Linaclotide improves abdominal pain and bowel habits in a phase IIb study of patients with irritable bowel syndrome with constipation.

Johnston JM, Kurtz CB, Macdougall JE, Lavins BJ, Currie MG, Fitch DA, O'Dea C, Baird M, Lembo AJ

Gastroenterology27 Aug 2010Cited by 169 (Europe PMC)

PMID20801122DOI10.1053/j.gastro.2010.08.041PepBankPUB-20801122

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 study7

7 results from studies that gave the peptide. 7 results from people.

01HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, all linaclotide doses improved spontaneous bowel movements, complete spontaneous bowel movements, straining, and stool consistency versus placebo.
In plain wordsIn IBS-C patients, all linaclotide doses improved bowel habits versus placebo.
Peptide
Linaclotide
Outcome
Direction not reportedBowel habits across doses
Study
n = 420
Comparator
Placebo
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
75, 150, 300, or 600 μg once daily · oral · 12 weeksAs given in this study (human).
Source sentences
Summary
All doses of linaclotide significantly improved bowel habits, including frequency of spontaneous bowel movements and complete spontaneous bowel movements (primary end point), severity of straining, and stool consistency.
1 context sentence(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, multicenter, placebo-controlled study of 420 patients with IBS-C given oral linaclotide at doses of 75, 150, 300, or 600 μg or placebo once daily for 12 weeks.
Report a problemFND-2080112201
02HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, most linaclotide doses significantly improved discomfort, bloating, and global IBS-C measures versus placebo.
In plain wordsIn IBS-C patients, most linaclotide doses improved discomfort, bloating, and overall symptoms versus placebo.
Peptide
Linaclotide
Outcome
Direction not reportedOther abdominal symptoms and global measures
Study
n = 420
Comparator
Placebo
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
75, 150, 300, or 600 μg once daily · oral · 12 weeksAs given in this study (human).
Source sentences
Summary
Likewise, most doses of linaclotide significantly improved other abdominal symptoms, including discomfort and bloating, and global measures of IBS-C compared with placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, multicenter, placebo-controlled study of 420 patients with IBS-C given oral linaclotide at doses of 75, 150, 300, or 600 μg or placebo once daily for 12 weeks.
Report a problemFND-2080112206
03HumanRandomized controlled trialSafety outcome
In IBS-C patients, adverse event incidence was similar with linaclotide and placebo, except for diarrhea.
In plain wordsIn IBS-C patients, side effect frequency was similar with linaclotide and placebo, except for diarrhea.
Peptide
Linaclotide
Outcome
Direction not reportedAdverse events except diarrhea
Study
n = 420
Comparator
Placebo
Outcome group
Adverse events · Gastrointestinal
Studied dose
75, 150, 300, or 600 μg once daily · oral · 12 weeksAs given in this study (human).
Source sentences
Summary
Except for diarrhea, the incidence of adverse events was similar between placebo and linaclotide groups.
1 context sentence(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, multicenter, placebo-controlled study of 420 patients with IBS-C given oral linaclotide at doses of 75, 150, 300, or 600 μg or placebo once daily for 12 weeks.
Report a problemFND-2080112208
04HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, mean abdominal pain change from baseline was -0.71 with linaclotide 75 μg versus -0.49 with placebo; abdominal pain was reported as significantly reduced compared with placebo.
In plain wordsIn IBS-C patients, linaclotide reduced abdominal pain more than placebo.
Peptide
Linaclotide
Outcome
DecreaseAbdominal pain change
Study
n: not reported in source
Comparator
Placebo
Outcome group
Pain · Gastrointestinal
Studied dose
75 μg once daily · oral · 12 weeksAs given in this study (human).
Measurements
Mean change in abdominal pain from baseline (5-point scale)
−0.71 points
linaclotide 75 μg once daily
Mean change in abdominal pain from baseline (5-point scale)
−0.49 points
placebo
Source sentences
Summary
Abdominal pain was significantly reduced from baseline, compared with placebo; mean changes in abdominal pain (assessed on a 5-point scale) from baseline were -0.71, -0.71, -0.90, and -0.86 for linaclotide doses of 75, 150, 300, and 600 μg, respectively, compared with -0.49 for placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, multicenter, placebo-controlled study of 420 patients with IBS-C given oral linaclotide at doses of 75, 150, 300, or 600 μg or placebo once daily for 12 weeks.
Report a problemFND-2080112202
05HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, mean abdominal pain change from baseline was -0.71 with linaclotide 150 μg versus -0.49 with placebo; abdominal pain was reported as significantly reduced compared with placebo.
In plain wordsIn IBS-C patients, linaclotide reduced abdominal pain more than placebo.
Peptide
Linaclotide
Outcome
DecreaseAbdominal pain change
Study
n: not reported in source
Comparator
Placebo
Outcome group
Pain · Gastrointestinal
Studied dose
150 μg once daily · oral · 12 weeksAs given in this study (human).
Measurements
Mean change in abdominal pain from baseline (5-point scale)
−0.71 points
linaclotide 150 μg once daily
Mean change in abdominal pain from baseline (5-point scale)
−0.49 points
placebo
Source sentences
Summary
Abdominal pain was significantly reduced from baseline, compared with placebo; mean changes in abdominal pain (assessed on a 5-point scale) from baseline were -0.71, -0.71, -0.90, and -0.86 for linaclotide doses of 75, 150, 300, and 600 μg, respectively, compared with -0.49 for placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, multicenter, placebo-controlled study of 420 patients with IBS-C given oral linaclotide at doses of 75, 150, 300, or 600 μg or placebo once daily for 12 weeks.
Report a problemFND-2080112203
06HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, mean abdominal pain change from baseline was -0.90 with linaclotide 300 μg versus -0.49 with placebo; abdominal pain was reported as significantly reduced compared with placebo.
In plain wordsIn IBS-C patients, linaclotide reduced abdominal pain more than placebo.
Peptide
Linaclotide
Outcome
DecreaseAbdominal pain change
Study
n: not reported in source
Comparator
Placebo
Outcome group
Pain · Gastrointestinal
Studied dose
300 μg once daily · oral · 12 weeksAs given in this study (human).
Measurements
Mean change in abdominal pain from baseline (5-point scale)
−0.9 points
linaclotide 300 μg once daily
Mean change in abdominal pain from baseline (5-point scale)
−0.49 points
placebo
Source sentences
Summary
Abdominal pain was significantly reduced from baseline, compared with placebo; mean changes in abdominal pain (assessed on a 5-point scale) from baseline were -0.71, -0.71, -0.90, and -0.86 for linaclotide doses of 75, 150, 300, and 600 μg, respectively, compared with -0.49 for placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, multicenter, placebo-controlled study of 420 patients with IBS-C given oral linaclotide at doses of 75, 150, 300, or 600 μg or placebo once daily for 12 weeks.
Report a problemFND-2080112204
07HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, mean abdominal pain change from baseline was -0.86 with linaclotide 600 μg versus -0.49 with placebo; abdominal pain was reported as significantly reduced compared with placebo.
In plain wordsIn IBS-C patients, linaclotide reduced abdominal pain more than placebo.
Peptide
Linaclotide
Outcome
DecreaseAbdominal pain change
Study
n: not reported in source
Comparator
Placebo
Outcome group
Pain · Gastrointestinal
Studied dose
600 μg once daily · oral · 12 weeksAs given in this study (human).
Measurements
Mean change in abdominal pain from baseline (5-point scale)
−0.86 points
linaclotide 600 μg once daily
Mean change in abdominal pain from baseline (5-point scale)
−0.49 points
placebo
Source sentences
Summary
Abdominal pain was significantly reduced from baseline, compared with placebo; mean changes in abdominal pain (assessed on a 5-point scale) from baseline were -0.71, -0.71, -0.90, and -0.86 for linaclotide doses of 75, 150, 300, and 600 μg, respectively, compared with -0.49 for placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
We performed a randomized, double-blind, multicenter, placebo-controlled study of 420 patients with IBS-C given oral linaclotide at doses of 75, 150, 300, or 600 μg or placebo once daily for 12 weeks.
Report a problemFND-2080112205

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 postedNCT00460811

Randomized, Double-blind, Dose-range-finding, Phase 2 Study of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Ironwood Pharmaceuticals, Inc.n = 420Apr 2007 to Apr 2008

Irritable Bowel Syndrome With Constipation

Trial page ClinicalTrials.govUpdated 4 Feb 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

Subjects

Terms as the source lists them.

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