFND-2004570001
02HumanRandomized controlled trialEfficacy outcome
In chronic constipation patients, weekly SBMs increased by 3.3 with linaclotide versus 1.5 with placebo (P < or = .05).
In plain wordsIn chronic constipation patients, linaclotide increased weekly spontaneous bowel movements more than placebo.
Peptide
Linaclotide
Outcome
IncreaseWeekly spontaneous bowel movements
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
150 microg once daily · oral · 4 weeksAs given in this study (human).
Measurements
Increase in overall weekly number of SBMs from baseline
3.3 SBMs per week
linaclotide 150 microg once daily
Increase in overall weekly number of SBMs from baseline
1.5 SBMs per week
placebo
Source sentences
Summary
All doses of linaclotide improved the weekly rate of SBM (primary end point) compared with placebo; the increases in overall weekly number of SBMs from baseline were 2.6, 3.3, 3.6, and 4.3 for linaclotide doses of 75, 150, 300, and 600 microg, respectively, compared with 1.5 for placebo (P < or = .0…
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a multicenter, double-blind, placebo-controlled, parallel-group study of 310 patients with chronic constipation.
Summary · context
Patients were randomly assigned to groups given 75, 150, 300, or 600 microg oral linaclotide or placebo once daily for 4 weeks.
Report a problemFND-2004570002
03HumanRandomized controlled trialEfficacy outcome
In chronic constipation patients, weekly SBMs increased by 3.6 with linaclotide versus 1.5 with placebo (P < or = .05).
In plain wordsIn chronic constipation patients, linaclotide increased weekly spontaneous bowel movements more than placebo.
Peptide
Linaclotide
Outcome
IncreaseWeekly spontaneous bowel movements
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
300 microg once daily · oral · 4 weeksAs given in this study (human).
Measurements
Increase in overall weekly number of SBMs from baseline
3.6 SBMs per week
linaclotide 300 microg once daily
Increase in overall weekly number of SBMs from baseline
1.5 SBMs per week
placebo
Source sentences
Summary
All doses of linaclotide improved the weekly rate of SBM (primary end point) compared with placebo; the increases in overall weekly number of SBMs from baseline were 2.6, 3.3, 3.6, and 4.3 for linaclotide doses of 75, 150, 300, and 600 microg, respectively, compared with 1.5 for placebo (P < or = .0…
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a multicenter, double-blind, placebo-controlled, parallel-group study of 310 patients with chronic constipation.
Summary · context
Patients were randomly assigned to groups given 75, 150, 300, or 600 microg oral linaclotide or placebo once daily for 4 weeks.
Report a problemFND-2004570003
04HumanRandomized controlled trialEfficacy outcome
In chronic constipation patients, weekly SBMs increased by 4.3 with linaclotide versus 1.5 with placebo (P < or = .05).
In plain wordsIn chronic constipation patients, linaclotide increased weekly spontaneous bowel movements more than placebo.
Peptide
Linaclotide
Outcome
IncreaseWeekly spontaneous bowel movements
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
600 microg once daily · oral · 4 weeksAs given in this study (human).
Measurements
Increase in overall weekly number of SBMs from baseline
4.3 SBMs per week
linaclotide 600 microg once daily
Increase in overall weekly number of SBMs from baseline
1.5 SBMs per week
placebo
Source sentences
Summary
All doses of linaclotide improved the weekly rate of SBM (primary end point) compared with placebo; the increases in overall weekly number of SBMs from baseline were 2.6, 3.3, 3.6, and 4.3 for linaclotide doses of 75, 150, 300, and 600 microg, respectively, compared with 1.5 for placebo (P < or = .0…
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a multicenter, double-blind, placebo-controlled, parallel-group study of 310 patients with chronic constipation.
Summary · context
Patients were randomly assigned to groups given 75, 150, 300, or 600 microg oral linaclotide or placebo once daily for 4 weeks.
Report a problemFND-2004570004
05HumanRandomized controlled trialEfficacy outcome
In chronic constipation patients, linaclotide improved complete SBMs, stool consistency, straining, discomfort, bloating, global assessments, and quality of life versus placebo.
In plain wordsIn chronic constipation patients, linaclotide improved bowel symptoms, abdominal symptoms, global assessments, and quality of life versus placebo.
Peptide
Linaclotide
Outcome
Direction not reportedOther bowel, abdominal, global and quality-of-life endpoints
Study
n = 310
Comparator
Placebo
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
75, 150, 300, or 600 microg once daily · oral · 4 weeksAs given in this study (human).
Source sentences
Summary
Likewise, linaclotide significantly improved the weekly rate of complete SBM, stool consistency, straining, abdominal discomfort, bloating, global assessments, and quality of life.
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a multicenter, double-blind, placebo-controlled, parallel-group study of 310 patients with chronic constipation.
Summary · context
Patients were randomly assigned to groups given 75, 150, 300, or 600 microg oral linaclotide or placebo once daily for 4 weeks.
Report a problemFND-2004570005
06HumanNon-randomized trialSafety outcome
In chronic constipation patients, diarrhea was the most common and only dose-related adverse event with linaclotide.
In plain wordsIn chronic constipation patients, diarrhea was the most common side effect and the only one related to linaclotide dose.
Peptide
Linaclotide
Outcome
Direction not reportedDose-related diarrhea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
75, 150, 300, or 600 microg once daily · oral · 4 weeksAs given in this study (human).
Measurements
Patients who discontinued treatment because of diarrhea
6 patients
linaclotide groups
Source sentences
Summary
The most common and only dose-related adverse event was diarrhea (only 6 patients discontinued treatment because of diarrhea).
2 context sentences(design, population, supporting numbers)
Summary · context
We performed a multicenter, double-blind, placebo-controlled, parallel-group study of 310 patients with chronic constipation.
Summary · context
Patients were randomly assigned to groups given 75, 150, 300, or 600 microg oral linaclotide or placebo once daily for 4 weeks.
Report a problemFND-2004570006

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 2Results postedNCT00402337

Dose-range-finding, Phase 2 Trial of Oral Linaclotide Acetate Administered to Patients With Chronic Constipation

Ironwood Pharmaceuticals, Inc.n = 310Nov 2006 to Feb 2008

Chronic Constipation

Trial page ClinicalTrials.govUpdated 5 Mar 2013

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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