Randomised clinical trials: linaclotide phase 3 studies in IBS-C - a prespecified further analysis based on European Medicines Agency-specified endpoints.

Quigley EM, Tack J, Chey WD, Rao SS, Fortea J, Falques M, Diaz C, Shiff SJ, Currie MG, Johnston JM

Alimentary pharmacology & therapeutics1 Nov 2012Cited by 97 (Europe PMC)

PMID23116208DOI10.1111/apt.12123PepBankPUB-23116208

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 Trial 302, 12-week abdominal pain/discomfort response was greater with linaclotide than placebo: 54.1% versus 38.5% (P < 0.001).
In plain wordsIn IBS-C Trial 302, linaclotide increased abdominal pain/discomfort response versus placebo.
Peptide
Linaclotide
Outcome
IncreaseAbdominal pain/discomfort response, Trial 302
Study
n = 805
Comparator
Placebo
Analysis
Primary
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
290 μg once daily · 12 weeksAs given in this study (human).
Measurements
Responders, 12-week abdominal pain/discomfort
54.1%
linaclotide 290 μg once daily, Trial 302
Responders, 12-week abdominal pain/discomfort
38.5%
placebo, Trial 302
Source sentences
Summary
A significantly greater proportion of linaclotide-treated vs. placebo-treated patients were 12-week abdominal pain/discomfort responders (Trial 31: 54.8% vs. 41.8%; Trial 302: 54.1% vs. 38.5%; P < 0.001) and IBS degree-of-relief responders (Trial 31: 37.0% vs. 18.5%; Trial 302: 39.4% vs. 16.6%; P < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Two randomised, double-blind, multicentre Phase 3 trials investigated once-daily linaclotide (290 μg) for 12 weeks (Trial 31) or 26 weeks (Trial 302) in patients with IBS-C.
Report a problemFND-2311620802
02HumanRandomized controlled trialEfficacy outcome
In IBS-C Trial 302, 12-week degree-of-relief response was greater with linaclotide than placebo: 39.4% versus 16.6% (P < 0.0001).
In plain wordsIn IBS-C Trial 302, linaclotide increased symptom-relief response versus placebo.
Peptide
Linaclotide
Outcome
IncreaseIBS degree-of-relief response, Trial 302
Study
n = 805
Comparator
Placebo
Analysis
Primary
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
290 μg once daily · 12 weeksAs given in this study (human).
Measurements
Responders, 12-week IBS degree-of-relief
39.4%
linaclotide 290 μg once daily, Trial 302
Responders, 12-week IBS degree-of-relief
16.6%
placebo, Trial 302
Source sentences
Summary
A significantly greater proportion of linaclotide-treated vs. placebo-treated patients were 12-week abdominal pain/discomfort responders (Trial 31: 54.8% vs. 41.8%; Trial 302: 54.1% vs. 38.5%; P < 0.001) and IBS degree-of-relief responders (Trial 31: 37.0% vs. 18.5%; Trial 302: 39.4% vs. 16.6%; P < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Two randomised, double-blind, multicentre Phase 3 trials investigated once-daily linaclotide (290 μg) for 12 weeks (Trial 31) or 26 weeks (Trial 302) in patients with IBS-C.
Report a problemFND-2311620804
03HumanRandomized controlled trialEfficacy outcome
In IBS-C Trial 31, abdominal pain/discomfort response was greater with linaclotide than placebo: 54.8% versus 41.8% (P < 0.001).
In plain wordsIn IBS-C Trial 31, linaclotide increased abdominal pain/discomfort response versus placebo.
Peptide
Linaclotide
Outcome
IncreaseAbdominal pain/discomfort response, Trial 31
Study
n = 803
Comparator
Placebo
Analysis
Primary
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
290 μg once daily · 12 weeksAs given in this study (human).
Measurements
Responders, 12-week abdominal pain/discomfort
54.8%
linaclotide 290 μg once daily, Trial 31
Responders, 12-week abdominal pain/discomfort
41.8%
placebo, Trial 31
Source sentences
Summary
A significantly greater proportion of linaclotide-treated vs. placebo-treated patients were 12-week abdominal pain/discomfort responders (Trial 31: 54.8% vs. 41.8%; Trial 302: 54.1% vs. 38.5%; P < 0.001) and IBS degree-of-relief responders (Trial 31: 37.0% vs. 18.5%; Trial 302: 39.4% vs. 16.6%; P < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Two randomised, double-blind, multicentre Phase 3 trials investigated once-daily linaclotide (290 μg) for 12 weeks (Trial 31) or 26 weeks (Trial 302) in patients with IBS-C.
Report a problemFND-2311620801
04HumanRandomized controlled trialEfficacy outcome
In IBS-C Trial 31, degree-of-relief response was greater with linaclotide than placebo: 37.0% versus 18.5% (P < 0.0001).
In plain wordsIn IBS-C Trial 31, linaclotide increased symptom-relief response versus placebo.
Peptide
Linaclotide
Outcome
IncreaseIBS degree-of-relief response, Trial 31
Study
n = 803
Comparator
Placebo
Analysis
Primary
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
290 μg once daily · 12 weeksAs given in this study (human).
Measurements
Responders, 12-week IBS degree-of-relief
37%
linaclotide 290 μg once daily, Trial 31
Responders, 12-week IBS degree-of-relief
18.5%
placebo, Trial 31
Source sentences
Summary
A significantly greater proportion of linaclotide-treated vs. placebo-treated patients were 12-week abdominal pain/discomfort responders (Trial 31: 54.8% vs. 41.8%; Trial 302: 54.1% vs. 38.5%; P < 0.001) and IBS degree-of-relief responders (Trial 31: 37.0% vs. 18.5%; Trial 302: 39.4% vs. 16.6%; P < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Two randomised, double-blind, multicentre Phase 3 trials investigated once-daily linaclotide (290 μg) for 12 weeks (Trial 31) or 26 weeks (Trial 302) in patients with IBS-C.
Report a problemFND-2311620803
05HumanRandomized controlled trialEfficacy outcome
In IBS-C Trial 302, pain/discomfort response for at least 13 weeks was greater with linaclotide than placebo: 53.6% versus 36.0% (P < 0.0001).
In plain wordsIn IBS-C Trial 302, linaclotide increased prolonged pain/discomfort response versus placebo.
Peptide
Linaclotide
Outcome
IncreaseAbdominal pain/discomfort response for at least 13 weeks
Study
n = 805
Comparator
Placebo
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
290 μg once daily · 26 weeksAs given in this study (human).
Measurements
Responders for at least 13 weeks, abdominal pain/discomfort
53.6%
linaclotide 290 μg once daily, Trial 302
Responders for at least 13 weeks, abdominal pain/discomfort
36%
placebo, Trial 302
Source sentences
Summary
Similarly, significantly more linaclotide- vs. placebo-treated patients were responders for ≥13 weeks in Trial 302 (abdominal pain/discomfort: 53.6% vs. 36.0%; IBS degree-of-relief: 37.2% vs. 16.9%; P < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Two randomised, double-blind, multicentre Phase 3 trials investigated once-daily linaclotide (290 μg) for 12 weeks (Trial 31) or 26 weeks (Trial 302) in patients with IBS-C.
Report a problemFND-2311620805
06HumanRandomized controlled trialEfficacy outcome
In IBS-C Trial 302, prolonged degree-of-relief response was greater with linaclotide than placebo: 37.2% versus 16.9% (P < 0.0001).
In plain wordsIn IBS-C Trial 302, linaclotide increased prolonged symptom-relief response versus placebo.
Peptide
Linaclotide
Outcome
IncreaseIBS degree-of-relief response for at least 13 weeks
Study
n = 805
Comparator
Placebo
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
290 μg once daily · 26 weeksAs given in this study (human).
Measurements
Responders for at least 13 weeks, IBS degree-of-relief
37.2%
linaclotide 290 μg once daily, Trial 302
Responders for at least 13 weeks, IBS degree-of-relief
16.9%
placebo, Trial 302
Source sentences
Summary
Similarly, significantly more linaclotide- vs. placebo-treated patients were responders for ≥13 weeks in Trial 302 (abdominal pain/discomfort: 53.6% vs. 36.0%; IBS degree-of-relief: 37.2% vs. 16.9%; P < 0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
Two randomised, double-blind, multicentre Phase 3 trials investigated once-daily linaclotide (290 μg) for 12 weeks (Trial 31) or 26 weeks (Trial 302) in patients with IBS-C.
Report a problemFND-2311620806
07HumanRandomized controlled trialEfficacy outcome
In IBS-C Trial 302, sustained co-primary response was greater with linaclotide than placebo (P < 0.001).
In plain wordsIn IBS-C Trial 302, linaclotide increased sustained response versus placebo.
Peptide
Linaclotide
Outcome
IncreaseSustained co-primary response, Trial 302
Study
n = 805
Comparator
Placebo
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
290 μg once daily · 26 weeksAs given in this study (human).
Source sentences
Summary
The proportion of sustained responders (co-primary endpoint responders plus responders for ≥2 of the last 4 weeks of treatment) was also significantly greater with linaclotide vs. placebo in both trials (P < 0.001).
1 context sentence(design, population, supporting numbers)
Summary · context
Two randomised, double-blind, multicentre Phase 3 trials investigated once-daily linaclotide (290 μg) for 12 weeks (Trial 31) or 26 weeks (Trial 302) in patients with IBS-C.
Report a problemFND-2311620808
08HumanRandomized controlled trialEfficacy outcome
In IBS-C Trial 31, sustained co-primary response was greater with linaclotide than placebo (P < 0.001).
In plain wordsIn IBS-C Trial 31, linaclotide increased sustained response versus placebo.
Peptide
Linaclotide
Outcome
IncreaseSustained co-primary response, Trial 31
Study
n = 803
Comparator
Placebo
Outcome group
Gastrointestinal function · Gastrointestinal
Studied dose
290 μg once daily · 12 weeksAs given in this study (human).
Source sentences
Summary
The proportion of sustained responders (co-primary endpoint responders plus responders for ≥2 of the last 4 weeks of treatment) was also significantly greater with linaclotide vs. placebo in both trials (P < 0.001).
1 context sentence(design, population, supporting numbers)
Summary · context
Two randomised, double-blind, multicentre Phase 3 trials investigated once-daily linaclotide (290 μg) for 12 weeks (Trial 31) or 26 weeks (Trial 302) in patients with IBS-C.
Report a problemFND-2311620807

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · 2 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT00938717

Trial of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Ironwood Pharmaceuticals, Inc.n = 805Jul 2009 to Sept 2010

Irritable Bowel Syndrome With Constipation

Trial page ClinicalTrials.govUpdated 5 Nov 2013

CompletedPhase 3Results postedNCT00948818

Trial of Linaclotide Administered to Patients With Irritable Bowel Syndrome With Constipation

Forest Laboratoriesn = 803Jul 2009 to Aug 2010

Irritable Bowel Syndrome Characterized by Constipation

Trial page ClinicalTrials.govUpdated 30 Jan 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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