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Study · Non-randomized trial · n = 1,602 · 2014

6 results

Responders vs clinical response: a critical analysis of data from linaclotide phase 3 clinical trials in IBS-C.

Lacy BE, Lembo AJ, Macdougall JE, Shiff SJ, Kurtz CB, Currie MG, Johnston JM

Neurogastroenterology and motility30 Dec 2013Cited by 19 (Europe PMC)

PMID24382134 (opens in a new tab)PMCIDPMC4282394 (opens in a new tab)DOI10.1111/nmo.12264 (opens in a new tab)PepBankPUB-24382134
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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 study6

6 results from studies that gave the peptide. 6 results from people.

  1. 01HumanNon-randomized trialEfficacy outcome

    In pooled IBS-C trials, 34% of linaclotide recipients met the FDA responder endpoint versus 17% of placebo recipients (p < 0.0001).

    In plain wordsIn IBS-C trials, 34% with linaclotide met the FDA responder endpoint versus 17% with placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseFDA responder endpoint
    Study

    n = 1,602

    Comparator
    placebo
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    Dose not stated

    Measurements

    FDA response
    34%
    linaclotide
    FDA response
    17%
    placebo

    Source sentences

    Summary
    1602 IBS-C patients enrolled; 34% of linaclotide-treated and 17% of placebo-treated patients met the FDA Responder Endpoint (p < 0.0001).
    1 context sentence
    Summary · context
    We analyzed pooled IBS-C linaclotide trial data to evaluate clinically significant responses in linaclotide-treated patients who did not meet the FDA responder definition.MethodsPercentages of FDA non-responders reporting improvement in abdominal pain, bowel function and/or global relief me…
  2. 02HumanObservational studyEfficacy outcome

    Among IBS-C FDA nonresponders at week 12, pain was at least somewhat relieved in 63% with linaclotide versus 48% with placebo.

    In plain wordsAmong IBS-C FDA nonresponders at week 12, linaclotide was linked to at least some pain relief in 63% versus 48% with placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseAbdominal pain relief among FDA nonresponders
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    Dose not stated

    Measurements

    Pain relief
    63%
    linaclotide FDA nonresponders
    Pain relief
    48%
    placebo FDA nonresponders

    Source sentences

    Summary
    Among FDA non-responders at week 12, 63% of linaclotide-treated patients reported their abdominal pain was at least somewhat relieved, compared with 48% of placebo-treated patients.
    1 context sentence
    Summary · context
    We analyzed pooled IBS-C linaclotide trial data to evaluate clinically significant responses in linaclotide-treated patients who did not meet the FDA responder definition.MethodsPercentages of FDA non-responders reporting improvement in abdominal pain, bowel function and/or global relief me…
  3. 03HumanObservational studyEfficacy outcome

    Among IBS-C FDA nonresponders at week 12, 62% with linaclotide reported at least somewhat improved stool frequency versus 46% with placebo.

    In plain wordsAmong IBS-C FDA nonresponders at week 12, linaclotide was linked to at least some stool frequency improvement in 62% versus 46% with placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseStool frequency improvement among FDA nonresponders
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    Dose not stated

    Measurements

    Stool frequency improvement
    62%
    linaclotide FDA nonresponders
    Stool frequency improvement
    46%
    placebo FDA nonresponders

    Source sentences

    Summary
    For stool frequency, 62% of linaclotide-treated patients reported that they were at least somewhat improved at week 12, compared with 46% of placebo-treated patients.
    1 context sentence
    Summary · context
    We analyzed pooled IBS-C linaclotide trial data to evaluate clinically significant responses in linaclotide-treated patients who did not meet the FDA responder definition.MethodsPercentages of FDA non-responders reporting improvement in abdominal pain, bowel function and/or global relief me…
  4. 04HumanObservational studyEfficacy outcome

    Among IBS-C FDA nonresponders, 65% with linaclotide reported some IBS symptom relief versus 48% with placebo.

    In plain wordsAmong IBS-C FDA nonresponders, linaclotide was linked to some symptom relief in 65% versus 48% with placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseSome global IBS symptom relief among FDA nonresponders
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    Dose not stated

    Measurements

    Some IBS relief
    65%
    linaclotide
    Some IBS relief
    48%
    placebo

    Source sentences

    Summary
    For global IBS symptoms, 65% of linaclotide-treated patients reported at least some IBS-symptom relief, 43% reported adequate relief of IBS symptoms, and 57% reported being satisfied with linaclotide treatment, vs placebo rates of 48%, 34%, and 41% respectively.
    1 context sentence
    Summary · context
    We analyzed pooled IBS-C linaclotide trial data to evaluate clinically significant responses in linaclotide-treated patients who did not meet the FDA responder definition.MethodsPercentages of FDA non-responders reporting improvement in abdominal pain, bowel function and/or global relief me…
  5. 05HumanObservational studyEfficacy outcome

    Among IBS-C FDA nonresponders, 43% with linaclotide reported adequate IBS symptom relief versus 34% with placebo.

    In plain wordsAmong IBS-C FDA nonresponders, linaclotide was linked to adequate symptom relief in 43% versus 34% with placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseAdequate IBS symptom relief among FDA nonresponders
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    Dose not stated

    Measurements

    Adequate IBS relief
    43%
    linaclotide
    Adequate IBS relief
    34%
    placebo

    Source sentences

    Summary
    For global IBS symptoms, 65% of linaclotide-treated patients reported at least some IBS-symptom relief, 43% reported adequate relief of IBS symptoms, and 57% reported being satisfied with linaclotide treatment, vs placebo rates of 48%, 34%, and 41% respectively.
    1 context sentence
    Summary · context
    We analyzed pooled IBS-C linaclotide trial data to evaluate clinically significant responses in linaclotide-treated patients who did not meet the FDA responder definition.MethodsPercentages of FDA non-responders reporting improvement in abdominal pain, bowel function and/or global relief me…
  6. 06HumanObservational studyEfficacy outcome

    Among IBS-C FDA nonresponders, treatment satisfaction was 57% with linaclotide versus 41% with placebo.

    In plain wordsAmong IBS-C FDA nonresponders, linaclotide was linked to treatment satisfaction in 57% versus 41% with placebo.

    Peptide
    Linaclotide
    Outcome
    IncreaseTreatment satisfaction among FDA nonresponders
    Study

    n: not reported in source

    Comparator
    placebo
    Outcome group
    Gastrointestinal protection · Gastrointestinal
    Studied dose
    Dose not stated

    Measurements

    Treatment satisfaction
    57%
    linaclotide
    Treatment satisfaction
    41%
    placebo

    Source sentences

    Summary
    For global IBS symptoms, 65% of linaclotide-treated patients reported at least some IBS-symptom relief, 43% reported adequate relief of IBS symptoms, and 57% reported being satisfied with linaclotide treatment, vs placebo rates of 48%, 34%, and 41% respectively.
    1 context sentence
    Summary · context
    We analyzed pooled IBS-C linaclotide trial data to evaluate clinically significant responses in linaclotide-treated patients who did not meet the FDA responder definition.MethodsPercentages of FDA non-responders reporting improvement in abdominal pain, bowel function and/or global relief me…

AI wrote and checked these results. AI can make mistakes, so check important results against the source.

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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