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Study · Randomized controlled trial · 2022

4 results

The Effect of Acid Suppression Therapy on the Safety and Efficacy of Plecanatide: Analysis of Randomized Phase III Trials.

Moshiree B, Schoenfeld P, Franklin H, Rezaie A

Clinical therapeutics25 Jan 2022

PMID35086735 (opens in a new tab)DOI10.1016/j.clinthera.2021.11.009 (opens in a new tab)PepBankPUB-35086735
Publisher pagePubMedAsk about this study
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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 study4

4 results from studies that gave the peptide. 4 results from people.

  1. 01HumanRandomized controlled trialEfficacy outcome

    In CIC patients using acid suppressors, response was 23.6% with plecanatide 3 mg versus 7.6% with placebo (P = 0.001).

    In plain wordsWith acid suppressors, response was 23.6% with plecanatide 3 mg versus 7.6% with placebo in CIC.

    Peptide
    Plecanatide
    Outcome
    IncreaseDurable overall CSBM response
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    3 mg · 12 weeksAs given in this study (human).

    Measurements

    Durable overall CSBM response rate
    23.6%
    plecanatide 3 mg, with acid suppressors
    Durable overall CSBM response rate
    7.6%
    placebo, with acid suppressors

    Source sentences

    Summary
    Efficacy response rates in patients using acid suppressors were 23.6% with plecanatide 3 mg (P = 0.001 vs placebo), 22.1% with plecanatide 6 mg (P = 0.002), and 7.6% with placebo.
    3 context sentences
    Summary · context
    Data from 2 placebo-controlled, 12-week Phase III trials of plecanatide in CIC were pooled.
    Summary · context
    Patients were randomized to receive placebo, plecanatide 3 mg, or plecanatide 6 mg.
    Summary · context
    Results were stratified by concomitant use or nonuse of acid suppression therapy.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In CIC patients using acid suppressors, response was 22.1% with plecanatide 6 mg versus 7.6% with placebo (P = 0.002).

    In plain wordsWith acid suppressors, response was 22.1% with plecanatide 6 mg versus 7.6% with placebo in CIC.

    Peptide
    Plecanatide
    Outcome
    IncreaseDurable overall CSBM response
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    6 mg · 12 weeksAs given in this study (human).

    Measurements

    Durable overall CSBM response rate
    22.1%
    plecanatide 6 mg, with acid suppressors
    Durable overall CSBM response rate
    7.6%
    placebo, with acid suppressors

    Source sentences

    Summary
    Efficacy response rates in patients using acid suppressors were 23.6% with plecanatide 3 mg (P = 0.001 vs placebo), 22.1% with plecanatide 6 mg (P = 0.002), and 7.6% with placebo.
    3 context sentences
    Summary · context
    Data from 2 placebo-controlled, 12-week Phase III trials of plecanatide in CIC were pooled.
    Summary · context
    Patients were randomized to receive placebo, plecanatide 3 mg, or plecanatide 6 mg.
    Summary · context
    Results were stratified by concomitant use or nonuse of acid suppression therapy.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In CIC patients without acid suppressors, response was 20.4% with plecanatide 3 mg versus 12.1% with placebo (P < 0.001).

    In plain wordsWithout acid suppressors, response was 20.4% with plecanatide 3 mg versus 12.1% with placebo in CIC.

    Peptide
    Plecanatide
    Outcome
    IncreaseDurable overall CSBM response
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    3 mg · 12 weeksAs given in this study (human).

    Measurements

    Durable overall CSBM response rate
    20.4%
    plecanatide 3 mg, without acid suppressors
    Durable overall CSBM response rate
    12.1%
    placebo, without acid suppressors

    Source sentences

    Summary
    Responses were similar in patients not using acid suppressors: 20.4% (plecanatide 3 mg, P < 0.001), 19.6% (plecanatide 6 mg, P < 0.001), and 12.1% (placebo).
    3 context sentences
    Summary · context
    Data from 2 placebo-controlled, 12-week Phase III trials of plecanatide in CIC were pooled.
    Summary · context
    Patients were randomized to receive placebo, plecanatide 3 mg, or plecanatide 6 mg.
    Summary · context
    Results were stratified by concomitant use or nonuse of acid suppression therapy.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In CIC patients without acid suppressors, response was 19.6% with plecanatide 6 mg versus 12.1% with placebo (P < 0.001).

    In plain wordsWithout acid suppressors, response was 19.6% with plecanatide 6 mg versus 12.1% with placebo in CIC.

    Peptide
    Plecanatide
    Outcome
    IncreaseDurable overall CSBM response
    Study

    n: not reported in source

    Comparator
    Placebo
    Analysis
    Primary
    Outcome group
    Bowel Function · Gastrointestinal
    Studied dose
    6 mg · 12 weeksAs given in this study (human).

    Measurements

    Durable overall CSBM response rate
    19.6%
    plecanatide 6 mg, without acid suppressors
    Durable overall CSBM response rate
    12.1%
    placebo, without acid suppressors

    Source sentences

    Summary
    Responses were similar in patients not using acid suppressors: 20.4% (plecanatide 3 mg, P < 0.001), 19.6% (plecanatide 6 mg, P < 0.001), and 12.1% (placebo).
    3 context sentences
    Summary · context
    Data from 2 placebo-controlled, 12-week Phase III trials of plecanatide in CIC were pooled.
    Summary · context
    Patients were randomized to receive placebo, plecanatide 3 mg, or plecanatide 6 mg.
    Summary · context
    Results were stratified by concomitant use or nonuse of acid suppression therapy.

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 postedNCT02122471

12-Week Study of Plecanatide for CIC (The National CIC3 Study)

Bausch Health Americas, Inc.n = 1,410Apr 2014 to Jul 2015

Chronic Idiopathic Constipation

Trial pageClinicalTrials.govUpdated 28 May 2019
CompletedPhase 3Results postedNCT01982240

12-Week Study of Plecanatide for CIC (The CIC3 Study)

Bausch Health Americas, Inc.n = 1,394Nov 2013 to Jun 2015

Chronic Idiopathic Constipation

Trial pageClinicalTrials.govUpdated 26 Dec 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.

  1. Version 2Current

    28 Oct 2026, 02:03 UTC

    Study results updated

  2. Version 1

    27 Oct 2026, 16:37 UTC

    First added · source update from Europe PMC

Subjects

Terms as the source lists them.

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