Randomized Trial of 2 Delayed-Release Formulations of Linaclotide in Patients With Irritable Bowel Syndrome With Constipation.

Chey WD, Sayuk GS, Bartolini W, Reasner DS, Fox SM, Bochenek W, Boinpally R, Shea E, Tripp K, Borgstein N

The American journal of gastroenterology1 Feb 2021Cited by 22 (Europe PMC)

PMID33065589PMCIDPMC8279899DOI10.14309/ajg.0000000000000967PepBankPUB-33065589

Read at source PubMedAsk about this study

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 study13

13 results from studies that gave the peptide. 13 results from people.

01HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, all linaclotide DR1 groups had greater abdominal pain improvements than placebo throughout treatment.
In plain wordsIn IBS-C patients, all linaclotide DR1 groups improved abdominal pain more than placebo.
Peptide
Linaclotide
Outcome
DecreaseAbdominal pain versus placebo, DR1
Study
n: not reported in source
Comparator
Placebo
Outcome group
Pain · Gastrointestinal
Studied dose
DR1 30, 100, or 300 μg once daily · 12 weeksAs given in this study (human).
Source sentences
Summary
All linaclotide DR1 and MD-7246 groups experienced greater improvements in abdominal pain from baseline and vs placebo throughout treatment.
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 2b study randomized patients with IBS with constipation to placebo or 1 of 7 once-daily linaclotide doses (DR1 30, 100, or 300 μg; MD-7246 30, 100, or 300 μg; or IR 290 μg) for 12 weeks.
Report a problemFND-3306558901
02HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, all MD-7246 groups had greater abdominal pain improvements than placebo throughout treatment.
In plain wordsIn IBS-C patients, all MD-7246 groups improved abdominal pain more than placebo.
Peptide
Linaclotide
Outcome
DecreaseAbdominal pain versus placebo, MD-7246
Study
n: not reported in source
Comparator
Placebo
Outcome group
Pain · Gastrointestinal
Studied dose
MD-7246 30, 100, or 300 μg once daily · 12 weeksAs given in this study (human).
Source sentences
Summary
All linaclotide DR1 and MD-7246 groups experienced greater improvements in abdominal pain from baseline and vs placebo throughout treatment.
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 2b study randomized patients with IBS with constipation to placebo or 1 of 7 once-daily linaclotide doses (DR1 30, 100, or 300 μg; MD-7246 30, 100, or 300 μg; or IR 290 μg) for 12 weeks.
Report a problemFND-3306558902
03HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, linaclotide DR1 produced numerically greater improvements in complete spontaneous bowel movement frequency than placebo.
In plain wordsIn IBS-C patients, linaclotide DR1 numerically increased complete spontaneous bowel movements more than placebo.
Peptide
Linaclotide
Outcome
IncreaseComplete spontaneous bowel movement frequency, DR1
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
DR1 30, 100, or 300 μg once daily · 12 weeksAs given in this study (human).
Source sentences
Summary
Linaclotide DR1 and IR led to numerically greater improvements from baseline in complete spontaneous bowel movement frequency and higher APC+1 responder rates compared with placebo; MD-7246 results were similar to placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 2b study randomized patients with IBS with constipation to placebo or 1 of 7 once-daily linaclotide doses (DR1 30, 100, or 300 μg; MD-7246 30, 100, or 300 μg; or IR 290 μg) for 12 weeks.
Report a problemFND-3306558905
04HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, immediate-release linaclotide produced numerically greater improvements in complete spontaneous bowel movement frequency than placebo.
In plain wordsIn IBS-C patients, immediate-release linaclotide numerically increased complete spontaneous bowel movements more than placebo.
Peptide
Linaclotide
Outcome
IncreaseComplete spontaneous bowel movement frequency, IR
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
IR 290 μg once daily · 12 weeksAs given in this study (human).
Source sentences
Summary
Linaclotide DR1 and IR led to numerically greater improvements from baseline in complete spontaneous bowel movement frequency and higher APC+1 responder rates compared with placebo; MD-7246 results were similar to placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 2b study randomized patients with IBS with constipation to placebo or 1 of 7 once-daily linaclotide doses (DR1 30, 100, or 300 μg; MD-7246 30, 100, or 300 μg; or IR 290 μg) for 12 weeks.
Report a problemFND-3306558906
05HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, linaclotide DR1 produced numerically higher APC+1 responder rates than placebo.
In plain wordsIn IBS-C patients, linaclotide DR1 produced numerically higher combined pain and bowel response rates than placebo.
Peptide
Linaclotide
Outcome
IncreaseAPC+1 responder rate, DR1
Study
n: not reported in source
Comparator
Placebo
Outcome group
IBS Symptom Relief · Gastrointestinal
Studied dose
DR1 30, 100, or 300 μg once daily · 12 weeksAs given in this study (human).
Source sentences
Summary
Linaclotide DR1 and IR led to numerically greater improvements from baseline in complete spontaneous bowel movement frequency and higher APC+1 responder rates compared with placebo; MD-7246 results were similar to placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 2b study randomized patients with IBS with constipation to placebo or 1 of 7 once-daily linaclotide doses (DR1 30, 100, or 300 μg; MD-7246 30, 100, or 300 μg; or IR 290 μg) for 12 weeks.
Report a problemFND-3306558909
06HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, immediate-release linaclotide produced numerically higher APC+1 responder rates than placebo.
In plain wordsIn IBS-C patients, immediate-release linaclotide produced numerically higher combined pain and bowel response rates than placebo.
Peptide
Linaclotide
Outcome
IncreaseAPC+1 responder rate, IR
Study
n: not reported in source
Comparator
Placebo
Outcome group
IBS Symptom Relief · Gastrointestinal
Studied dose
IR 290 μg once daily · 12 weeksAs given in this study (human).
Source sentences
Summary
Linaclotide DR1 and IR led to numerically greater improvements from baseline in complete spontaneous bowel movement frequency and higher APC+1 responder rates compared with placebo; MD-7246 results were similar to placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 2b study randomized patients with IBS with constipation to placebo or 1 of 7 once-daily linaclotide doses (DR1 30, 100, or 300 μg; MD-7246 30, 100, or 300 μg; or IR 290 μg) for 12 weeks.
Report a problemFND-3306558910
07HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, MD-7246 results for complete spontaneous bowel movement frequency were similar to placebo.
In plain wordsIn IBS-C patients, MD-7246 and placebo had similar results for complete spontaneous bowel movement frequency.
Peptide
Linaclotide
Outcome
Direction not reportedComplete spontaneous bowel movement frequency, MD-7246
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
MD-7246 30, 100, or 300 μg once daily · 12 weeksAs given in this study (human).
Source sentences
Summary
Linaclotide DR1 and IR led to numerically greater improvements from baseline in complete spontaneous bowel movement frequency and higher APC+1 responder rates compared with placebo; MD-7246 results were similar to placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 2b study randomized patients with IBS with constipation to placebo or 1 of 7 once-daily linaclotide doses (DR1 30, 100, or 300 μg; MD-7246 30, 100, or 300 μg; or IR 290 μg) for 12 weeks.
Report a problemFND-3306558911
08HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, MD-7246 APC+1 responder results were similar to placebo.
In plain wordsIn IBS-C patients, MD-7246 and placebo had similar combined pain and bowel response rates.
Peptide
Linaclotide
Outcome
Direction not reportedAPC+1 responder rate, MD-7246
Study
n: not reported in source
Comparator
Placebo
Outcome group
IBS Symptom Relief · Gastrointestinal
Studied dose
MD-7246 30, 100, or 300 μg once daily · 12 weeksAs given in this study (human).
Source sentences
Summary
Linaclotide DR1 and IR led to numerically greater improvements from baseline in complete spontaneous bowel movement frequency and higher APC+1 responder rates compared with placebo; MD-7246 results were similar to placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 2b study randomized patients with IBS with constipation to placebo or 1 of 7 once-daily linaclotide doses (DR1 30, 100, or 300 μg; MD-7246 30, 100, or 300 μg; or IR 290 μg) for 12 weeks.
Report a problemFND-3306558912
09HumanRandomized controlled trialSafety outcome
In IBS-C patients, diarrhea rates were similar between MD-7246 and placebo.
In plain wordsIn IBS-C patients, MD-7246 and placebo had similar diarrhea rates.
Peptide
Linaclotide
Outcome
No significant changeDiarrhea, MD-7246
Study
n: not reported in source
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
MD-7246 30, 100, or 300 μg once daily · 12 weeksAs given in this study (human).
Source sentences
Summary
Diarrhea was the most common adverse event with DR1 and IR; rates were similar between MD-7246 and placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 2b study randomized patients with IBS with constipation to placebo or 1 of 7 once-daily linaclotide doses (DR1 30, 100, or 300 μg; MD-7246 30, 100, or 300 μg; or IR 290 μg) for 12 weeks.
Report a problemFND-3306558915
10HumanNon-randomized trialEfficacy outcome
In IBS-C patients, all linaclotide DR1 groups improved abdominal pain from baseline throughout treatment.
In plain wordsIn IBS-C patients, all linaclotide DR1 groups improved abdominal pain compared with baseline.
Peptide
Linaclotide
Outcome
DecreaseAbdominal pain from baseline, DR1
Study
n: not reported in source
Comparator
Baseline
Outcome group
Pain · Gastrointestinal
Studied dose
DR1 30, 100, or 300 μg once daily · 12 weeksAs given in this study (human).
Source sentences
Summary
All linaclotide DR1 and MD-7246 groups experienced greater improvements in abdominal pain from baseline and vs placebo throughout treatment.
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 2b study randomized patients with IBS with constipation to placebo or 1 of 7 once-daily linaclotide doses (DR1 30, 100, or 300 μg; MD-7246 30, 100, or 300 μg; or IR 290 μg) for 12 weeks.
Report a problemFND-3306558903
11HumanNon-randomized trialEfficacy outcome
In IBS-C patients, all MD-7246 groups improved abdominal pain from baseline throughout treatment.
In plain wordsIn IBS-C patients, all MD-7246 groups improved abdominal pain compared with baseline.
Peptide
Linaclotide
Outcome
DecreaseAbdominal pain from baseline, MD-7246
Study
n: not reported in source
Comparator
Baseline
Outcome group
Pain · Gastrointestinal
Studied dose
MD-7246 30, 100, or 300 μg once daily · 12 weeksAs given in this study (human).
Source sentences
Summary
All linaclotide DR1 and MD-7246 groups experienced greater improvements in abdominal pain from baseline and vs placebo throughout treatment.
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 2b study randomized patients with IBS with constipation to placebo or 1 of 7 once-daily linaclotide doses (DR1 30, 100, or 300 μg; MD-7246 30, 100, or 300 μg; or IR 290 μg) for 12 weeks.
Report a problemFND-3306558904
12HumanNon-randomized trialSafety outcome
In IBS-C patients, diarrhea was the most common adverse event with linaclotide DR1.
In plain wordsIn IBS-C patients, diarrhea was the most common adverse event with linaclotide DR1.
Peptide
Linaclotide
Outcome
Not applicableDiarrhea, DR1
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
DR1 30, 100, or 300 μg once daily · 12 weeksAs given in this study (human).
Source sentences
Summary
Diarrhea was the most common adverse event with DR1 and IR; rates were similar between MD-7246 and placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 2b study randomized patients with IBS with constipation to placebo or 1 of 7 once-daily linaclotide doses (DR1 30, 100, or 300 μg; MD-7246 30, 100, or 300 μg; or IR 290 μg) for 12 weeks.
Report a problemFND-3306558913
13HumanNon-randomized trialSafety outcome
In IBS-C patients, diarrhea was the most common adverse event with immediate-release linaclotide.
In plain wordsIn IBS-C patients, diarrhea was the most common adverse event with immediate-release linaclotide.
Peptide
Linaclotide
Outcome
Not applicableDiarrhea, IR
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
IR 290 μg once daily · 12 weeksAs given in this study (human).
Source sentences
Summary
Diarrhea was the most common adverse event with DR1 and IR; rates were similar between MD-7246 and placebo.
1 context sentence(design, population, supporting numbers)
Summary · context
This phase 2b study randomized patients with IBS with constipation to placebo or 1 of 7 once-daily linaclotide doses (DR1 30, 100, or 300 μg; MD-7246 30, 100, or 300 μg; or IR 290 μg) for 12 weeks.
Report a problemFND-3306558914

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 postedNCT02559206

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

Ironwood Pharmaceuticals, Inc.n = 75922 Oct 2015 to 30 Sept 2016

Irritable Bowel Syndrome With Constipation

Trial page ClinicalTrials.govUpdated 24 Apr 2020

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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