Low-Dose Linaclotide (72 μg) for Chronic Idiopathic Constipation: A 12-Week, Randomized, Double-Blind, Placebo-Controlled Trial.

Schoenfeld P, Lacy BE, Chey WD, Lembo AJ, Kurtz CB, Reasner DS, Bochenek W, Tripp K, Currie MG, Fox SM, Blakesley RE, OʼDea CR, Omniewski ND, Hall ML

The American journal of gastroenterology22 Aug 2017Cited by 60 (Europe PMC)

PMID29091082PMCIDPMC5770595DOI10.1038/ajg.2017.230PepBankPUB-29091082

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Summary

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

Results from this study10

10 results from studies that gave the peptide. 10 results from people.

01HumanRandomized controlled trialEfficacy outcome
In CIC patients, CSBM overall response was 13.4% with linaclotide 72 μg versus 4.7% with placebo (P<0.0001, odds ratio=3.0).
In plain wordsIn constipation patients, complete bowel movement response was higher with linaclotide 72 μg than placebo.
Peptide
Linaclotide
Outcome
IncreaseCSBM overall response
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
72 μg once daily · 12 weeksAs given in this study (human).
Measurements
CSBM overall responders
13.4%
linaclotide 72 μg
CSBM overall responders
4.7%
placebo
Odds ratio
3 ratio
linaclotide 72 μg versus placebo
Source sentences
Summary
The primary endpoint was met by 13.4% of linaclotide 72-μg patients vs. 4.7% of placebo patients (P<0.0001, odds ratio=3.0; statistically significant controlling for multiplicity).
1 context sentence(design, population, supporting numbers)
Summary · context
This double-blind, placebo-controlled trial randomized patients with CIC (Rome III criteria) to once-daily linaclotide 72 μg or 145 μg, or placebo for 12 weeks.
Report a problemFND-2909108201
02HumanRandomized controlled trialEfficacy outcome
In CIC patients, linaclotide 145 μg improved overall CSBM response versus placebo, with a response rate of 12.4%.
In plain wordsIn constipation patients, complete bowel movement response was higher with linaclotide 145 μg than placebo.
Peptide
Linaclotide
Outcome
IncreaseCSBM overall response
Study
n: not reported in source
Comparator
Placebo
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
145 μg once daily · 12 weeksAs given in this study (human).
Measurements
CSBM overall responders
12.4%
linaclotide 145 μg
Source sentences
Summary
Patients treated with linaclotide 145 μg also improved CIC symptoms for the primary (12.4%) and sustained responder endpoint parameters (11.4%) and for all 10 of the secondary endpoint parameters including abdominal discomfort (P<0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
This double-blind, placebo-controlled trial randomized patients with CIC (Rome III criteria) to once-daily linaclotide 72 μg or 145 μg, or placebo for 12 weeks.
Report a problemFND-2909108205
03HumanRandomized controlled trialEfficacy outcome
In CIC patients, linaclotide 72 μg met 9-of-10 secondary endpoints versus placebo (P<0.05).
In plain wordsIn constipation patients, linaclotide 72 μg improved most secondary outcomes compared with placebo.
Peptide
Linaclotide
Outcome
MixedAggregate secondary endpoints
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
72 μg once daily · 12 weeksAs given in this study (human).
Measurements
Secondary endpoints met versus placebo
9 of 10 endpoints
linaclotide 72 μg
Source sentences
Summary
Linaclotide 72-μg patients met 9-of-10 secondary endpoints vs. placebo (P<0.05; abdominal discomfort, P=0.1028).
1 context sentence(design, population, supporting numbers)
Summary · context
This double-blind, placebo-controlled trial randomized patients with CIC (Rome III criteria) to once-daily linaclotide 72 μg or 145 μg, or placebo for 12 weeks.
Report a problemFND-2909108203
04HumanRandomized controlled trialEfficacy outcome
In CIC patients, abdominal discomfort did not differ significantly between linaclotide 72 μg and placebo (P=0.1028).
In plain wordsIn constipation patients, abdominal discomfort did not differ significantly between linaclotide 72 μg and placebo.
Peptide
Linaclotide
Outcome
No significant changeAbdominal discomfort
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Pain · Gastrointestinal
Studied dose
72 μg once daily · 12 weeksAs given in this study (human).
Measurements
P value, abdominal discomfort versus placebo
0.1028 p-value
linaclotide 72 μg versus placebo
Source sentences
Summary
Linaclotide 72-μg patients met 9-of-10 secondary endpoints vs. placebo (P<0.05; abdominal discomfort, P=0.1028).
1 context sentence(design, population, supporting numbers)
Summary · context
This double-blind, placebo-controlled trial randomized patients with CIC (Rome III criteria) to once-daily linaclotide 72 μg or 145 μg, or placebo for 12 weeks.
Report a problemFND-2909108204
05HumanRandomized controlled trialEfficacy outcome
In CIC patients, linaclotide 145 μg improved all 10 secondary endpoints, including abdominal discomfort, versus placebo (P<0.05).
In plain wordsIn constipation patients, linaclotide 145 μg improved all secondary outcomes compared with placebo.
Peptide
Linaclotide
Outcome
Direction not reportedAggregate secondary endpoints
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
145 μg once daily · 12 weeksAs given in this study (human).
Measurements
Secondary endpoints improved versus placebo
10 of 10 endpoints
linaclotide 145 μg
Source sentences
Summary
Patients treated with linaclotide 145 μg also improved CIC symptoms for the primary (12.4%) and sustained responder endpoint parameters (11.4%) and for all 10 of the secondary endpoint parameters including abdominal discomfort (P<0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
This double-blind, placebo-controlled trial randomized patients with CIC (Rome III criteria) to once-daily linaclotide 72 μg or 145 μg, or placebo for 12 weeks.
Report a problemFND-2909108207
06HumanRandomized controlled trialEfficacy outcome
In CIC patients, sustained response occurred in 12.4% with linaclotide 72 μg versus 4.2% with placebo (nominal P<0.0001).
In plain wordsIn constipation patients, sustained response was higher with linaclotide 72 μg than placebo.
Peptide
Linaclotide
Outcome
IncreaseSustained CSBM response
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
72 μg once daily · 12 weeksAs given in this study (human).
Measurements
Sustained responders
12.4%
linaclotide 72 μg
Sustained responders
4.2%
placebo
Source sentences
Summary
Sustained response was achieved by 12.4% of linaclotide 72-μg patients vs. 4.2% of placebo patients (nominal P<0.0001).
1 context sentence(design, population, supporting numbers)
Summary · context
This double-blind, placebo-controlled trial randomized patients with CIC (Rome III criteria) to once-daily linaclotide 72 μg or 145 μg, or placebo for 12 weeks.
Report a problemFND-2909108202
07HumanRandomized controlled trialEfficacy outcome
In CIC patients, linaclotide 145 μg improved sustained CSBM response versus placebo, with a response rate of 11.4%.
In plain wordsIn constipation patients, sustained response was higher with linaclotide 145 μg than placebo.
Peptide
Linaclotide
Outcome
IncreaseSustained CSBM response
Study
n: not reported in source
Comparator
Placebo
Outcome group
Bowel Function · Gastrointestinal
Studied dose
145 μg once daily · 12 weeksAs given in this study (human).
Measurements
Sustained responders
11.4%
linaclotide 145 μg
Source sentences
Summary
Patients treated with linaclotide 145 μg also improved CIC symptoms for the primary (12.4%) and sustained responder endpoint parameters (11.4%) and for all 10 of the secondary endpoint parameters including abdominal discomfort (P<0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
This double-blind, placebo-controlled trial randomized patients with CIC (Rome III criteria) to once-daily linaclotide 72 μg or 145 μg, or placebo for 12 weeks.
Report a problemFND-2909108206
08HumanRandomized controlled trialSafety outcome
In CIC patients, diarrhea caused discontinuation in 2.4% with linaclotide 72 μg versus 0 with placebo.
In plain wordsIn constipation patients, diarrhea discontinuations were more frequent with linaclotide 72 μg than placebo.
Peptide
Linaclotide
Outcome
IncreaseDiarrhea discontinuations
Study
n: not reported in source
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
72 μg once daily · 12 weeksAs given in this study (human).
Measurements
Discontinuation due to diarrhea
2.4%
linaclotide 72 μg
Discontinuation due to diarrhea
0%
placebo
Source sentences
Summary
Diarrhea, the most common AE, was mild in most instances and resulted in discontinuation of 0, 2.4%, and 3.2% of patients in the placebo, linaclotide 72-μg, and linaclotide 145-μg groups, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
This double-blind, placebo-controlled trial randomized patients with CIC (Rome III criteria) to once-daily linaclotide 72 μg or 145 μg, or placebo for 12 weeks.
Report a problemFND-2909108210
09HumanRandomized controlled trialSafety outcome
In CIC patients, diarrhea caused discontinuation in 3.2% with linaclotide 145 μg versus 0 with placebo.
In plain wordsIn constipation patients, diarrhea discontinuations were more frequent with linaclotide 145 μg than placebo.
Peptide
Linaclotide
Outcome
IncreaseDiarrhea discontinuations
Study
n: not reported in source
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
145 μg once daily · 12 weeksAs given in this study (human).
Measurements
Discontinuation due to diarrhea
3.2%
linaclotide 145 μg
Discontinuation due to diarrhea
0%
placebo
Source sentences
Summary
Diarrhea, the most common AE, was mild in most instances and resulted in discontinuation of 0, 2.4%, and 3.2% of patients in the placebo, linaclotide 72-μg, and linaclotide 145-μg groups, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
This double-blind, placebo-controlled trial randomized patients with CIC (Rome III criteria) to once-daily linaclotide 72 μg or 145 μg, or placebo for 12 weeks.
Report a problemFND-2909108211
10HumanNon-randomized trialSafety outcome
In CIC patients receiving linaclotide, diarrhea was the most common adverse event and was usually mild.
In plain wordsIn constipation patients receiving linaclotide, diarrhea was the most common adverse event and was usually mild.
Peptide
Linaclotide
Outcome
Not applicableDiarrhea
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
72 μg or 145 μg once daily · 12 weeksAs given in this study (human).
Source sentences
Summary
Diarrhea, the most common AE, was mild in most instances and resulted in discontinuation of 0, 2.4%, and 3.2% of patients in the placebo, linaclotide 72-μg, and linaclotide 145-μg groups, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
This double-blind, placebo-controlled trial randomized patients with CIC (Rome III criteria) to once-daily linaclotide 72 μg or 145 μg, or placebo for 12 weeks.
Report a problemFND-2909108208

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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

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