Efficacy of Linaclotide in Reducing Abdominal Symptoms of Bloating, Discomfort, and Pain: A Phase 3B Trial Using a Novel Abdominal Scoring System.

Chang L, Lacy BE, Moshiree B, Kassebaum A, Abel JL, Hanlon J, Bartolini W, Boinpally R, Bochenek W, Fox SM, Mallick M, Tripp K, Omniewski N, Shea E, Borgstein N

The American journal of gastroenterology1 Sept 2021Cited by 36 (Europe PMC)

PMID34465695DOI10.14309/ajg.0000000000001334PepBankPUB-34465695

Publisher page PubMedAsk about this study

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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 study4

4 results from studies that gave the peptide. 4 results from people.

01HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, Abdominal Score changed by -1.9 with linaclotide versus -1.2 with placebo (P < 0.0001).
In plain wordsIn IBS-C patients, linaclotide reduced the combined abdominal symptom score more than placebo.
Peptide
Linaclotide
Outcome
DecreaseOverall Abdominal Score change
Study
n = 614
Comparator
Placebo
Analysis
Primary
Outcome group
IBS Symptom Relief · Gastrointestinal
Studied dose
290 μg daily · 12 weeksAs given in this study (human).
Measurements
Overall change from baseline in Abdominal Score
−1.9 Abdominal Score points (0-10 scale)
linaclotide 290 µg
Overall change from baseline in Abdominal Score
−1.2 Abdominal Score points (0-10 scale)
placebo
Source sentences
Summary
The mean overall CFB AS reduction for linaclotide was -1.9 vs -1.2 for placebo (P < 0.0001)
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with IBS-C with abdominal pain ≥3 (0-10 scale) were randomized to linaclotide 290 μg or placebo daily for 12 weeks.
Report a problemFND-3446569501
02HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, responder rates were 40.5% with linaclotide versus 23.4% with placebo (odds ratio 2.2, 95% confidence interval 1.55-3.12, P < 0.0001).
In plain wordsIn IBS-C patients, linaclotide increased the combined abdominal symptom response rate compared with placebo.
Peptide
Linaclotide
Outcome
Increase6-week/12-week Abdominal Score responders
Study
n = 614
Comparator
Placebo
Analysis
Secondary
Outcome group
IBS Symptom Relief · Gastrointestinal
Studied dose
290 μg daily · 12 weeksAs given in this study (human).
Measurements
6-week/12-week AS responder rate
40.5%
linaclotide 290 µg
6-week/12-week AS responder rate
23.4%
placebo
Odds ratio, linaclotide vs placebo
2.2 odds ratio
6-week/12-week AS responder
95% confidence interval of odds ratio
1.55 to 3.12 odds ratio
6-week/12-week AS responder
Source sentences
Summary
the 6-week/12-week AS responder rate was 40.5% for linaclotide vs 23.4% for placebo (odds ratio = 2.2 [95% confidence interval, 1.55-3.12; P < 0.0001]).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with IBS-C with abdominal pain ≥3 (0-10 scale) were randomized to linaclotide 290 μg or placebo daily for 12 weeks.
Report a problemFND-3446569502
03HumanRandomized controlled trialEfficacy outcome
In IBS-C patients, linaclotide significantly benefited the prespecified Abdominal Score cumulative distribution endpoint versus placebo.
In plain wordsIn IBS-C patients, linaclotide showed a significant benefit over placebo on the abdominal symptom score distribution endpoint.
Peptide
Linaclotide
Outcome
Direction not reported12-week Abdominal Score cumulative distribution
Study
n = 614
Comparator
Placebo
Analysis
Secondary
Outcome group
IBS Symptom Relief · Gastrointestinal
Studied dose
290 μg daily · 12 weeksAs given in this study (human).
Source sentences
Summary
All prespecified end points showed significant benefit of linaclotide vs placebo.
2 context sentences(design, population, supporting numbers)
Summary · context
Secondary end points included CFB in 12-week AS evaluated using cumulative distribution function and 6-week/12-week AS responder (AS improvement ≥2 points for ≥6-week/12-week).
Summary · context
Patients with IBS-C with abdominal pain ≥3 (0-10 scale) were randomized to linaclotide 290 μg or placebo daily for 12 weeks.
Report a problemFND-3446569503
04HumanRandomized controlled trialSafety outcome
In IBS-C patients, diarrhea occurred in 4.6% with linaclotide versus 1.6% with placebo.
In plain wordsIn IBS-C patients, diarrhea was more frequent with linaclotide than placebo.
Peptide
Linaclotide
Outcome
IncreaseDiarrhea incidence
Study
n = 614
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
290 μg daily · 12 weeksAs given in this study (human).
Measurements
Diarrhea treatment-emergent adverse event rate
4.6%
linaclotide 290 µg
Diarrhea treatment-emergent adverse event rate
1.6%
placebo
Source sentences
Summary
Diarrhea was the most common treatment-emergent adverse event (linaclotide = 4.6%, placebo = 1.6%).
1 context sentence(design, population, supporting numbers)
Summary · context
Patients with IBS-C with abdominal pain ≥3 (0-10 scale) were randomized to linaclotide 290 μg or placebo daily for 12 weeks.
Report a problemFND-3446569504

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 3Results postedNCT03573908

A Trial of Linaclotide 290 μg in Patients With Irritable Bowel Syndrome With Constipation (IBS-C)

Ironwood Pharmaceuticals, Inc.n = 61420 Jun 2018 to 10 Apr 2019

Irritable Bowel Syndrome Characterized by Constipation

Trial page ClinicalTrials.govUpdated 1 Dec 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

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