Linaclotide for irritable bowel syndrome with constipation: a 26-week, randomized, double-blind, placebo-controlled trial to evaluate efficacy and safety.

Chey WD, Lembo AJ, Lavins BJ, Shiff SJ, Kurtz CB, Currie MG, MacDougall JE, Jia XD, Shao JZ, Fitch DA, Baird MJ, Schneier HA, Johnston JM

The American journal of gastroenterology1 Nov 2012Cited by 357 (Europe PMC)

PMID22986437DOI10.1038/ajg.2012.254PepBankPUB-22986437

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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 study8

8 results from studies that gave the peptide. 8 results from people.

01HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, FDA endpoint response was 33.7% with linaclotide versus 13.9% with placebo (P < 0.0001).
In plain wordsIn IBS-C patients, linaclotide increased FDA endpoint response versus placebo.
Peptide
Linaclotide
Outcome
IncreaseFDA endpoint response over 12 weeks
Study
n = 804
Comparator
Placebo
Analysis
Primary
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
290 μg once daily · oral · 12 weeksAs given in this study (human).
Measurements
FDA end point responders
33.7%
linaclotide 290 μg once daily
FDA end point responders
13.9%
placebo
Number needed to treat
5.1 patients
95% CI 3.9 to 7.1
Source sentences
Summary
33.7 % of linaclotide-treated patients were FDA end point responders, vs. 13.9 % of placebo-treated patients ( P < 0.0001) (number needed to treat = 5.1, 95 % confidence interval (CI): 3.9, 7.1).
2 context sentences(design, population, supporting numbers)
Summary · context
This phase 3, double-blind, parallel-group, placebo-controlled trial randomized IBS-C patients to placebo or 290 μg of oral linaclotide once daily for a 26-week treatment period.
Summary · context
The primary and the secondary efficacy assessments were evaluated over the first 12 weeks of treatment.
Report a problemFND-2298643701
02HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, linaclotide improved remaining primary endpoints versus placebo (P < 0.0001).
In plain wordsIn IBS-C patients, linaclotide improved remaining primary endpoints versus placebo.
Peptide
Linaclotide
Outcome
Direction not reportedRemaining primary endpoints
Study
n = 804
Comparator
Placebo
Analysis
Primary
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
290 μg once daily · oral · 12 weeksAs given in this study (human).
Source sentences
Summary
Remaining primary end points ( P < 0.0001) and all secondary end points ( P < 0.001), including abdominal pain, abdominal bloating, and bowel symptoms (SBM and CSBM rates, Bristol Stool Form Scale (BSFS) score, and straining), were also statistically significantly improved with linaclotide vs. placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
This phase 3, double-blind, parallel-group, placebo-controlled trial randomized IBS-C patients to placebo or 290 μg of oral linaclotide once daily for a 26-week treatment period.
Summary · context
The primary and the secondary efficacy assessments were evaluated over the first 12 weeks of treatment.
Report a problemFND-2298643704
03HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, linaclotide improved abdominal pain, bloating, bowel movement rates, stool form, and straining versus placebo (P < 0.001).
In plain wordsIn IBS-C patients, linaclotide improved abdominal and bowel symptoms versus placebo.
Peptide
Linaclotide
Outcome
Direction not reportedSecondary symptom endpoints
Study
n = 804
Comparator
Placebo
Analysis
Secondary
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
290 μg once daily · oral · 12 weeksAs given in this study (human).
Source sentences
Summary
Remaining primary end points ( P < 0.0001) and all secondary end points ( P < 0.001), including abdominal pain, abdominal bloating, and bowel symptoms (SBM and CSBM rates, Bristol Stool Form Scale (BSFS) score, and straining), were also statistically significantly improved with linaclotide vs. placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
This phase 3, double-blind, parallel-group, placebo-controlled trial randomized IBS-C patients to placebo or 290 μg of oral linaclotide once daily for a 26-week treatment period.
Summary · context
The primary and the secondary efficacy assessments were evaluated over the first 12 weeks of treatment.
Report a problemFND-2298643705
04HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, pain response occurred in 48.9% with linaclotide versus 34.5% with placebo.
In plain wordsIn IBS-C patients, linaclotide increased pain response versus placebo.
Peptide
Linaclotide
Outcome
IncreaseFDA pain criterion response
Study
n = 804
Comparator
Placebo
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
290 μg once daily · oral · 12 weeksAs given in this study (human).
Measurements
Pain responder criterion of FDA end point
48.9%
linaclotide 290 μg once daily
Pain responder criterion of FDA end point
34.5%
placebo
Number needed to treat
7 patients
95% CI 4.7 to 13.1
Source sentences
Summary
The pain responder criterion of the FDA end point was met by 48.9 % of linaclotide-treated patients vs. 34.5 % of placebo-treated patients (number needed to treat = 7.0, 95 % CI: 4.7, 13.1)
2 context sentences(design, population, supporting numbers)
Summary · context
This phase 3, double-blind, parallel-group, placebo-controlled trial randomized IBS-C patients to placebo or 290 μg of oral linaclotide once daily for a 26-week treatment period.
Summary · context
The primary and the secondary efficacy assessments were evaluated over the first 12 weeks of treatment.
Report a problemFND-2298643702
05HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, CSBM response occurred in 47.6% with linaclotide versus 22.6% with placebo.
In plain wordsIn IBS-C patients, linaclotide increased complete bowel movement response versus placebo.
Peptide
Linaclotide
Outcome
IncreaseFDA CSBM criterion response
Study
n = 804
Comparator
Placebo
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
290 μg once daily · oral · 12 weeksAs given in this study (human).
Measurements
CSBM responder criterion of FDA end point
47.6%
linaclotide 290 μg once daily
CSBM responder criterion of FDA end point
22.6%
placebo
Number needed to treat
4 patients
95% CI 3.2 to 5.4
Source sentences
Summary
and the CSBM responder criterion was met by 47.6 % of linaclotide-treated patients, vs. 22.6 % of placebo patients (number needed to treat = 4.0, 95 % CI: 3.2, 5.4).
2 context sentences(design, population, supporting numbers)
Summary · context
This phase 3, double-blind, parallel-group, placebo-controlled trial randomized IBS-C patients to placebo or 290 μg of oral linaclotide once daily for a 26-week treatment period.
Summary · context
The primary and the secondary efficacy assessments were evaluated over the first 12 weeks of treatment.
Report a problemFND-2298643703
06HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, responder and continuous endpoints differed significantly between linaclotide and placebo over 26 weeks.
In plain wordsIn IBS-C patients, response and continuous measures differed between linaclotide and placebo over 26 weeks.
Peptide
Linaclotide
Outcome
Direction not reportedResponder and continuous endpoints over 26 weeks
Study
n = 804
Comparator
Placebo
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
290 μg once daily · oral · 26 weeksAs given in this study (human).
Source sentences
Summary
Statistically significant differences from placebo were observed for responder and continuous end points over 26 weeks of treatment.
2 context sentences(design, population, supporting numbers)
Summary · context
This phase 3, double-blind, parallel-group, placebo-controlled trial randomized IBS-C patients to placebo or 290 μg of oral linaclotide once daily for a 26-week treatment period.
Summary · context
The primary and the secondary efficacy assessments were evaluated over the first 12 weeks of treatment.
Report a problemFND-2298643706
07HumanRandomized 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 event incidence except diarrhea
Study
n = 804
Comparator
Placebo
Outcome group
Adverse events · Gastrointestinal
Studied dose
290 μg once daily · oral · 26 weeksAs given in this study (human).
Source sentences
Summary
AE incidence was similar between treatment groups, except for diarrhea, which caused discontinuation in 4.5 % of linaclotide patients vs. 0.2 % of placebo patients.
2 context sentences(design, population, supporting numbers)
Summary · context
This phase 3, double-blind, parallel-group, placebo-controlled trial randomized IBS-C patients to placebo or 290 μg of oral linaclotide once daily for a 26-week treatment period.
Summary · context
The primary and the secondary efficacy assessments were evaluated over the first 12 weeks of treatment.
Report a problemFND-2298643707
08HumanRandomized controlled trialSafety outcome
In IBS-C patients, diarrhea caused discontinuation in 4.5% with linaclotide versus 0.2% with placebo.
In plain wordsIn IBS-C patients, more people stopped linaclotide because of diarrhea than stopped placebo.
Peptide
Linaclotide
Outcome
IncreaseDiscontinuation due to diarrhea
Study
n = 804
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
290 μg once daily · oral · 26 weeksAs given in this study (human).
Measurements
Discontinuation due to diarrhea
4.5%
linaclotide 290 μg once daily
Discontinuation due to diarrhea
0.2%
placebo
Source sentences
Summary
AE incidence was similar between treatment groups, except for diarrhea, which caused discontinuation in 4.5 % of linaclotide patients vs. 0.2 % of placebo patients.
2 context sentences(design, population, supporting numbers)
Summary · context
This phase 3, double-blind, parallel-group, placebo-controlled trial randomized IBS-C patients to placebo or 290 μg of oral linaclotide once daily for a 26-week treatment period.
Summary · context
The primary and the secondary efficacy assessments were evaluated over the first 12 weeks of treatment.
Report a problemFND-2298643708

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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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