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Trial · Interventional

CompletedPhase 3Results postedRegistry data

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

Short name CIC

NCTNCT02122471 (opens ClinicalTrials.gov in a new tab)Other idSP304203-03
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
1,410 participants (actual)
Sponsor
Bausch Health Americas, Inc. · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Apr 2014
Primary completion
May 2015
Completion
Jul 2015
First posted
24 Apr 2014 (estimated)
Last update posted
28 May 2019
Conditions
Chronic Idiopathic Constipation

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
201420152016
  1. Ph 3

    CIC

    NCT02122471

    Apr 2014 to Jul 2015

Registry summary

Text and fields below are the sponsor's entries at ClinicalTrials.gov, shown as posted.

The purpose of this study is to confirm that the investigational medication, plecanatide, is safe and effective in treating chronic idiopathic constipation.

Interventions

  • PlecanatideDrug
  • PlaceboDrug

Arms3

  • Experimental

    Plecanatide 3.0 mg

    Plecanatide tablets 3.0 mg QD for 12 weeks

  • Placebo comparator

    Placebo

    Matching placebo tablets QD for 12 weeks

  • Experimental

    Plecanatide 6.0 mg

    Plecanatide tablets 6.0 mg QD for 12 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Number of Durable Overall CSBM Responders, Mean Replacement Approach

    Time frame · 12-Week Treatment Period

    Registry description

    The primary efficacy endpoint was measured by the number of durable overall CSBM responders over the 12-week Treatment Period. A durable overall CSBM responder was defined as a weekly CSBM responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 weeks. A CSBM weekly responder was defined as a patient who has ≥ 3 Complete Spontaneous Bowel Movements (CSBMs) per week and an increase from baseline of ≥1 CSBM for that week. A CSBM was a bowel movement that occurred in the absence of laxative use within 24 hours and was associated with the feeling of complete evacuation.

Secondary outcomes(4)

  1. Change From Baseline in CSBMs (CSBMs/Week) Over the 12-week Treatment Period , Mean Replacement Approach

    Time frame · Baseline and 12 weeks

    Registry description

    The change from baseline in the number of Complete Spontaneous Bowel Movements (CSBMs) over the 12-week Treatment Period was analyzed. Baseline was the mean number of CSBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. A CSBM was a bowel movement that occurred in the absence of laxative use within 24 hours and was associated with the feeling of complete evacuation.

  2. Change From Baseline in SBMs (SBMs/Week) Over the 12-week Treatment Period, Mean Replacement Approach

    Time frame · Baseline and 12 weeks

    Registry description

    The change from baseline in the number of Spontaneous Bowel Movement (SBM) over the 12-week Treatment Period was analyzed. Baseline was the mean number of SBMs recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly SBM totals were derived from the daily diary entries reported during the Treatment Period.

  3. Change From Baseline in Average Weekly SBM Stool Consistency Over the 12-week Treatment Period, Mean Replacement Approach

    Time frame · Baseline and 12 weeks

    Registry description

    The change from baseline in the stool consistency score (i.e. BSFS) over the 12-week Treatment Period was analyzed. Baseline was the mean BSFS score recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly mean BSFS score per patient was derived from the BSFS entries reported during the Treatment Period in the Daily Symptom Diary. The stool consistency of each bowel movement (BM) was assessed by patients using the 7-point Bristol Stool Form Scale \[BSFS\] from 1 to 7. 1. = separate hard lumps like nuts (difficult to pass) 2. = sausage shaped but lumpy 3. = like a sausage but with cracks on its surface 4. = like a sausage or snake, smooth and soft 5. = soft blobs with clear-cut edges (passed easily) 6. = fluffy pieces with ragged edges, a mushy stool 7. = watery, no solid pieces (entirely liquid)

  4. Change From Baseline in Average Weekly Straining Score Over the 12-week Treatment Period, Mean Replacement Approach

    Time frame · Baseline and 12 weeks

    Registry description

    The change from baseline in the straining score over the 12-week Treatment Period was analyzed. Baseline was the mean of non-missing straining scores recorded during the 2-week baseline diary assessment period prior to the first dose of study drug. The weekly average straining score was derived from the straining scores reported during the Treatment Period in the Daily Symptom Diary. The severity of straining during bowel movements was assessed on a 5-point Likert scale where 0 = none, 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe.

Posted results

Values are shown as posted at ClinicalTrials.gov, with their units. PepBank has not converted, pooled or compared them.

Primary outcome results

Primary outcomeCount of participants· 12-Week Treatment Period

Number of Durable Overall CSBM Responders, Mean Replacement Approach

GroupValue (Participants)
Placebo57
Plecanatide 3 mg88
Plecanatide 6 mg88
Secondary and other outcome results(4)
Secondary outcomeLeast squares mean· Baseline and 12 weeks

Change From Baseline in CSBMs (CSBMs/Week) Over the 12-week Treatment Period , Mean Replacement Approach

GroupValue (CSBMs per week)Spread
Placebo1.410.138
Plecanatide 3 mg2.340.139
Plecanatide 6 mg2.190.138
Secondary outcomeMean· Baseline and 12 weeks

Change From Baseline in SBMs (SBMs/Week) Over the 12-week Treatment Period, Mean Replacement Approach

GroupValue (SBMs per week)Spread
Placebo1.551.591
Plecanatide 3 mg1.792.084
Plecanatide 6 mg1.631.673
Secondary outcomeMean· Baseline and 12 weeks

Change From Baseline in Average Weekly SBM Stool Consistency Over the 12-week Treatment Period, Mean Replacement Approach

GroupValue (score on a scale)Spread
Placebo2.351.090
Plecanatide 3 mg2.161.036
Plecanatide 6 mg2.271.113
Secondary outcomeMean· Baseline and 12 weeks

Change From Baseline in Average Weekly Straining Score Over the 12-week Treatment Period, Mean Replacement Approach

GroupValue (score on a scale)Spread
Placebo2.420.855
Plecanatide 3 mg2.460.859
Plecanatide 6 mg2.470.888

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
PlaceboMatching placebo tablets QD for 12 weeks–8 / 46615 / 466
Plecanatide 3 mgPlecanatide tablets 3 mg QD for 12 weeks–8 / 46725 / 467
Plecanatide 6 mgPlecanatide tablets 6 mg QD for 12 weeks–4 / 46931 / 469

Each cell reads participants affected / participants at risk, as the registry posted them.

Registry data comes from ClinicalTrials.gov. Study results come from studies, not from the registry. How PepBank works

Studies4

Studies that cite this trial.

Studies with results

4 studies on this page

Indexing hint: Randomized controlled trial · 2023

6 results

Plecanatide for the treatment of chronic idiopathic constipation and irritable bowel syndrome with constipation: Post hoc analyses of placebo-controlled trials in adults with severe constipation.

Cash et al. 2023Neurogastroenterology and motilitycited by 7

PMID 37332239DOI 10.1111/nmo.14632PUB-37332239

Full text at the publisher6 results
Publisher pageSee results (6)

Indexing hint: 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 et al. 2022Clinical therapeutics

PMID 35086735DOI 10.1016/j.clinthera.2021.11.009PUB-35086735

Full text at the publisher4 results
Publisher pageSee results (4)

Indexing hint: Randomized controlled trial · 2020

14 results

Evaluation of Plecanatide for the Treatment of Chronic Idiopathic Constipation and Irritable Bowel Syndrome With Constipation in Patients 65 Years or Older.

Menees et al. 2020Clinical therapeuticscited by 8

PMID 32660770DOI 10.1016/j.clinthera.2020.05.012PUB-32660770

Full text at the publisher14 results
Publisher pageSee results (14)

PubMed tag: none · 2017

9 results

Randomized clinical trial: efficacy and safety of plecanatide in the treatment of chronic idiopathic constipation.

DeMicco et al. 2017Therapeutic advances in gastroenterologycited by 63

PMID 29147135PMC5673020DOI 10.1177/1756283x17734697PUB-29147135

Free to read · publisher termsCC BY-NC9 results
Read at sourceSee results (9)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 80 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male or female aged 18-80, inclusive * Meets modified Rome III criteria for functional chronic idiopathic constipation for at least 3 months with symptom onset for at least 6 months * Completed a colonoscopy in accordance with American Gastroenterological Association (AGA) colon cancer screening guidelines (5 years), with no clinically significant findings * Willing to maintain a stable diet during the study Exclusion Criteria: * Loose stool (mushy) or watery (Bristol score 6 or 7) stool in the absence of any laxative or prohibited medicine for \> 25% of Bowel Movements (BMs) during the 3 months prior to screening visit OR during the 14 day pre-treatment assessment * Active peptic ulcer disease, diabetes or hypertension not adequately treated or not stable * History of cathartic colon, laxative, enema abuse, or ischemic colitis * Fecal impaction within 3 months of screening * Patient has had /has any: diseases or conditions associated with constipation (GI or CNS), structural abnormality of the GI tract or gastric bypass surgery, pelvic floor dysfunction, pseudo-obstruction, active infectious gastritis, diverticulitis, anal fissures or any disease or condition that can affect GI motility or defecation or can be associated with abdominal pain * Unexplained and clinically significant "alarm symptoms" including lower GI bleeding, iron-deficiency anemia, weight loss or systemic signs of infection or colitis * Major surgery, stroke or myocardial infarction (MI) within 60 days of screening * Participated in a previous plecanatide clinical trial

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