Efficacy and safety of linaclotide for opioid-induced constipation in patients with chronic noncancer pain syndromes from a phase 2 randomized study.

Brenner DM, Argoff CE, Fox SM, Bochenek W, D'Astoli P, Blakesley RE, Reasner DS, O'Dea CR, Cash BD

Pain1 May 2020Cited by 11 (Europe PMC)

PMID32310620PMCIDPMC7170446DOI10.1097/j.pain.0000000000001754PepBankPUB-32310620

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 study10

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

01HumanRandomized controlled trialEfficacy outcome
In adults with opioid-induced constipation, weekly bowel movements increased by 3.5 with linaclotide versus 1.6 with placebo (P < 0.01).
In plain wordsIn adults with opioid-induced constipation, linaclotide increased weekly spontaneous bowel movements more than placebo.
Peptide
Linaclotide
Outcome
IncreaseSpontaneous bowel movements per week
Study
n = 167
Comparator
Placebo
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
290 µg once daily · 8 weeksAs given in this study (human).
Measurements
Mean change from baseline in SBM frequency
3.5 SBMs/week
linaclotide 290 µg
Mean change from baseline in SBM frequency
1.6 SBMs/week
placebo
Source sentences
Summary
The mean changes from baseline in SBMs/week during the treatment period were 2.9 and 3.5 in the linaclotide 145 and 290 µg groups (P < 0.01 for both doses), respectively, vs 1.6 in the placebo group.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with OIC (<3 spontaneous bowel movements [SBMs]/week) related to chronic noncancer pain were randomized 1:1:1 to receive linaclotide 145 µg, linaclotide 290 µg, or placebo once daily for 8 weeks.
Report a problemFND-3231062002
02HumanRandomized controlled trialEfficacy outcome
In adults with opioid-induced constipation, weekly bowel movements increased by 2.9 with linaclotide versus 1.6 with placebo (P < 0.01).
In plain wordsIn adults with opioid-induced constipation, linaclotide increased weekly spontaneous bowel movements more than placebo.
Peptide
Linaclotide
Outcome
IncreaseSpontaneous bowel movements per week
Study
n = 166
Comparator
Placebo
Analysis
Primary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
145 µg once daily · 8 weeksAs given in this study (human).
Measurements
Mean change from baseline in SBM frequency
2.9 SBMs/week
linaclotide 145 µg
Mean change from baseline in SBM frequency
1.6 SBMs/week
placebo
Source sentences
Summary
The mean changes from baseline in SBMs/week during the treatment period were 2.9 and 3.5 in the linaclotide 145 and 290 µg groups (P < 0.01 for both doses), respectively, vs 1.6 in the placebo group.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with OIC (<3 spontaneous bowel movements [SBMs]/week) related to chronic noncancer pain were randomized 1:1:1 to receive linaclotide 145 µg, linaclotide 290 µg, or placebo once daily for 8 weeks.
Report a problemFND-3231062001
03HumanRandomized controlled trialEfficacy outcome
In adults with opioid-induced constipation, linaclotide improved stool consistency more than placebo (P < 0.05).
In plain wordsIn adults with opioid-induced constipation, linaclotide improved stool consistency more than placebo.
Peptide
Linaclotide
Outcome
Direction not reportedStool consistency
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
145 and 290 µg once daily · 8 weeksAs given in this study (human).
Source sentences
Summary
Compared with placebo, linaclotide-treated patients had significant improvements in stool consistency, straining, abdominal bloating, and treatment satisfaction scores (P < 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with OIC (<3 spontaneous bowel movements [SBMs]/week) related to chronic noncancer pain were randomized 1:1:1 to receive linaclotide 145 µg, linaclotide 290 µg, or placebo once daily for 8 weeks.
Report a problemFND-3231062007
04HumanRandomized controlled trialEfficacy outcome
In adults with opioid-induced constipation, linaclotide improved straining more than placebo (P < 0.05).
In plain wordsIn adults with opioid-induced constipation, linaclotide improved straining more than placebo.
Peptide
Linaclotide
Outcome
Direction not reportedStraining
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
145 and 290 µg once daily · 8 weeksAs given in this study (human).
Source sentences
Summary
Compared with placebo, linaclotide-treated patients had significant improvements in stool consistency, straining, abdominal bloating, and treatment satisfaction scores (P < 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with OIC (<3 spontaneous bowel movements [SBMs]/week) related to chronic noncancer pain were randomized 1:1:1 to receive linaclotide 145 µg, linaclotide 290 µg, or placebo once daily for 8 weeks.
Report a problemFND-3231062008
05HumanRandomized controlled trialEfficacy outcome
In adults with opioid-induced constipation, linaclotide improved abdominal bloating more than placebo (P < 0.05).
In plain wordsIn adults with opioid-induced constipation, linaclotide improved abdominal bloating more than placebo.
Peptide
Linaclotide
Outcome
Direction not reportedAbdominal bloating
Study
n: not reported in source
Comparator
Placebo
Analysis
Secondary
Outcome group
Bowel Function · Gastrointestinal
Studied dose
145 and 290 µg once daily · 8 weeksAs given in this study (human).
Source sentences
Summary
Compared with placebo, linaclotide-treated patients had significant improvements in stool consistency, straining, abdominal bloating, and treatment satisfaction scores (P < 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with OIC (<3 spontaneous bowel movements [SBMs]/week) related to chronic noncancer pain were randomized 1:1:1 to receive linaclotide 145 µg, linaclotide 290 µg, or placebo once daily for 8 weeks.
Report a problemFND-3231062009
06HumanRandomized controlled trialSafety outcome
In adults with opioid-induced constipation, no serious diarrhea-related adverse events occurred in any group, including linaclotide and placebo.
In plain wordsIn adults with opioid-induced constipation, neither linaclotide nor placebo groups reported serious diarrhea-related adverse events.
Peptide
Linaclotide
Outcome
No significant changeSerious adverse events related to diarrhea
Study
n = 254
Comparator
Placebo
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
145 and 290 µg once daily · 8 weeksAs given in this study (human).
Source sentences
Summary
No serious AEs related to diarrhea were reported in any treatment group.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with OIC (<3 spontaneous bowel movements [SBMs]/week) related to chronic noncancer pain were randomized 1:1:1 to receive linaclotide 145 µg, linaclotide 290 µg, or placebo once daily for 8 weeks.
Report a problemFND-3231062006
07HumanRandomized controlled trialSafety outcome
In adults with opioid-induced constipation, diarrhea caused discontinuation in 5.7% with linaclotide versus 1.3% with placebo.
In plain wordsIn adults with opioid-induced constipation, diarrhea-related discontinuation was numerically more frequent with linaclotide than placebo.
Peptide
Linaclotide
Outcome
IncreaseDiscontinuation due to diarrhea
Study
n = 167
Comparator
Placebo
Outcome group
Adverse events · Gastrointestinal
Studied dose
290 µg once daily · 8 weeksAs given in this study (human).
Measurements
Discontinuation due to diarrhea
5.7%
linaclotide 290 µg
Discontinuation due to diarrhea
1.3%
placebo
Source sentences
Summary
Diarrhea, the most common AE, was generally mild, resulting in 1.1%, 5.7%, and 1.3% of patients discontinuing in the linaclotide 145 μg, linaclotide 290 μg, and placebo groups, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with OIC (<3 spontaneous bowel movements [SBMs]/week) related to chronic noncancer pain were randomized 1:1:1 to receive linaclotide 145 µg, linaclotide 290 µg, or placebo once daily for 8 weeks.
Report a problemFND-3231062005
08HumanRandomized controlled trialSafety outcome
In adults with opioid-induced constipation, diarrhea caused discontinuation in 1.1% with linaclotide versus 1.3% with placebo.
In plain wordsIn adults with opioid-induced constipation, diarrhea-related discontinuation was numerically less frequent with linaclotide than placebo.
Peptide
Linaclotide
Outcome
DecreaseDiscontinuation due to diarrhea
Study
n = 166
Comparator
Placebo
Outcome group
Adverse events · Gastrointestinal
Studied dose
145 µg once daily · 8 weeksAs given in this study (human).
Measurements
Discontinuation due to diarrhea
1.1%
linaclotide 145 µg
Discontinuation due to diarrhea
1.3%
placebo
Source sentences
Summary
Diarrhea, the most common AE, was generally mild, resulting in 1.1%, 5.7%, and 1.3% of patients discontinuing in the linaclotide 145 μg, linaclotide 290 μg, and placebo groups, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with OIC (<3 spontaneous bowel movements [SBMs]/week) related to chronic noncancer pain were randomized 1:1:1 to receive linaclotide 145 µg, linaclotide 290 µg, or placebo once daily for 8 weeks.
Report a problemFND-3231062004
09HumanRandomized controlled trialEfficacy outcome
In adults with opioid-induced constipation, linaclotide improved treatment satisfaction scores more than placebo (P < 0.05).
In plain wordsIn adults with opioid-induced constipation, linaclotide improved treatment satisfaction more than placebo.
Peptide
Linaclotide
Outcome
Direction not reportedTreatment satisfaction
Study
n: not reported in source
Comparator
Placebo
Outcome group
Patient-reported outcomes · Gastrointestinal
Studied dose
145 and 290 µg once daily · 8 weeksAs given in this study (human).
Source sentences
Summary
Compared with placebo, linaclotide-treated patients had significant improvements in stool consistency, straining, abdominal bloating, and treatment satisfaction scores (P < 0.05).
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with OIC (<3 spontaneous bowel movements [SBMs]/week) related to chronic noncancer pain were randomized 1:1:1 to receive linaclotide 145 µg, linaclotide 290 µg, or placebo once daily for 8 weeks.
Report a problemFND-3231062010
10HumanNon-randomized trialSafety outcome
In adults with opioid-induced constipation, diarrhea was the most common adverse event with linaclotide and was generally mild.
In plain wordsIn adults with opioid-induced constipation, diarrhea was the most common linaclotide adverse event and was generally mild.
Peptide
Linaclotide
Outcome
Not applicableDiarrhea severity
Study
n: not reported in source
Outcome group
Gastrointestinal adverse events · Gastrointestinal
Studied dose
145 and 290 µg once daily · 8 weeksAs given in this study (human).
Source sentences
Summary
Diarrhea, the most common AE, was generally mild, resulting in 1.1%, 5.7%, and 1.3% of patients discontinuing in the linaclotide 145 μg, linaclotide 290 μg, and placebo groups, respectively.
1 context sentence(design, population, supporting numbers)
Summary · context
Adults with OIC (<3 spontaneous bowel movements [SBMs]/week) related to chronic noncancer pain were randomized 1:1:1 to receive linaclotide 145 µg, linaclotide 290 µg, or placebo once daily for 8 weeks.
Report a problemFND-3231062003

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 postedNCT02270983

Phase 2 Randomized, Double-Blind, Placebo-Controlled, Parallel Group Trial of Linaclotide Administered to Patients With Opioid-Induced Constipation Receiving Chronic Opioid Treatment for Non-Cancer Pain

Forest Laboratoriesn = 25431 Oct 2014 to 31 Oct 2015

Opioid-Induced Constipation

Trial page ClinicalTrials.govUpdated 8 Apr 2019

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.

Publication types

MeSH terms

PepBank is a research reference. Talk to a doctor before you use any peptide.