Impact of linaclotide treatment on work productivity and activity impairment in adults with irritable bowel syndrome with constipation: results from 2 randomized, double-blind, placebo-controlled phase 3 trials.

Buono JL, Tourkodimitris S, Sarocco P, Johnston JM, Carson RT

American health & drug benefits1 Aug 2014Cited by 19 (Europe PMC)

PMID25237424PMCIDPMC4163780PepBankPUB-25237424

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 study11

11 results from studies that gave the peptide. 11 results from people.

01HumanRandomized controlled trialEfficacy outcome
In adults with IBS-C, linaclotide reduced daily activity impairment by 4.7% versus placebo from baseline to week 12 (P <.01).
In plain wordsIn adults with IBS-C, linaclotide reduced daily activity impairment by 4.7% versus placebo at week 12.
Peptide
Linaclotide
Outcome
DecreaseDaily activity impairment at week 12
Study
n = 1,555
Comparator
placebo
Outcome group
Exercise and physical function · Whole body
Studied dose
Dose not stated
Measurements
Activity impairment reduction
4.7%
versus placebo at week 12
Source sentences
Summary
From baseline to week 12, compared with placebo, linaclotide significantly reduced presenteeism by 5.2%, overall work productivity loss by 6.1%, and daily activity impairment by 4.7% (all P <.01) and led to a numerically greater decrease in absenteeism.
4 context sentences(design, population, supporting numbers)
Summary · context
Of the 1602 patients with IBS-C who were randomized in the 2 clinical trials, 1555 (97.1%) completed a baseline and at least 1 postbaseline WPAI:IBS-C assessment and were included in the analysis cohort; 1148 (71.7%) of these patients were employed.
Summary · context
This was a post-hoc analysis of data on IBS-C-related work time missed and work and activity impairment from 2 phase 3 clinical trials that assessed the efficacy and safety of linaclotide therapy in adults with IBS-C.
Summary · context
The Work Productivity and Activity Impairment Questionnaire for IBS-C (WPAI:IBS-C) was self-administered at baseline and at weeks 4, 8, and 12 during the 12-week treatment periods in Trials 1 and 2 and at weeks 16, 20, and 26 during the extended treatment period in Trial 2.
Summary · context
An analysis of covariance was conducted to assess changes from baseline to all study weeks for each WPAI:IBS-C measure.
Report a problemFND-2523742405
02HumanRandomized controlled trialEfficacy outcome
In adults with IBS-C, linaclotide significantly reduced overall work productivity loss versus placebo at all study weeks.
In plain wordsIn adults with IBS-C, linaclotide reduced overall work productivity loss versus placebo at all study weeks.
Peptide
Linaclotide
Outcome
DecreaseOverall work productivity loss across assessments
Study
n: not reported in source
Comparator
placebo
Outcome group
Exercise and physical function · Whole body
Studied dose
Dose not stated
Source sentences
Summary
Once-daily treatment with linaclotide significantly reduced overall work productivity loss and daily activity impairment among patients with IBS-C at all study weeks.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a post-hoc analysis of data on IBS-C-related work time missed and work and activity impairment from 2 phase 3 clinical trials that assessed the efficacy and safety of linaclotide therapy in adults with IBS-C.
Summary · context
The Work Productivity and Activity Impairment Questionnaire for IBS-C (WPAI:IBS-C) was self-administered at baseline and at weeks 4, 8, and 12 during the 12-week treatment periods in Trials 1 and 2 and at weeks 16, 20, and 26 during the extended treatment period in Trial 2.
Summary · context
An analysis of covariance was conducted to assess changes from baseline to all study weeks for each WPAI:IBS-C measure.
Report a problemFND-2523742401
03HumanRandomized controlled trialEfficacy outcome
In adults with IBS-C, linaclotide significantly reduced daily activity impairment versus placebo at all study weeks.
In plain wordsIn adults with IBS-C, linaclotide reduced daily activity impairment versus placebo at all study weeks.
Peptide
Linaclotide
Outcome
DecreaseDaily activity impairment across assessments
Study
n: not reported in source
Comparator
placebo
Outcome group
Exercise and physical function · Whole body
Studied dose
Dose not stated
Source sentences
Summary
Once-daily treatment with linaclotide significantly reduced overall work productivity loss and daily activity impairment among patients with IBS-C at all study weeks.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a post-hoc analysis of data on IBS-C-related work time missed and work and activity impairment from 2 phase 3 clinical trials that assessed the efficacy and safety of linaclotide therapy in adults with IBS-C.
Summary · context
The Work Productivity and Activity Impairment Questionnaire for IBS-C (WPAI:IBS-C) was self-administered at baseline and at weeks 4, 8, and 12 during the 12-week treatment periods in Trials 1 and 2 and at weeks 16, 20, and 26 during the extended treatment period in Trial 2.
Summary · context
An analysis of covariance was conducted to assess changes from baseline to all study weeks for each WPAI:IBS-C measure.
Report a problemFND-2523742402
04HumanRandomized controlled trialEfficacy outcome
In adults with IBS-C, linaclotide reduced presenteeism by 5.2% versus placebo from baseline to week 12 (P <.01).
In plain wordsIn adults with IBS-C, linaclotide reduced presenteeism by 5.2% versus placebo at week 12.
Peptide
Linaclotide
Outcome
DecreasePresenteeism at week 12
Study
n: not reported in source
Comparator
placebo
Outcome group
Exercise and physical function · Whole body
Studied dose
Dose not stated
Measurements
Presenteeism reduction
5.2%
versus placebo at week 12
Source sentences
Summary
From baseline to week 12, compared with placebo, linaclotide significantly reduced presenteeism by 5.2%, overall work productivity loss by 6.1%, and daily activity impairment by 4.7% (all P <.01) and led to a numerically greater decrease in absenteeism.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a post-hoc analysis of data on IBS-C-related work time missed and work and activity impairment from 2 phase 3 clinical trials that assessed the efficacy and safety of linaclotide therapy in adults with IBS-C.
Summary · context
The Work Productivity and Activity Impairment Questionnaire for IBS-C (WPAI:IBS-C) was self-administered at baseline and at weeks 4, 8, and 12 during the 12-week treatment periods in Trials 1 and 2 and at weeks 16, 20, and 26 during the extended treatment period in Trial 2.
Summary · context
An analysis of covariance was conducted to assess changes from baseline to all study weeks for each WPAI:IBS-C measure.
Report a problemFND-2523742403
05HumanRandomized controlled trialEfficacy outcome
In adults with IBS-C, linaclotide reduced overall work productivity loss by 6.1% versus placebo from baseline to week 12 (P <.01).
In plain wordsIn adults with IBS-C, linaclotide reduced work productivity loss by 6.1% versus placebo at week 12.
Peptide
Linaclotide
Outcome
DecreaseWork productivity loss at week 12
Study
n: not reported in source
Comparator
placebo
Outcome group
Exercise and physical function · Whole body
Studied dose
Dose not stated
Measurements
Work productivity loss reduction
6.1%
versus placebo at week 12
Source sentences
Summary
From baseline to week 12, compared with placebo, linaclotide significantly reduced presenteeism by 5.2%, overall work productivity loss by 6.1%, and daily activity impairment by 4.7% (all P <.01) and led to a numerically greater decrease in absenteeism.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a post-hoc analysis of data on IBS-C-related work time missed and work and activity impairment from 2 phase 3 clinical trials that assessed the efficacy and safety of linaclotide therapy in adults with IBS-C.
Summary · context
The Work Productivity and Activity Impairment Questionnaire for IBS-C (WPAI:IBS-C) was self-administered at baseline and at weeks 4, 8, and 12 during the 12-week treatment periods in Trials 1 and 2 and at weeks 16, 20, and 26 during the extended treatment period in Trial 2.
Summary · context
An analysis of covariance was conducted to assess changes from baseline to all study weeks for each WPAI:IBS-C measure.
Report a problemFND-2523742404
06HumanRandomized controlled trialEfficacy outcome
In adults with IBS-C, linaclotide produced a numerically greater decrease in absenteeism than placebo from baseline to week 12.
In plain wordsIn adults with IBS-C, linaclotide reduced absenteeism numerically more than placebo at week 12.
Peptide
Linaclotide
Outcome
DecreaseAbsenteeism at week 12
Study
n: not reported in source
Comparator
placebo
Outcome group
Exercise and physical function · Whole body
Studied dose
Dose not stated
Source sentences
Summary
From baseline to week 12, compared with placebo, linaclotide significantly reduced presenteeism by 5.2%, overall work productivity loss by 6.1%, and daily activity impairment by 4.7% (all P <.01) and led to a numerically greater decrease in absenteeism.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a post-hoc analysis of data on IBS-C-related work time missed and work and activity impairment from 2 phase 3 clinical trials that assessed the efficacy and safety of linaclotide therapy in adults with IBS-C.
Summary · context
The Work Productivity and Activity Impairment Questionnaire for IBS-C (WPAI:IBS-C) was self-administered at baseline and at weeks 4, 8, and 12 during the 12-week treatment periods in Trials 1 and 2 and at weeks 16, 20, and 26 during the extended treatment period in Trial 2.
Summary · context
An analysis of covariance was conducted to assess changes from baseline to all study weeks for each WPAI:IBS-C measure.
Report a problemFND-2523742406
07HumanRandomized controlled trialEfficacy outcome
In adults with IBS-C, linaclotide reduced presenteeism by 5.9% versus placebo from baseline to week 26 (P <.05).
In plain wordsIn adults with IBS-C, linaclotide reduced presenteeism by 5.9% versus placebo at week 26.
Peptide
Linaclotide
Outcome
DecreasePresenteeism at week 26
Study
n: not reported in source
Comparator
placebo
Outcome group
Exercise and physical function · Whole body
Studied dose
Dose not stated
Measurements
Presenteeism reduction
5.9%
versus placebo at week 26
Source sentences
Summary
From baseline to week 26, compared with placebo, reductions with linaclotide were 5.9% for presenteeism, 7.5% for overall work productivity loss, and 6.7% for daily activity impairment (all P <.05).
3 context sentences(design, population, supporting numbers)
Summary · context
This was a post-hoc analysis of data on IBS-C-related work time missed and work and activity impairment from 2 phase 3 clinical trials that assessed the efficacy and safety of linaclotide therapy in adults with IBS-C.
Summary · context
The Work Productivity and Activity Impairment Questionnaire for IBS-C (WPAI:IBS-C) was self-administered at baseline and at weeks 4, 8, and 12 during the 12-week treatment periods in Trials 1 and 2 and at weeks 16, 20, and 26 during the extended treatment period in Trial 2.
Summary · context
An analysis of covariance was conducted to assess changes from baseline to all study weeks for each WPAI:IBS-C measure.
Report a problemFND-2523742407
08HumanRandomized controlled trialEfficacy outcome
In adults with IBS-C, linaclotide reduced overall work productivity loss by 7.5% versus placebo from baseline to week 26 (P <.05).
In plain wordsIn adults with IBS-C, linaclotide reduced work productivity loss by 7.5% versus placebo at week 26.
Peptide
Linaclotide
Outcome
DecreaseWork productivity loss at week 26
Study
n: not reported in source
Comparator
placebo
Outcome group
Exercise and physical function · Whole body
Studied dose
Dose not stated
Measurements
Work productivity loss reduction
7.5%
versus placebo at week 26
Source sentences
Summary
From baseline to week 26, compared with placebo, reductions with linaclotide were 5.9% for presenteeism, 7.5% for overall work productivity loss, and 6.7% for daily activity impairment (all P <.05).
3 context sentences(design, population, supporting numbers)
Summary · context
This was a post-hoc analysis of data on IBS-C-related work time missed and work and activity impairment from 2 phase 3 clinical trials that assessed the efficacy and safety of linaclotide therapy in adults with IBS-C.
Summary · context
The Work Productivity and Activity Impairment Questionnaire for IBS-C (WPAI:IBS-C) was self-administered at baseline and at weeks 4, 8, and 12 during the 12-week treatment periods in Trials 1 and 2 and at weeks 16, 20, and 26 during the extended treatment period in Trial 2.
Summary · context
An analysis of covariance was conducted to assess changes from baseline to all study weeks for each WPAI:IBS-C measure.
Report a problemFND-2523742408
09HumanRandomized controlled trialEfficacy outcome
In adults with IBS-C, linaclotide reduced daily activity impairment by 6.7% versus placebo from baseline to week 26 (P <.05).
In plain wordsIn adults with IBS-C, linaclotide reduced daily activity impairment by 6.7% versus placebo at week 26.
Peptide
Linaclotide
Outcome
DecreaseDaily activity impairment at week 26
Study
n: not reported in source
Comparator
placebo
Outcome group
Exercise and physical function · Whole body
Studied dose
Dose not stated
Measurements
Activity impairment reduction
6.7%
versus placebo at week 26
Source sentences
Summary
From baseline to week 26, compared with placebo, reductions with linaclotide were 5.9% for presenteeism, 7.5% for overall work productivity loss, and 6.7% for daily activity impairment (all P <.05).
3 context sentences(design, population, supporting numbers)
Summary · context
This was a post-hoc analysis of data on IBS-C-related work time missed and work and activity impairment from 2 phase 3 clinical trials that assessed the efficacy and safety of linaclotide therapy in adults with IBS-C.
Summary · context
The Work Productivity and Activity Impairment Questionnaire for IBS-C (WPAI:IBS-C) was self-administered at baseline and at weeks 4, 8, and 12 during the 12-week treatment periods in Trials 1 and 2 and at weeks 16, 20, and 26 during the extended treatment period in Trial 2.
Summary · context
An analysis of covariance was conducted to assess changes from baseline to all study weeks for each WPAI:IBS-C measure.
Report a problemFND-2523742409
10HumanNon-randomized trialEfficacy outcome
In employees with IBS-C, reductions in work productivity loss from baseline to week 26 translated to an estimated 103 to 156 hours annually.
In plain wordsIn employees with IBS-C, work-loss reductions from baseline to week 26 translated to an estimated 103 to 156 hours annually.
Peptide
Linaclotide
Outcome
DecreaseAnnualized avoided work time loss
Study
n: not reported in source
Outcome group
Exercise and physical function · Whole body
Studied dose
Dose not stated
Measurements
Annualized avoided work time
103 to 156 hours annually
derived from week 26 reductions
Source sentences
Summary
Reductions in overall work productivity loss from baseline to week 26 translate to 103 hours to 156 hours annually and correspond to an avoided overall work loss of $3209 to $4861 annually for an employee with IBS-C.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a post-hoc analysis of data on IBS-C-related work time missed and work and activity impairment from 2 phase 3 clinical trials that assessed the efficacy and safety of linaclotide therapy in adults with IBS-C.
Summary · context
The Work Productivity and Activity Impairment Questionnaire for IBS-C (WPAI:IBS-C) was self-administered at baseline and at weeks 4, 8, and 12 during the 12-week treatment periods in Trials 1 and 2 and at weeks 16, 20, and 26 during the extended treatment period in Trial 2.
Summary · context
An analysis of covariance was conducted to assess changes from baseline to all study weeks for each WPAI:IBS-C measure.
Report a problemFND-2523742410
11HumanNon-randomized trialOther
In employees with IBS-C, reductions in work productivity loss from baseline to week 26 corresponded to estimated avoided costs of $3209 to $4861 annually.
In plain wordsIn employees with IBS-C, work-loss reductions from baseline to week 26 corresponded to estimated avoided costs of $3209 to $4861 annually.
Peptide
Linaclotide
Outcome
DecreaseAnnualized avoided work loss cost
Study
n: not reported in source
Outcome group
Cost-effectiveness · Whole body
Studied dose
Dose not stated
Measurements
Avoided annual work loss cost
3209 to 4861 USD annually
derived from week 26 reductions
Source sentences
Summary
Reductions in overall work productivity loss from baseline to week 26 translate to 103 hours to 156 hours annually and correspond to an avoided overall work loss of $3209 to $4861 annually for an employee with IBS-C.
3 context sentences(design, population, supporting numbers)
Summary · context
This was a post-hoc analysis of data on IBS-C-related work time missed and work and activity impairment from 2 phase 3 clinical trials that assessed the efficacy and safety of linaclotide therapy in adults with IBS-C.
Summary · context
The Work Productivity and Activity Impairment Questionnaire for IBS-C (WPAI:IBS-C) was self-administered at baseline and at weeks 4, 8, and 12 during the 12-week treatment periods in Trials 1 and 2 and at weeks 16, 20, and 26 during the extended treatment period in Trial 2.
Summary · context
An analysis of covariance was conducted to assess changes from baseline to all study weeks for each WPAI:IBS-C measure.
Report a problemFND-2523742411

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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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