Skip to content

Study · Randomized controlled trial · n = 1,276 · 2011

9 results

Two randomized trials of linaclotide for chronic constipation.

Lembo AJ, Schneier HA, Shiff SJ, Kurtz CB, MacDougall JE, Jia XD, Shao JZ, Lavins BJ, Currie MG, Fitch DA, Jeglinski BI, Eng P, Fox SM, Johnston JM

The New England journal of medicine1 Aug 2011Cited by 272 (Europe PMC)

PMID21830967 (opens in a new tab)DOI10.1056/nejmoa1010863 (opens in a new tab)PepBankPUB-21830967
Publisher pagePubMedAsk about this study
Jump to 9 results

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 study9

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

  1. 01HumanRandomized controlled trialEfficacy outcome

    In chronic constipation Trial 303, primary response occurred in 21.2% with linaclotide versus 3.3% with placebo (P<0.01).

    In plain wordsIn chronic constipation Trial 303, linaclotide increased complete bowel movement response versus placebo.

    Peptide
    Linaclotide
    Outcome
    IncreasePrimary CSBM response, Trial 303
    Study

    n: not reported in source

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

    Measurements

    Patients reaching primary CSBM end point
    21.2%
    linaclotide 145 μg once daily, Trial 303
    Patients reaching primary CSBM end point
    3.3%
    placebo, Trial 303

    Source sentences

    Summary
    For Trials 303 and 01, respectively, the primary end point was reached by 21.2% and 16.0% of the patients who received 145 μg of linaclotide and by 19.4% and 21.3% of the patients who received 290 μg of linaclotide, as compared with 3.3% and 6.0% of those who received placebo (P<0.01 for all compari…
    2 context sentences
    Summary · context
    We conducted two randomized, 12-week, multicenter, double-blind, parallel-group, placebo-controlled, dual-dose trials (Trials 303 and 01) involving 1276 patients with chronic constipation.
    Summary · context
    Patients received either placebo or linaclotide, 145 μg or 290 μg, once daily for 12 weeks.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In chronic constipation Trial 01, primary response occurred in 16.0% with linaclotide versus 6.0% with placebo (P<0.01).

    In plain wordsIn chronic constipation Trial 01, linaclotide increased complete bowel movement response versus placebo.

    Peptide
    Linaclotide
    Outcome
    IncreasePrimary CSBM response, Trial 01
    Study

    n: not reported in source

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

    Measurements

    Patients reaching primary CSBM end point
    16%
    linaclotide 145 μg once daily, Trial 01
    Patients reaching primary CSBM end point
    6%
    placebo, Trial 01

    Source sentences

    Summary
    For Trials 303 and 01, respectively, the primary end point was reached by 21.2% and 16.0% of the patients who received 145 μg of linaclotide and by 19.4% and 21.3% of the patients who received 290 μg of linaclotide, as compared with 3.3% and 6.0% of those who received placebo (P<0.01 for all compari…
    2 context sentences
    Summary · context
    We conducted two randomized, 12-week, multicenter, double-blind, parallel-group, placebo-controlled, dual-dose trials (Trials 303 and 01) involving 1276 patients with chronic constipation.
    Summary · context
    Patients received either placebo or linaclotide, 145 μg or 290 μg, once daily for 12 weeks.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In chronic constipation Trial 303, primary response occurred in 19.4% with linaclotide versus 3.3% with placebo (P<0.01).

    In plain wordsIn chronic constipation Trial 303, linaclotide increased complete bowel movement response versus placebo.

    Peptide
    Linaclotide
    Outcome
    IncreasePrimary CSBM response, Trial 303
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Gastrointestinal function · Gastrointestinal
    Studied dose
    290 μg once daily · 12 weeksAs given in this study (human).

    Measurements

    Patients reaching primary CSBM end point
    19.4%
    linaclotide 290 μg once daily, Trial 303
    Patients reaching primary CSBM end point
    3.3%
    placebo, Trial 303

    Source sentences

    Summary
    For Trials 303 and 01, respectively, the primary end point was reached by 21.2% and 16.0% of the patients who received 145 μg of linaclotide and by 19.4% and 21.3% of the patients who received 290 μg of linaclotide, as compared with 3.3% and 6.0% of those who received placebo (P<0.01 for all compari…
    2 context sentences
    Summary · context
    We conducted two randomized, 12-week, multicenter, double-blind, parallel-group, placebo-controlled, dual-dose trials (Trials 303 and 01) involving 1276 patients with chronic constipation.
    Summary · context
    Patients received either placebo or linaclotide, 145 μg or 290 μg, once daily for 12 weeks.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In chronic constipation Trial 01, primary response occurred in 21.3% with linaclotide versus 6.0% with placebo (P<0.01).

    In plain wordsIn chronic constipation Trial 01, linaclotide increased complete bowel movement response versus placebo.

    Peptide
    Linaclotide
    Outcome
    IncreasePrimary CSBM response, Trial 01
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Gastrointestinal function · Gastrointestinal
    Studied dose
    290 μg once daily · 12 weeksAs given in this study (human).

    Measurements

    Patients reaching primary CSBM end point
    21.3%
    linaclotide 290 μg once daily, Trial 01
    Patients reaching primary CSBM end point
    6%
    placebo, Trial 01

    Source sentences

    Summary
    For Trials 303 and 01, respectively, the primary end point was reached by 21.2% and 16.0% of the patients who received 145 μg of linaclotide and by 19.4% and 21.3% of the patients who received 290 μg of linaclotide, as compared with 3.3% and 6.0% of those who received placebo (P<0.01 for all compari…
    2 context sentences
    Summary · context
    We conducted two randomized, 12-week, multicenter, double-blind, parallel-group, placebo-controlled, dual-dose trials (Trials 303 and 01) involving 1276 patients with chronic constipation.
    Summary · context
    Patients received either placebo or linaclotide, 145 μg or 290 μg, once daily for 12 weeks.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In chronic constipation patients, linaclotide improved all secondary endpoints significantly more than placebo.

    In plain wordsIn chronic constipation patients, linaclotide improved secondary endpoints more than placebo.

    Peptide
    Linaclotide
    Outcome
    Direction not reportedSecondary endpoints
    Study

    n: not reported in source

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

    Source sentences

    Summary
    Improvements in all secondary end points were significantly greater in both linaclotide groups than in the placebo groups.
    2 context sentences
    Summary · context
    We conducted two randomized, 12-week, multicenter, double-blind, parallel-group, placebo-controlled, dual-dose trials (Trials 303 and 01) involving 1276 patients with chronic constipation.
    Summary · context
    Patients received either placebo or linaclotide, 145 μg or 290 μg, once daily for 12 weeks.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In chronic constipation patients, linaclotide improved all secondary endpoints significantly more than placebo.

    In plain wordsIn chronic constipation patients, linaclotide improved secondary endpoints more than placebo.

    Peptide
    Linaclotide
    Outcome
    Direction not reportedSecondary endpoints
    Study

    n: not reported in source

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

    Source sentences

    Summary
    Improvements in all secondary end points were significantly greater in both linaclotide groups than in the placebo groups.
    2 context sentences
    Summary · context
    We conducted two randomized, 12-week, multicenter, double-blind, parallel-group, placebo-controlled, dual-dose trials (Trials 303 and 01) involving 1276 patients with chronic constipation.
    Summary · context
    Patients received either placebo or linaclotide, 145 μg or 290 μg, once daily for 12 weeks.
  7. 07HumanRandomized controlled trialSafety outcome

    In chronic constipation patients, adverse event incidence was similar across linaclotide and placebo groups, except for diarrhea.

    In plain wordsIn chronic constipation patients, side effect frequency was similar across linaclotide and placebo groups, except for diarrhea.

    Peptide
    Linaclotide
    Outcome
    Direction not reportedAdverse events except diarrhea
    Study

    n = 1,276

    Comparator
    Placebo
    Outcome group
    Adverse events · Gastrointestinal
    Studied dose
    145 or 290 μg once daily · 12 weeksAs given in this study (human).

    Source sentences

    Summary
    The incidence of adverse events was similar among all study groups, with the exception of diarrhea, which led to discontinuation of treatment in 4.2% of patients in both linaclotide groups.
    2 context sentences
    Summary · context
    We conducted two randomized, 12-week, multicenter, double-blind, parallel-group, placebo-controlled, dual-dose trials (Trials 303 and 01) involving 1276 patients with chronic constipation.
    Summary · context
    Patients received either placebo or linaclotide, 145 μg or 290 μg, once daily for 12 weeks.
  8. 08HumanNon-randomized trialSafety outcome

    In patients with chronic constipation, diarrhea led to treatment discontinuation in 4.2% of patients in the linaclotide 145 μg group.

    In plain wordsIn patients with chronic constipation, diarrhea made 4.2% of patients on linaclotide 145 μg stop treatment.

    Peptide
    Linaclotide
    Outcome
    Direction not reportedDiscontinuation due to diarrhea
    Study

    n: not reported in source

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

    Measurements

    Discontinuation due to diarrhea
    4.2%
    linaclotide 145 μg once daily

    Source sentences

    Summary
    The incidence of adverse events was similar among all study groups, with the exception of diarrhea, which led to discontinuation of treatment in 4.2% of patients in both linaclotide groups.
    2 context sentences
    Summary · context
    We conducted two randomized, 12-week, multicenter, double-blind, parallel-group, placebo-controlled, dual-dose trials (Trials 303 and 01) involving 1276 patients with chronic constipation.
    Summary · context
    Patients received either placebo or linaclotide, 145 μg or 290 μg, once daily for 12 weeks.
  9. 09HumanNon-randomized trialSafety outcome

    In patients with chronic constipation, diarrhea led to treatment discontinuation in 4.2% of patients in the linaclotide 290 μg group.

    In plain wordsIn patients with chronic constipation, diarrhea made 4.2% of patients on linaclotide 290 μg stop treatment.

    Peptide
    Linaclotide
    Outcome
    Direction not reportedDiscontinuation due to diarrhea
    Study

    n: not reported in source

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

    Measurements

    Discontinuation due to diarrhea
    4.2%
    linaclotide 290 μg once daily

    Source sentences

    Summary
    The incidence of adverse events was similar among all study groups, with the exception of diarrhea, which led to discontinuation of treatment in 4.2% of patients in both linaclotide groups.
    2 context sentences
    Summary · context
    We conducted two randomized, 12-week, multicenter, double-blind, parallel-group, placebo-controlled, dual-dose trials (Trials 303 and 01) involving 1276 patients with chronic constipation.
    Summary · context
    Patients received either placebo or linaclotide, 145 μg or 290 μg, once daily for 12 weeks.

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

Registered trials2

Trials this study reports on, or that list this study as a reference. Registry data from ClinicalTrials.gov.

2 trials · 2 completed · 2 with posted results · source ClinicalTrials.gov (opens in a new tab)

CompletedPhase 3Results postedNCT00765882

Phase III, Randomized, Double-Blind, Placebo-Controlled, Trial of Linaclotide Administered to Patients With Chronic Constipation

Forest Laboratoriesn = 633Sept 2008 to Aug 2009

Chronic Constipation

Trial pageClinicalTrials.govUpdated 30 Jan 2013
CompletedPhase 3Results postedNCT00730015

Trial of Linaclotide in Patients With Chronic Constipation

Ironwood Pharmaceuticals, Inc.n = 643Aug 2008 to Oct 2009

Chronic Constipation

Trial pageClinicalTrials.govUpdated 30 Jan 2013

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.

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