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Study · Randomized controlled trial · 2015

9 results

Linaclotide in Chronic Idiopathic Constipation Patients with Moderate to Severe Abdominal Bloating: A Randomized, Controlled Trial.

Lacy BE, Schey R, Shiff SJ, Lavins BJ, Fox SM, Jia XD, Blakesley RE, Hao X, Cronin JA, Currie MG, Kurtz CB, Johnston JM, Lembo AJ

PloS one29 Jul 2015Cited by 64 (Europe PMC)

PMID26222318 (opens in a new tab)PMCIDPMC4519259 (opens in a new tab)DOI10.1371/journal.pone.0134349 (opens in a new tab)PepBankPUB-26222318
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Summary

BackgroundAbdominal bloating is a common and bothersome symptom of chronic idiopathic constipation. The objective of this trial was to evaluate the efficacy and safety of linaclotide in patients with chronic idiopathic constipation and concomitant moderate-to-severe abdominal bloating.MethodsThis Phase 3b, randomized, double-blind, placebo-controlled clinical trial randomized patients to oral linaclotide (145 or 290 μg) or placebo once daily for 12 weeks. Eligible patients met Rome II criteria for chronic constipation upon entry with an average abdominal bloating score ≥5 (self-assessment: 0 10-point numerical rating scale) during the 14-day baseline period. Patients reported abdominal symptoms (including bloating) and bowel symptoms daily; adverse events were monitored. The primary responder endpoint required patients to have ≥3 complete spontaneous bowel movements/week with an increase of ≥1 from baseline, for ≥9 of 12 weeks. The primary endpoint compared linaclotide 145 μg vs. placebo.ResultsThe intent-to-treat population included 483 patients (mean age=47.3 years, female=91.5%, white=67.7%). The primary endpoint was met by 15.7% of linaclotide 145 μg patients vs. 7.6% of placebo patients (P<0.05). Both linaclotide doses significantly improved abdominal bloating vs. placebo (P<0.05 for all secondary endpoints, controlling for multiplicity). Approximately one-third of linaclotide patients (each group) had ≥50% mean decrease from baseline in abdominal bloating vs. 18% of placebo patients (P<0.01). Diarrhea was reported in 6% and 17% of linaclotide 145 and 290 μg patients, respectively, and 2% of placebo patients. AEs resulted in premature discontinuation of 5% and 9% of linaclotide 145 μg and 290 μg patients, respectively, and 6% of placebo patients.ConclusionsOnce-daily linaclotide (145 and 290 μg) significantly improved bowel and abdominal symptoms in chronic idiopathic constipation patients with moderate-to-severe baseline abdominal bloating; in particular, linaclotide significantly improved abdominal bloating compared to placebo, an important finding given the lack of agents available to treat abdominal bloating in chronic idiopathic constipation patients.Trial registrationClinicalTrials.gov NCT01642914.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study9

9 results from studies that gave the peptide. 9 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In constipation patients with bloating, 15.7% on linaclotide 145 μg met the primary endpoint versus 7.6% on placebo (P<0.05).

    In plain wordsIn constipation patients with bloating, primary response was 15.7% with linaclotide 145 μg versus 7.6% with placebo.

    Peptide
    Linaclotide
    Outcome
    IncreasePrimary CSBM response
    Study

    n: not reported in source

    Comparator
    placebo
    Analysis
    Primary
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    145 μg once daily · oral · 12 weeksAs given in this study (human).

    Measurements

    Primary response
    15.7%
    linaclotide 145 μg
    Primary response
    7.6%
    placebo

    Source sentences

    Summary
    The primary endpoint was met by 15.7% of linaclotide 145 μg patients vs. 7.6% of placebo patients (P<0.05).
    2 context sentences
    Summary · context
    The primary responder endpoint required patients to have ≥3 complete spontaneous bowel movements/week with an increase of ≥1 from baseline, for ≥9 of 12 weeks. The primary endpoint compared linaclotide 145 μg vs. placebo.
    Summary · context
    This Phase 3b, randomized, double-blind, placebo-controlled clinical trial randomized patients to oral linaclotide (145 or 290 μg) or placebo once daily for 12 weeks. Eligible patients met Rome II criteria for chronic constipation upon entry with an average abdominal bloating score ≥5 (self-assessment: 0 10-point numerical rating scale) during the 14-day baseline period.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In constipation patients with bloating, linaclotide 145 μg improved bloating versus placebo (P<0.05).

    In plain wordsIn constipation patients with bloating, linaclotide 145 μg improved bloating versus placebo.

    Peptide
    Linaclotide
    Outcome
    DecreaseAbdominal bloating
    Study

    n: not reported in source

    Comparator
    placebo
    Analysis
    Secondary
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    145 μg once daily · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Both linaclotide doses significantly improved abdominal bloating vs. placebo (P<0.05 for all secondary endpoints, controlling for multiplicity).
    1 context sentence
    Summary · context
    This Phase 3b, randomized, double-blind, placebo-controlled clinical trial randomized patients to oral linaclotide (145 or 290 μg) or placebo once daily for 12 weeks. Eligible patients met Rome II criteria for chronic constipation upon entry with an average abdominal bloating score ≥5 (self-assessment: 0 10-point numerical rating scale) during the 14-day baseline period.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In constipation patients with bloating, linaclotide 290 μg improved bloating versus placebo (P<0.05).

    In plain wordsIn constipation patients with bloating, linaclotide 290 μg improved bloating versus placebo.

    Peptide
    Linaclotide
    Outcome
    DecreaseAbdominal bloating
    Study

    n: not reported in source

    Comparator
    placebo
    Analysis
    Secondary
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    290 μg once daily · oral · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    Both linaclotide doses significantly improved abdominal bloating vs. placebo (P<0.05 for all secondary endpoints, controlling for multiplicity).
    1 context sentence
    Summary · context
    This Phase 3b, randomized, double-blind, placebo-controlled clinical trial randomized patients to oral linaclotide (145 or 290 μg) or placebo once daily for 12 weeks. Eligible patients met Rome II criteria for chronic constipation upon entry with an average abdominal bloating score ≥5 (self-assessment: 0 10-point numerical rating scale) during the 14-day baseline period.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In constipation patients, approximately one-third on linaclotide 145 μg had at least 50% bloating reduction versus 18% on placebo (P<0.01).

    In plain wordsIn constipation patients, approximately one-third on linaclotide 145 μg had at least 50% bloating reduction versus 18% on placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseAt least 50% bloating reduction response
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    145 μg once daily · oral · 12 weeksAs given in this study (human).

    Measurements

    Patients with at least 50% mean decrease from baseline in abdominal bloating
    18%
    placebo

    Source sentences

    Summary
    Approximately one-third of linaclotide patients (each group) had ≥50% mean decrease from baseline in abdominal bloating vs. 18% of placebo patients (P<0.01).
    1 context sentence
    Summary · context
    This Phase 3b, randomized, double-blind, placebo-controlled clinical trial randomized patients to oral linaclotide (145 or 290 μg) or placebo once daily for 12 weeks. Eligible patients met Rome II criteria for chronic constipation upon entry with an average abdominal bloating score ≥5 (self-assessment: 0 10-point numerical rating scale) during the 14-day baseline period.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In constipation patients, approximately one-third on linaclotide 290 μg had at least 50% bloating reduction versus 18% on placebo (P<0.01).

    In plain wordsIn constipation patients, approximately one-third on linaclotide 290 μg had at least 50% bloating reduction versus 18% on placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseAt least 50% bloating reduction response
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    290 μg once daily · oral · 12 weeksAs given in this study (human).

    Measurements

    Patients with at least 50% mean decrease from baseline in abdominal bloating
    18%
    placebo

    Source sentences

    Summary
    Approximately one-third of linaclotide patients (each group) had ≥50% mean decrease from baseline in abdominal bloating vs. 18% of placebo patients (P<0.01).
    1 context sentence
    Summary · context
    This Phase 3b, randomized, double-blind, placebo-controlled clinical trial randomized patients to oral linaclotide (145 or 290 μg) or placebo once daily for 12 weeks. Eligible patients met Rome II criteria for chronic constipation upon entry with an average abdominal bloating score ≥5 (self-assessment: 0 10-point numerical rating scale) during the 14-day baseline period.
  6. 06HumanRandomized controlled trialSafety outcome

    In constipation patients with bloating, diarrhea occurred in 6% on linaclotide 145 μg versus 2% on placebo.

    In plain wordsIn constipation patients with bloating, diarrhea occurred in 6% with linaclotide 145 μg versus 2% with placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseDiarrhea
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    145 μg once daily · oral · 12 weeksAs given in this study (human).

    Measurements

    Diarrhea
    6%
    linaclotide 145 μg
    Diarrhea
    2%
    placebo

    Source sentences

    Summary
    Diarrhea was reported in 6% and 17% of linaclotide 145 and 290 μg patients, respectively, and 2% of placebo patients.
    1 context sentence
    Summary · context
    This Phase 3b, randomized, double-blind, placebo-controlled clinical trial randomized patients to oral linaclotide (145 or 290 μg) or placebo once daily for 12 weeks. Eligible patients met Rome II criteria for chronic constipation upon entry with an average abdominal bloating score ≥5 (self-assessment: 0 10-point numerical rating scale) during the 14-day baseline period.
  7. 07HumanRandomized controlled trialSafety outcome

    In constipation patients with bloating, diarrhea occurred in 17% on linaclotide 290 μg versus 2% on placebo.

    In plain wordsIn constipation patients with bloating, diarrhea occurred in 17% with linaclotide 290 μg versus 2% with placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseDiarrhea
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    290 μg once daily · oral · 12 weeksAs given in this study (human).

    Measurements

    Diarrhea
    17%
    linaclotide 290 μg
    Diarrhea
    2%
    placebo

    Source sentences

    Summary
    Diarrhea was reported in 6% and 17% of linaclotide 145 and 290 μg patients, respectively, and 2% of placebo patients.
    1 context sentence
    Summary · context
    This Phase 3b, randomized, double-blind, placebo-controlled clinical trial randomized patients to oral linaclotide (145 or 290 μg) or placebo once daily for 12 weeks. Eligible patients met Rome II criteria for chronic constipation upon entry with an average abdominal bloating score ≥5 (self-assessment: 0 10-point numerical rating scale) during the 14-day baseline period.
  8. 08HumanRandomized controlled trialSafety outcome

    In constipation patients with bloating, adverse events caused discontinuation in 5% on linaclotide 145 μg versus 6% on placebo.

    In plain wordsIn constipation patients with bloating, adverse events caused discontinuation in 5% with linaclotide 145 μg versus 6% with placebo.

    Peptide
    Linaclotide
    Outcome
    DecreaseDiscontinuation due to adverse events
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    145 μg once daily · oral · 12 weeksAs given in this study (human).

    Measurements

    Discontinuation
    5%
    linaclotide 145 μg
    Discontinuation
    6%
    placebo

    Source sentences

    Summary
    AEs resulted in premature discontinuation of 5% and 9% of linaclotide 145 μg and 290 μg patients, respectively, and 6% of placebo patients.
    1 context sentence
    Summary · context
    This Phase 3b, randomized, double-blind, placebo-controlled clinical trial randomized patients to oral linaclotide (145 or 290 μg) or placebo once daily for 12 weeks. Eligible patients met Rome II criteria for chronic constipation upon entry with an average abdominal bloating score ≥5 (self-assessment: 0 10-point numerical rating scale) during the 14-day baseline period.
  9. 09HumanRandomized controlled trialSafety outcome

    In constipation patients with bloating, adverse events caused discontinuation in 9% on linaclotide 290 μg versus 6% on placebo.

    In plain wordsIn constipation patients with bloating, adverse events caused discontinuation in 9% with linaclotide 290 μg versus 6% with placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseDiscontinuation due to adverse events
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Adverse events · Whole body
    Studied dose
    290 μg once daily · oral · 12 weeksAs given in this study (human).

    Measurements

    Discontinuation
    9%
    linaclotide 290 μg
    Discontinuation
    6%
    placebo

    Source sentences

    Summary
    AEs resulted in premature discontinuation of 5% and 9% of linaclotide 145 μg and 290 μg patients, respectively, and 6% of placebo patients.
    1 context sentence
    Summary · context
    This Phase 3b, randomized, double-blind, placebo-controlled clinical trial randomized patients to oral linaclotide (145 or 290 μg) or placebo once daily for 12 weeks. Eligible patients met Rome II criteria for chronic constipation upon entry with an average abdominal bloating score ≥5 (self-assessment: 0 10-point numerical rating scale) during the 14-day baseline period.

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 postedNCT01642914

Safety and Efficacy of Linaclotide in Patients With Chronic Constipation and Prominent Abdominal Bloating

Forest Laboratoriesn = 487Aug 2012 to Aug 2013

Chronic Constipation · Constipation

Trial pageClinicalTrials.govUpdated 26 Apr 2016

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.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. 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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