A 12-week, randomized, controlled trial with a 4-week randomized withdrawal period to evaluate the efficacy and safety of linaclotide in irritable bowel syndrome with constipation.

Rao S, Lembo AJ, Shiff SJ, Lavins BJ, Currie MG, Jia XD, Shi K, MacDougall JE, Shao JZ, Eng P, Fox SM, Schneier HA, Kurtz CB, Johnston JM

The American journal of gastroenterology1 Nov 2012Cited by 314 (Europe PMC)

PMID22986440PMCIDPMC3504311DOI10.1038/ajg.2012.255PepBankPUB-22986440

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

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

01HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, FDA endpoint response occurred in 136/405 (33.6%) with linaclotide versus 83/395 (21.0%) with placebo (P < 0.0001).
In plain wordsIn IBS-C patients, linaclotide increased FDA endpoint response versus placebo.
Peptide
Linaclotide
Outcome
IncreaseFDA endpoint response
Study
n = 800
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
33.6%
linaclotide 290 μg once daily, 136/405
FDA end point responders
21%
placebo, 83/395
Number needed to treat
8 patients
95% CI 5.4 to 15.5
Source sentences
Summary
The FDA end point was met by 136 / 405 linaclotide-treated patients (33.6 % ), compared with 83 / 395 placebo-treated patients (21.0 % ) ( P < 0.0001) (number needed to treat: 8.0, 95 % confidence interval: 5.4, 15.5).
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 3, double-blind, parallel-group, placebo-controlled trial randomized IBS-C patients to placebo or 290 μ g oral linaclotide once daily in a 12-week treatment period, followed by a 4-week randomized withdrawal (RW) period.
Report a problemFND-2298644001
02HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, more linaclotide patients than placebo patients responded on the other three primary endpoints (P < 0.05).
In plain wordsIn IBS-C patients, linaclotide increased response on the other primary endpoints versus placebo.
Peptide
Linaclotide
Outcome
IncreaseOther three primary endpoints
Study
n = 800
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
A greater percentage of linaclotide patients vs. placebo patients were also responders for the other three primary end points ( P < 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 3, double-blind, parallel-group, placebo-controlled trial randomized IBS-C patients to placebo or 290 μ g oral linaclotide once daily in a 12-week treatment period, followed by a 4-week randomized withdrawal (RW) period.
Report a problemFND-2298644004
03HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, linaclotide improved all secondary endpoints more than placebo (P < 0.001).
In plain wordsIn IBS-C patients, linaclotide improved secondary endpoints more than placebo.
Peptide
Linaclotide
Outcome
Direction not reportedSecondary endpoints
Study
n = 800
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
Significantly greater improvements were seen in linaclotide vs. placebo patients for all secondary end points ( P < 0.001).
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 3, double-blind, parallel-group, placebo-controlled trial randomized IBS-C patients to placebo or 290 μ g oral linaclotide once daily in a 12-week treatment period, followed by a 4-week randomized withdrawal (RW) period.
Report a problemFND-2298644005
04HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, pain response occurred in 50.1% with linaclotide versus 37.5% with placebo (P = 0.0003).
In plain wordsIn IBS-C patients, linaclotide increased abdominal pain response versus placebo.
Peptide
Linaclotide
Outcome
IncreaseAt least 30% pain reduction for at least 6/12 weeks
Study
n = 800
Comparator
Placebo
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
290 μg once daily · oral · 12 weeksAs given in this study (human).
Measurements
At least 30% abdominal pain reduction for at least 6/12 weeks
50.1%
linaclotide 290 μg once daily
At least 30% abdominal pain reduction for at least 6/12 weeks
37.5%
placebo
Source sentences
Summary
A greater percentage of linaclotide patients, compared with placebo patients, reported for at least 6 / 12 treatment period weeks, a reduction of ≥ 30 % in abdominal pain (50.1 vs. 37.5 % , P = 0.0003) and an increase of ≥ 1 CSBM from baseline (48.6 vs. 29.6 % , P < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 3, double-blind, parallel-group, placebo-controlled trial randomized IBS-C patients to placebo or 290 μ g oral linaclotide once daily in a 12-week treatment period, followed by a 4-week randomized withdrawal (RW) period.
Report a problemFND-2298644002
05HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, CSBM response occurred in 48.6% with linaclotide versus 29.6% with placebo (P < 0.0001).
In plain wordsIn IBS-C patients, linaclotide increased complete bowel movement response versus placebo.
Peptide
Linaclotide
Outcome
IncreaseAt least one additional CSBM for at least 6/12 weeks
Study
n = 800
Comparator
Placebo
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
290 μg once daily · oral · 12 weeksAs given in this study (human).
Measurements
Increase of at least 1 CSBM from baseline for at least 6/12 weeks
48.6%
linaclotide 290 μg once daily
Increase of at least 1 CSBM from baseline for at least 6/12 weeks
29.6%
placebo
Source sentences
Summary
A greater percentage of linaclotide patients, compared with placebo patients, reported for at least 6 / 12 treatment period weeks, a reduction of ≥ 30 % in abdominal pain (50.1 vs. 37.5 % , P = 0.0003) and an increase of ≥ 1 CSBM from baseline (48.6 vs. 29.6 % , P < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 3, double-blind, parallel-group, placebo-controlled trial randomized IBS-C patients to placebo or 290 μ g oral linaclotide once daily in a 12-week treatment period, followed by a 4-week randomized withdrawal (RW) period.
Report a problemFND-2298644003
06HumanRandomized controlled trialSafety outcome
In IBS-C patients, diarrhea caused discontinuation in 5.7% with linaclotide versus 0.3% 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 = 800
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
290 μg once daily · oralAs given in this study (human).
Measurements
Discontinuation due to diarrhea
5.7%
linaclotide 290 μg once daily
Discontinuation due to diarrhea
0.3%
placebo
Source sentences
Summary
Diarrhea, the most common AE, resulted in discontinuation of 5.7 % of linaclotide and 0.3 % of placebo patients.
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 3, double-blind, parallel-group, placebo-controlled trial randomized IBS-C patients to placebo or 290 μ g oral linaclotide once daily in a 12-week treatment period, followed by a 4-week randomized withdrawal (RW) period.
Report a problemFND-2298644009
07HumanNon-randomized trialEfficacy outcome
In IBS-C patients who continued linaclotide during randomized withdrawal, improvement persisted.
In plain wordsIn IBS-C patients who continued linaclotide, symptom improvement persisted during withdrawal assessment.
Peptide
Linaclotide
Outcome
Direction not reportedSustained improvement during randomized withdrawal
Study
n: not reported in source
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
290 μg once daily · oralAs given in this study (human).
Source sentences
Summary
During the RW period, patients remaining on linaclotide showed sustained improvement
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 3, double-blind, parallel-group, placebo-controlled trial randomized IBS-C patients to placebo or 290 μ g oral linaclotide once daily in a 12-week treatment period, followed by a 4-week randomized withdrawal (RW) period.
Report a problemFND-2298644006
08HumanNon-randomized trialEfficacy outcome
In IBS-C patients switched from linaclotide to placebo, symptoms returned during randomized withdrawal.
In plain wordsIn IBS-C patients, symptoms returned after placebo replaced linaclotide.
Peptide
Linaclotide
Outcome
IncreaseSymptom return after withdrawal
Study
n: not reported in source
Comparator
Before linaclotide withdrawal
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
Dose not stated · oralAs given in this study (human).
Source sentences
Summary
patients re-randomized from linaclotide to placebo showed return of symptoms, but without worsening of symptoms relative to baseline.
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 3, double-blind, parallel-group, placebo-controlled trial randomized IBS-C patients to placebo or 290 μ g oral linaclotide once daily in a 12-week treatment period, followed by a 4-week randomized withdrawal (RW) period.
Report a problemFND-2298644007
09HumanNon-randomized trialEfficacy outcome
In IBS-C patients switched from linaclotide to placebo, symptoms did not worsen relative to baseline.
In plain wordsIn IBS-C patients, symptoms did not worsen beyond baseline after placebo replaced linaclotide.
Peptide
Linaclotide
Outcome
Direction not reportedSymptoms after withdrawal relative to baseline
Study
n: not reported in source
Comparator
Baseline
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
Dose not stated · oralAs given in this study (human).
Source sentences
Summary
patients re-randomized from linaclotide to placebo showed return of symptoms, but without worsening of symptoms relative to baseline.
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 3, double-blind, parallel-group, placebo-controlled trial randomized IBS-C patients to placebo or 290 μ g oral linaclotide once daily in a 12-week treatment period, followed by a 4-week randomized withdrawal (RW) period.
Report a problemFND-2298644008

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

Terms as the source lists them.

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