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Trial · Interventional

CompletedPhase 2Results postedRegistry data

The Plecanatide Irritable Bowel Syndrome With Constipation Study (IBS-C)

Short name CIBS

NCTNCT01722318 (opens ClinicalTrials.gov in a new tab)Other idSP304-20212
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 2
Enrollment
428 participants (actual)
Sponsor
Bausch Health Americas, Inc. · Industry
Design
Randomized · Triple masking
Countries
1 country

United States

Start
Nov 2012
Primary completion
Apr 2014
Completion
Oct 2014
First posted
6 Nov 2012 (estimated)
Last update posted
28 May 2019
Conditions
Irritable Bowel Syndrome Characterized by Constipation

Timeline

1 trial · 1 completed · 1 with posted results

  • Completed
  • Ongoing
  • Not yet recruiting
  • Stopped
  • Estimated dates (est.)
  • Results posted
2012201320142015
  1. Ph 2

    CIBS

    NCT01722318

    Nov 2012 to Oct 2014

Registry summary

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

This is a randomized, 12-week, double-blind, placebo-controlled, dose-ranging study in patients with IBS-C.

Interventions

  • PlecanatideDrug
  • PlaceboDrug

Arms5

  • Active comparator

    Plecanatide 0.3mg

    Plecanatide 0.3mg, one tablet by mouth daily for 12 weeks

  • Active comparator

    Plecanatide 1.0mg

    Plecanatide 1.0mg one tablet by mouth daily for 12 weeks

  • Active comparator

    Plecanatide 3.0mg

    Plecanatide 3.0mg, one tablet by mouth daily for 12 weeks

  • Active comparator

    Plecanatide 9.0mg

    Plecanatide 9.0mg, one tablet by mouth daily for 12 weeks

  • Placebo comparator

    Placebo

    Placebo, one tablet by mouth daily for 12 weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Change From Baseline in Weekly CSBMs Frequency Over the 12-Week Treatment Period (mITT Population)

    Time frame · 12 weeks Treatment Period

    Registry description

    The primary efficacy endpoint was the change from baseline in the weekly CSBM frequency (CSBMs per week minus CSBMs per week at baseline) over a 12-week Treatment Period. A Complete Spontaneous Bowel Movement (CSBM) is a Bowel Movement (BM) that occurs in the absence of laxative use within 24 hours of the BM and the patient reports a feeling of complete evacuation.

Secondary outcomes(3)

  1. Change From Baseline in Abdominal Pain Intensity Scores Over 12-Week Treatment Period (mITT Population)

    Time frame · 12-Week Treatment Period

    Registry description

    Abdominal Pain was assessed in the patient's daily response on a scale of 0 to 10 where 0 is did not experience the symptom at all and 10 is experienced the worst.

  2. Change From Baseline in Stool Consistency (BSFS) Over 12-Week Treatment Period (mITT Population)

    Time frame · 12-Week Treatment Period

    Registry description

    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)

  3. Change From Baseline in Straining Scores Over 12-Week Treatment Period (mITT Population)

    Time frame · 12-Week Treatment Period

    Registry description

    The severity of straining (Straining Score) was rated by the patients using a 11-point scale (0-10) where 0 = none and 10 = 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 outcomeLeast squares mean· 12 weeks Treatment Period

Change From Baseline in Weekly CSBMs Frequency Over the 12-Week Treatment Period (mITT Population)

GroupValue (CSBMs per week)Spread
Plecanatide 0.3mg1.280.260
Plecanatide 1.0mg2.120.265
Plecanatide 3.0mg2.740.260
Plecanatide 9.0mg2.440.262
Placebo1.270.260
Secondary and other outcome results(3)
Secondary outcomeLeast squares mean· 12-Week Treatment Period

Change From Baseline in Abdominal Pain Intensity Scores Over 12-Week Treatment Period (mITT Population)

GroupValue (scores on a scale)Spread
Plecanatide 0.3mg-1.50.20
Plecanatide 1.0mg-1.50.20
Plecanatide 3.0mg-2.00.20
Plecanatide 9.0mg-1.80.20
Placebo-1.40.20
Secondary outcomeLeast squares mean· 12-Week Treatment Period

Change From Baseline in Stool Consistency (BSFS) Over 12-Week Treatment Period (mITT Population)

GroupValue (scores on a scale)Spread
Plecanatide 0.3mg1.630.143
Plecanatide 1.0mg1.810.144
Plecanatide 3.0mg2.490.143
Plecanatide 9.0mg2.240.145
Placebo1.010.143
Secondary outcomeLeast squares mean· 12-Week Treatment Period

Change From Baseline in Straining Scores Over 12-Week Treatment Period (mITT Population)

GroupValue (score on a scale)Spread
Plecanatide 0.3mg-1.70.23
Plecanatide 1.0mg-1.50.23
Plecanatide 3.0mg-2.20.23
Plecanatide 9.0mg-2.10.24
Placebo-1.30.23

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Plecanatide 0.3mgPlecanatide 0.3mg, one tablet by mouth daily for 12 weeks Plecanatide–1 / 8518 / 85
Plecanatide 1.0mgPlecanatide 1.0mg one tablet by mouth daily for 12 weeks Plecanatide–0 / 8529 / 85
Plecanatide 3.0mgPlecanatide 3.0mg, one tablet by mouth daily for 12 weeks Plecanatide–1 / 8619 / 86
Plecanatide 9.0mgPlecanatide 9.0mg, one tablet by mouth daily for 12 weeks Plecanatide–2 / 8531 / 85
PlaceboPlacebo, one tablet by mouth daily for 12 weeks Placebo–0 / 8612 / 86

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

Studies0

Studies that cite this trial.

No study cites this trial.

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 75 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Male or female aged 18-75, inclusive * Body Mass Index = 18-35 kg/m2, inclusive * Meets modified Rome III criteria for irritable bowel syndrome with constipation which includes abdominal pain or discomfort for at least 3 days/month in the last 3 months with symptom onset for at least 6 months. * Less than 3 CSBMs and less than 6 SBMs per week during the last 3 months. * Hard or lumpy stools ≥ 25 % of defecations * Patient has average abdominal pain intensity scores ≥ 3 (scale 0-10)for the combined 2 week pre-treatment period * Patient is willing to discontinue use of supplemental fiber, laxatives, prescription and nonprescription medications, herbal or dietary supplements intended to treat constipation during the screening, pre-treatment, treatment and 2-week post-treatment periods * Willing to maintain a stable diet during the study. * Patients with hemorrhoids and/or diverticulosis (NOT diverticulitis) CAN be entered into the study. Exclusion Criteria: * Loose stool (mushy) or watery stool in the absence of any laxative or prohibited medicine for \> 25% of BMs during the 3 months prior to screening visit OR during the 14 day pre-treatment period * Patient has diarrhea-predominant or mixed ( diarrhea and constipation cycling or diarrhea and normal cycling) IBS. * Active peptic ulcer disease 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: 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 within 60 days of screening.

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