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Study · Randomized controlled trial · n = 1,762 · 2023

19 results

Influence of Demographic Factors on Clinical Outcomes in Adults With Chronic Idiopathic Constipation Treated With Plecanatide.

Rao SSC, Laitman AP, Miner PB Jr

Clinical and translational gastroenterology1 Jul 2023Cited by 3 (Europe PMC)

PMID37162147 (opens in a new tab)PMCIDPMC10371318 (opens in a new tab)DOI10.14309/ctg.0000000000000598 (opens in a new tab)PepBankPUB-37162147
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Summary

IntroductionChronic idiopathic constipation (CIC) is a common condition that affects some patient groups more often. Demographic/clinical characteristics can differ in presentation and therapeutic response. The impact of these characteristics on plecanatide efficacy/safety was examined.MethodsData from 2 identically designed, randomized, phase 3 trials of adults with CIC receiving 3 mg of plecanatide, 6 mg of plecanatide, or placebo for 12 weeks were analyzed. Subgroups were baseline age, body mass index (BMI), race/ethnicity, and sex/gender. Endpoints included durable overall complete spontaneous bowel movement (CSBM) responder rate, weekly CSBMs and spontaneous bowel movements (SBMs), and adverse events.ResultsOverall (N = 2,639; 3 mg of plecanatide [n = 877]; 6 mg of plecanatide [n = 877]; and placebo [n = 885]), CSBM responder rates were significantly greater with 3 mg of plecanatide and 6 mg of plecanatide vs placebo in subgroups with those younger than 65 years ( P < 0.001), females ( P < 0.001), White individuals ( P < 0.001), and BMI <25 kg/m 2 ( P ≤ 0.004) and 25-30 kg/m 2 ( P < 0.001); as well, for 3 mg: 65 years or older ( P = 0.03), non-White individuals ( P < 0.001), and BMI ≥30 kg/m 2 ( P = 0.02). Improvement from baseline in weekly CSBM and SBM frequency occurred in all subgroups for both plecanatide doses vs placebo ( P ≤ 0.02) at week 12, except those aged 65 years or older for 6 mg of plecanatide. The most common adverse event was diarrhea (3 mg [4.9%]; 6 mg [5.4%]; and placebo [1.3%]).DiscussionPooled data from identically designed CIC trials strengthened the ability to identify meaningful subgroup comparisons regarding plecanatide efficacy and safety.
CC BYText from Europe PMC. Highlighted sentences are the source of results.

Results from this study19

19 results from studies that gave the peptide. 19 results from people.

  1. 01HumanRandomized controlled trialSafety outcome

    Diarrhea occurred in 4.9% with plecanatide 3 mg versus 1.3% with placebo in adults with CIC.

    In plain wordsDiarrhea occurred in 4.9% with plecanatide 3 mg versus 1.3% with placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseDiarrhea
    Study

    n = 1,762

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    3 mg · 12 weeksAs given in this study (human).

    Measurements

    Diarrhea incidence
    4.9%
    plecanatide 3 mg
    Diarrhea incidence
    1.3%
    placebo

    Source sentences

    Summary
    The most common adverse event was diarrhea (3 mg [4.9%]; 6 mg [5.4%]; and placebo [1.3%]).
    2 context sentences
    Summary · context
    Data from 2 identically designed, randomized, phase 3 trials of adults with CIC receiving 3 mg of plecanatide, 6 mg of plecanatide, or placebo for 12 weeks were analyzed.
    Summary · context
    Subgroups were baseline age, body mass index (BMI), race/ethnicity, and sex/gender.
  2. 02HumanRandomized controlled trialEfficacy outcome

    In CIC patients younger than 65 years, plecanatide 3 mg increased CSBM response versus placebo (P < 0.001).

    In plain wordsIn younger CIC patients, plecanatide 3 mg increased complete bowel movement response versus placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseDurable CSBM response below age 65
    Study

    n: not reported in source

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

    Measurements

    P value
    < 0.001 P
    3 mg versus placebo, age <65

    Source sentences

    Summary
    CSBM responder rates were significantly greater with 3 mg of plecanatide and 6 mg of plecanatide vs placebo in subgroups with those younger than 65 years ( P < 0.001), females ( P < 0.001), White individuals ( P < 0.001), and BMI <25 kg/m 2 ( P ≤ 0.004) and 25-30 kg/m 2 ( P < 0.001);
    2 context sentences
    Summary · context
    Data from 2 identically designed, randomized, phase 3 trials of adults with CIC receiving 3 mg of plecanatide, 6 mg of plecanatide, or placebo for 12 weeks were analyzed.
    Summary · context
    Subgroups were baseline age, body mass index (BMI), race/ethnicity, and sex/gender.
  3. 03HumanRandomized controlled trialEfficacy outcome

    In CIC patients younger than 65 years, plecanatide 6 mg increased CSBM response versus placebo (P < 0.001).

    In plain wordsIn younger CIC patients, plecanatide 6 mg increased complete bowel movement response versus placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseDurable CSBM response below age 65
    Study

    n: not reported in source

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

    Measurements

    P value
    < 0.001 P
    6 mg versus placebo, age <65

    Source sentences

    Summary
    CSBM responder rates were significantly greater with 3 mg of plecanatide and 6 mg of plecanatide vs placebo in subgroups with those younger than 65 years ( P < 0.001), females ( P < 0.001), White individuals ( P < 0.001), and BMI <25 kg/m 2 ( P ≤ 0.004) and 25-30 kg/m 2 ( P < 0.001);
    2 context sentences
    Summary · context
    Data from 2 identically designed, randomized, phase 3 trials of adults with CIC receiving 3 mg of plecanatide, 6 mg of plecanatide, or placebo for 12 weeks were analyzed.
    Summary · context
    Subgroups were baseline age, body mass index (BMI), race/ethnicity, and sex/gender.
  4. 04HumanRandomized controlled trialEfficacy outcome

    In females with CIC, plecanatide 3 mg increased CSBM response versus placebo (P < 0.001).

    In plain wordsIn females with CIC, plecanatide 3 mg increased complete bowel movement response versus placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseDurable CSBM response in females
    Study

    n: not reported in source

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

    Measurements

    P value
    < 0.001 P
    3 mg versus placebo, females

    Source sentences

    Summary
    CSBM responder rates were significantly greater with 3 mg of plecanatide and 6 mg of plecanatide vs placebo in subgroups with those younger than 65 years ( P < 0.001), females ( P < 0.001), White individuals ( P < 0.001), and BMI <25 kg/m 2 ( P ≤ 0.004) and 25-30 kg/m 2 ( P < 0.001);
    2 context sentences
    Summary · context
    Data from 2 identically designed, randomized, phase 3 trials of adults with CIC receiving 3 mg of plecanatide, 6 mg of plecanatide, or placebo for 12 weeks were analyzed.
    Summary · context
    Subgroups were baseline age, body mass index (BMI), race/ethnicity, and sex/gender.
  5. 05HumanRandomized controlled trialEfficacy outcome

    In females with CIC, plecanatide 6 mg increased CSBM response versus placebo (P < 0.001).

    In plain wordsIn females with CIC, plecanatide 6 mg increased complete bowel movement response versus placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseDurable CSBM response in females
    Study

    n: not reported in source

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

    Measurements

    P value
    < 0.001 P
    6 mg versus placebo, females

    Source sentences

    Summary
    CSBM responder rates were significantly greater with 3 mg of plecanatide and 6 mg of plecanatide vs placebo in subgroups with those younger than 65 years ( P < 0.001), females ( P < 0.001), White individuals ( P < 0.001), and BMI <25 kg/m 2 ( P ≤ 0.004) and 25-30 kg/m 2 ( P < 0.001);
    2 context sentences
    Summary · context
    Data from 2 identically designed, randomized, phase 3 trials of adults with CIC receiving 3 mg of plecanatide, 6 mg of plecanatide, or placebo for 12 weeks were analyzed.
    Summary · context
    Subgroups were baseline age, body mass index (BMI), race/ethnicity, and sex/gender.
  6. 06HumanRandomized controlled trialEfficacy outcome

    In White individuals with CIC, plecanatide 3 mg increased CSBM response versus placebo (P < 0.001).

    In plain wordsIn White individuals with CIC, plecanatide 3 mg increased complete bowel movement response versus placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseDurable CSBM response in White individuals
    Study

    n: not reported in source

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

    Measurements

    P value
    < 0.001 P
    3 mg versus placebo, White individuals

    Source sentences

    Summary
    CSBM responder rates were significantly greater with 3 mg of plecanatide and 6 mg of plecanatide vs placebo in subgroups with those younger than 65 years ( P < 0.001), females ( P < 0.001), White individuals ( P < 0.001), and BMI <25 kg/m 2 ( P ≤ 0.004) and 25-30 kg/m 2 ( P < 0.001);
    2 context sentences
    Summary · context
    Data from 2 identically designed, randomized, phase 3 trials of adults with CIC receiving 3 mg of plecanatide, 6 mg of plecanatide, or placebo for 12 weeks were analyzed.
    Summary · context
    Subgroups were baseline age, body mass index (BMI), race/ethnicity, and sex/gender.
  7. 07HumanRandomized controlled trialEfficacy outcome

    In White individuals with CIC, plecanatide 6 mg increased CSBM response versus placebo (P < 0.001).

    In plain wordsIn White individuals with CIC, plecanatide 6 mg increased complete bowel movement response versus placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseDurable CSBM response in White individuals
    Study

    n: not reported in source

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

    Measurements

    P value
    < 0.001 P
    6 mg versus placebo, White individuals

    Source sentences

    Summary
    CSBM responder rates were significantly greater with 3 mg of plecanatide and 6 mg of plecanatide vs placebo in subgroups with those younger than 65 years ( P < 0.001), females ( P < 0.001), White individuals ( P < 0.001), and BMI <25 kg/m 2 ( P ≤ 0.004) and 25-30 kg/m 2 ( P < 0.001);
    2 context sentences
    Summary · context
    Data from 2 identically designed, randomized, phase 3 trials of adults with CIC receiving 3 mg of plecanatide, 6 mg of plecanatide, or placebo for 12 weeks were analyzed.
    Summary · context
    Subgroups were baseline age, body mass index (BMI), race/ethnicity, and sex/gender.
  8. 08HumanRandomized controlled trialEfficacy outcome

    In CIC patients with BMI <25 kg/m 2, plecanatide 3 mg increased CSBM response versus placebo (P ≤ 0.004).

    In plain wordsIn CIC patients with BMI <25, plecanatide 3 mg increased complete bowel movement response versus placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseDurable CSBM response with BMI <25
    Study

    n: not reported in source

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

    Measurements

    P value
    ≤ 0.004 P
    3 mg versus placebo, BMI <25

    Source sentences

    Summary
    CSBM responder rates were significantly greater with 3 mg of plecanatide and 6 mg of plecanatide vs placebo in subgroups with those younger than 65 years ( P < 0.001), females ( P < 0.001), White individuals ( P < 0.001), and BMI <25 kg/m 2 ( P ≤ 0.004) and 25-30 kg/m 2 ( P < 0.001);
    2 context sentences
    Summary · context
    Data from 2 identically designed, randomized, phase 3 trials of adults with CIC receiving 3 mg of plecanatide, 6 mg of plecanatide, or placebo for 12 weeks were analyzed.
    Summary · context
    Subgroups were baseline age, body mass index (BMI), race/ethnicity, and sex/gender.
  9. 09HumanRandomized controlled trialEfficacy outcome

    In CIC patients with BMI <25 kg/m 2, plecanatide 6 mg increased CSBM response versus placebo (P ≤ 0.004).

    In plain wordsIn CIC patients with BMI <25, plecanatide 6 mg increased complete bowel movement response versus placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseDurable CSBM response with BMI <25
    Study

    n: not reported in source

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

    Measurements

    P value
    ≤ 0.004 P
    6 mg versus placebo, BMI <25

    Source sentences

    Summary
    CSBM responder rates were significantly greater with 3 mg of plecanatide and 6 mg of plecanatide vs placebo in subgroups with those younger than 65 years ( P < 0.001), females ( P < 0.001), White individuals ( P < 0.001), and BMI <25 kg/m 2 ( P ≤ 0.004) and 25-30 kg/m 2 ( P < 0.001);
    2 context sentences
    Summary · context
    Data from 2 identically designed, randomized, phase 3 trials of adults with CIC receiving 3 mg of plecanatide, 6 mg of plecanatide, or placebo for 12 weeks were analyzed.
    Summary · context
    Subgroups were baseline age, body mass index (BMI), race/ethnicity, and sex/gender.
  10. 10HumanRandomized controlled trialEfficacy outcome

    In CIC patients with BMI 25-30 kg/m 2, plecanatide 3 mg increased CSBM response versus placebo (P < 0.001).

    In plain wordsIn CIC patients with BMI 25-30, plecanatide 3 mg increased complete bowel movement response versus placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseDurable CSBM response with BMI 25-30
    Study

    n: not reported in source

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

    Measurements

    P value
    < 0.001 P
    3 mg versus placebo, BMI 25-30

    Source sentences

    Summary
    CSBM responder rates were significantly greater with 3 mg of plecanatide and 6 mg of plecanatide vs placebo in subgroups with those younger than 65 years ( P < 0.001), females ( P < 0.001), White individuals ( P < 0.001), and BMI <25 kg/m 2 ( P ≤ 0.004) and 25-30 kg/m 2 ( P < 0.001);
    2 context sentences
    Summary · context
    Data from 2 identically designed, randomized, phase 3 trials of adults with CIC receiving 3 mg of plecanatide, 6 mg of plecanatide, or placebo for 12 weeks were analyzed.
    Summary · context
    Subgroups were baseline age, body mass index (BMI), race/ethnicity, and sex/gender.
  11. 11HumanRandomized controlled trialEfficacy outcome

    In CIC patients with BMI 25-30 kg/m 2, plecanatide 6 mg increased CSBM response versus placebo (P < 0.001).

    In plain wordsIn CIC patients with BMI 25-30, plecanatide 6 mg increased complete bowel movement response versus placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseDurable CSBM response with BMI 25-30
    Study

    n: not reported in source

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

    Measurements

    P value
    < 0.001 P
    6 mg versus placebo, BMI 25-30

    Source sentences

    Summary
    CSBM responder rates were significantly greater with 3 mg of plecanatide and 6 mg of plecanatide vs placebo in subgroups with those younger than 65 years ( P < 0.001), females ( P < 0.001), White individuals ( P < 0.001), and BMI <25 kg/m 2 ( P ≤ 0.004) and 25-30 kg/m 2 ( P < 0.001);
    2 context sentences
    Summary · context
    Data from 2 identically designed, randomized, phase 3 trials of adults with CIC receiving 3 mg of plecanatide, 6 mg of plecanatide, or placebo for 12 weeks were analyzed.
    Summary · context
    Subgroups were baseline age, body mass index (BMI), race/ethnicity, and sex/gender.
  12. 12HumanRandomized controlled trialEfficacy outcome

    In CIC patients aged 65 years or older, plecanatide 3 mg increased CSBM response versus placebo (P = 0.03).

    In plain wordsIn older CIC patients, plecanatide 3 mg increased complete bowel movement response versus placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseDurable CSBM response at age 65 or older
    Study

    n: not reported in source

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

    Measurements

    P value
    0.03 P
    3 mg versus placebo, age >=65

    Source sentences

    Summary
    as well, for 3 mg: 65 years or older ( P = 0.03), non-White individuals ( P < 0.001), and BMI ≥30 kg/m 2 ( P = 0.02).
    3 context sentences
    Summary · context
    CSBM responder rates were significantly greater with 3 mg of plecanatide and 6 mg of plecanatide vs placebo in subgroups with those younger than 65 years ( P < 0.001), females ( P < 0.001), White individuals ( P < 0.001), and BMI <25 kg/m 2 ( P ≤ 0.004) and 25-30 kg/m 2 ( P < 0.001);
    Summary · context
    Data from 2 identically designed, randomized, phase 3 trials of adults with CIC receiving 3 mg of plecanatide, 6 mg of plecanatide, or placebo for 12 weeks were analyzed.
    Summary · context
    Subgroups were baseline age, body mass index (BMI), race/ethnicity, and sex/gender.
  13. 13HumanRandomized controlled trialEfficacy outcome

    In non-White individuals with CIC, plecanatide 3 mg increased CSBM response versus placebo (P < 0.001).

    In plain wordsIn non-White individuals with CIC, plecanatide 3 mg increased complete bowel movement response versus placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseDurable CSBM response in non-White individuals
    Study

    n: not reported in source

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

    Measurements

    P value
    < 0.001 P
    3 mg versus placebo, non-White individuals

    Source sentences

    Summary
    as well, for 3 mg: 65 years or older ( P = 0.03), non-White individuals ( P < 0.001), and BMI ≥30 kg/m 2 ( P = 0.02).
    3 context sentences
    Summary · context
    CSBM responder rates were significantly greater with 3 mg of plecanatide and 6 mg of plecanatide vs placebo in subgroups with those younger than 65 years ( P < 0.001), females ( P < 0.001), White individuals ( P < 0.001), and BMI <25 kg/m 2 ( P ≤ 0.004) and 25-30 kg/m 2 ( P < 0.001);
    Summary · context
    Data from 2 identically designed, randomized, phase 3 trials of adults with CIC receiving 3 mg of plecanatide, 6 mg of plecanatide, or placebo for 12 weeks were analyzed.
    Summary · context
    Subgroups were baseline age, body mass index (BMI), race/ethnicity, and sex/gender.
  14. 14HumanRandomized controlled trialEfficacy outcome

    In CIC patients with BMI ≥30 kg/m 2, plecanatide 3 mg increased CSBM response versus placebo (P = 0.02).

    In plain wordsIn CIC patients with BMI ≥30, plecanatide 3 mg increased complete bowel movement response versus placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseDurable CSBM response with BMI ≥30
    Study

    n: not reported in source

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

    Measurements

    P value
    0.02 P
    3 mg versus placebo, BMI >=30

    Source sentences

    Summary
    as well, for 3 mg: 65 years or older ( P = 0.03), non-White individuals ( P < 0.001), and BMI ≥30 kg/m 2 ( P = 0.02).
    3 context sentences
    Summary · context
    CSBM responder rates were significantly greater with 3 mg of plecanatide and 6 mg of plecanatide vs placebo in subgroups with those younger than 65 years ( P < 0.001), females ( P < 0.001), White individuals ( P < 0.001), and BMI <25 kg/m 2 ( P ≤ 0.004) and 25-30 kg/m 2 ( P < 0.001);
    Summary · context
    Data from 2 identically designed, randomized, phase 3 trials of adults with CIC receiving 3 mg of plecanatide, 6 mg of plecanatide, or placebo for 12 weeks were analyzed.
    Summary · context
    Subgroups were baseline age, body mass index (BMI), race/ethnicity, and sex/gender.
  15. 15HumanRandomized controlled trialEfficacy outcome

    At week 12, plecanatide 3 mg improved weekly CSBM frequency versus placebo in all demographic subgroups.

    In plain wordsAt week 12, plecanatide 3 mg improved complete bowel movement frequency versus placebo in all demographic subgroups.

    Peptide
    Plecanatide
    Outcome
    IncreaseWeekly CSBM frequency by subgroup
    Study

    n: not reported in source

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

    Measurements

    P value
    ≤ 0.02 P
    3 mg versus placebo, all subgroups, week 12

    Source sentences

    Summary
    Improvement from baseline in weekly CSBM and SBM frequency occurred in all subgroups for both plecanatide doses vs placebo ( P ≤ 0.02) at week 12, except those aged 65 years or older for 6 mg of plecanatide.
    2 context sentences
    Summary · context
    Data from 2 identically designed, randomized, phase 3 trials of adults with CIC receiving 3 mg of plecanatide, 6 mg of plecanatide, or placebo for 12 weeks were analyzed.
    Summary · context
    Subgroups were baseline age, body mass index (BMI), race/ethnicity, and sex/gender.
  16. 16HumanRandomized controlled trialEfficacy outcome

    At week 12, plecanatide 3 mg improved weekly SBM frequency versus placebo in all demographic subgroups.

    In plain wordsAt week 12, plecanatide 3 mg improved bowel movement frequency versus placebo in all demographic subgroups.

    Peptide
    Plecanatide
    Outcome
    IncreaseWeekly SBM frequency by subgroup
    Study

    n: not reported in source

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

    Measurements

    P value
    ≤ 0.02 P
    3 mg versus placebo, all subgroups, week 12

    Source sentences

    Summary
    Improvement from baseline in weekly CSBM and SBM frequency occurred in all subgroups for both plecanatide doses vs placebo ( P ≤ 0.02) at week 12, except those aged 65 years or older for 6 mg of plecanatide.
    2 context sentences
    Summary · context
    Data from 2 identically designed, randomized, phase 3 trials of adults with CIC receiving 3 mg of plecanatide, 6 mg of plecanatide, or placebo for 12 weeks were analyzed.
    Summary · context
    Subgroups were baseline age, body mass index (BMI), race/ethnicity, and sex/gender.
  17. 17HumanRandomized controlled trialEfficacy outcome

    At week 12, plecanatide 6 mg improved weekly CSBM frequency versus placebo in all subgroups except adults aged 65 years or older.

    In plain wordsAt week 12, plecanatide 6 mg improved complete bowel movement frequency versus placebo, except in the older subgroup.

    Peptide
    Plecanatide
    Outcome
    IncreaseWeekly CSBM frequency by subgroup
    Study

    n: not reported in source

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

    Measurements

    P value
    ≤ 0.02 P
    6 mg versus placebo, all subgroups except age >=65, week 12

    Source sentences

    Summary
    Improvement from baseline in weekly CSBM and SBM frequency occurred in all subgroups for both plecanatide doses vs placebo ( P ≤ 0.02) at week 12, except those aged 65 years or older for 6 mg of plecanatide.
    2 context sentences
    Summary · context
    Data from 2 identically designed, randomized, phase 3 trials of adults with CIC receiving 3 mg of plecanatide, 6 mg of plecanatide, or placebo for 12 weeks were analyzed.
    Summary · context
    Subgroups were baseline age, body mass index (BMI), race/ethnicity, and sex/gender.
  18. 18HumanRandomized controlled trialEfficacy outcome

    At week 12, plecanatide 6 mg improved weekly SBM frequency versus placebo in all subgroups except adults aged 65 years or older.

    In plain wordsAt week 12, plecanatide 6 mg improved bowel movement frequency versus placebo, except in the older subgroup.

    Peptide
    Plecanatide
    Outcome
    IncreaseWeekly SBM frequency by subgroup
    Study

    n: not reported in source

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

    Measurements

    P value
    ≤ 0.02 P
    6 mg versus placebo, all subgroups except age >=65, week 12

    Source sentences

    Summary
    Improvement from baseline in weekly CSBM and SBM frequency occurred in all subgroups for both plecanatide doses vs placebo ( P ≤ 0.02) at week 12, except those aged 65 years or older for 6 mg of plecanatide.
    2 context sentences
    Summary · context
    Data from 2 identically designed, randomized, phase 3 trials of adults with CIC receiving 3 mg of plecanatide, 6 mg of plecanatide, or placebo for 12 weeks were analyzed.
    Summary · context
    Subgroups were baseline age, body mass index (BMI), race/ethnicity, and sex/gender.
  19. 19HumanRandomized controlled trialSafety outcome

    Diarrhea occurred in 5.4% with plecanatide 6 mg versus 1.3% with placebo in adults with CIC.

    In plain wordsDiarrhea occurred in 5.4% with plecanatide 6 mg versus 1.3% with placebo.

    Peptide
    Plecanatide
    Outcome
    IncreaseDiarrhea
    Study

    n: not reported in source

    Comparator
    Placebo
    Outcome group
    Gastrointestinal adverse events · Gastrointestinal
    Studied dose
    6 mg · 12 weeksAs given in this study (human).

    Measurements

    Diarrhea incidence
    5.4%
    plecanatide 6 mg
    Diarrhea incidence
    1.3%
    placebo

    Source sentences

    Summary
    The most common adverse event was diarrhea (3 mg [4.9%]; 6 mg [5.4%]; and placebo [1.3%]).
    2 context sentences
    Summary · context
    Data from 2 identically designed, randomized, phase 3 trials of adults with CIC receiving 3 mg of plecanatide, 6 mg of plecanatide, or placebo for 12 weeks were analyzed.
    Summary · context
    Subgroups were baseline age, body mass index (BMI), race/ethnicity, and sex/gender.

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 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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