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Trial · Interventional

CompletedPhase 2/3Results postedRegistry data

The Plecanatide Chronic Idiopathic Constipation (CIC) Study

NCTNCT01429987 (opens ClinicalTrials.gov in a new tab)Other idSP304-20210Other idSP-SP30420210

Overview

Status
Completed
Phase
Phase 2/3
Enrollment
951 participants (actual)
Sponsor
Bausch Health Americas, Inc. · Industry
Design
Randomized · Quadruple masking
Countries
1 country

United States

Start
Oct 2011
Primary completion
Dec 2012
Completion
Dec 2012
First posted
7 Sept 2011 (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
201120122013
  1. Ph 2/3

    The Plecanatide Chronic Idiopathic Constipation (CIC) Study

    NCT01429987

    Oct 2011 to Dec 2012

Registry summary

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

This is a randomized, double-blind, placebo controlled, 12 week repeat oral dose, dose ranging study to determine the efficacy and safety of 3 doses of plecanatide compared to placebo in patients with Chronic Idiopathic Constipation (CIC).

Interventions

  • plecanatideDrug
  • PlaceboOther

Arms4

  • Experimental

    plecanatide 0.3 mg

    Subjects receive plecanatide 0.3 mg for 12 consecutive weeks

  • Experimental

    plecanatide 1.0 mg

    Subjects receive plecanatide 1.0 mg for 12 consecutive weeks

  • Experimental

    plecanatide 3.0 mg

    Subjects receive plecanatide 3.0 mg for 12 consecutive weeks

  • Placebo comparator

    Placebo

    Subjects receive placebo for 12 consecutive weeks

Primary outcomes1

Outcomes the sponsor listed as primary.

  1. Overall Responder 9/12 Weeks

    Time frame · 12-Week Treatment Period

    Registry description

    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. A weekly responder will have 3 or more CSBMs and an increase of at least one CSBM from baseline in the same week. An overall responder is a patient who is a weekly responder for at least 9 of the 12 treatment weeks, including at least 3 of the last 4 weeks.

Secondary outcomes(4)
  1. Change From Baseline in 12-week CSBM Weekly Frequency Rate

    Time frame · 12-Week Treatment Period

    Registry description

    The number of Complete Spontaneous Bowel Movements (CSBMs) per week

  2. Change From Baseline in 12-week SBM Weekly Frequency Rate

    Time frame · 12-Week Treatment Period

    Registry description

    The number of Spontaneous Bowl Movements experienced per week.

  3. Change From Baseline in Stool Consistency (BSFS) to Over Treatment Period

    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)

  4. Change From Baseline in 12-week Patient Reported Symptoms Associated With Constipation - Straining Score

    Time frame · 12-Week Treatment Period

    Registry description

    The severity of straining (Straining Score) was reported by the patients using a 11-point scale (0-10) where 0 = none and 10 = the worst

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 outcomeNumber· 12-Week Treatment Period

Overall Responder 9/12 Weeks

GroupValue (% of Overall Responder 9/12 weeks)
Plecanatide 0.3 mg18.6
Plecanatide 1.0 mg16.8
Plecanatide 3.0 mg19.0
Placebo10.7
Secondary and other outcome results(4)
Secondary outcomeLeast squares mean· 12-Week Treatment Period

Change From Baseline in 12-week CSBM Weekly Frequency Rate

GroupValue (CSBMs per week)Spread
Plecanatide 0.3 mg1.600.159
Plecanatide 1.0 mg1.810.157
Plecanatide 3.0 mg2.180.159
Placebo1.090.162
Secondary outcomeLeast squares mean· 12-Week Treatment Period

Change From Baseline in 12-week SBM Weekly Frequency Rate

GroupValue (SBMs per week)Spread
Plecanatide 0.3 mg2.200.190
Plecanatide 1.0 mg2.380.188
Plecanatide 3.0 mg3.000.191
Placebo1.350.194
Secondary outcomeLeast squares mean· 12-Week Treatment Period

Change From Baseline in Stool Consistency (BSFS) to Over Treatment Period

GroupValue (scores on a scale)Spread
Plecanatide 0.3 mg1.280.090
Plecanatide 1.0 mg1.700.090
Plecanatide 3.0 mg1.970.089
Placebo0.870.091
Secondary outcomeLeast squares mean· 12-Week Treatment Period

Change From Baseline in 12-week Patient Reported Symptoms Associated With Constipation - Straining Score

GroupValue (scores on a scale)Spread
Plecanatide 0.3 mg-1.250.142
Plecanatide 1.0 mg-1.460.142
Plecanatide 3.0 mg-1.730.143
Placebo-1.040.144

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Plecanatide 0.3 mgSubjects received plecanatide 0.3 mg orally for 12 consecutive weeks–1 / 23755 / 237
Plecanatide 1.0 mgSubjects received plecanatide 1.0 mg orally for 12 consecutive weeks–1 / 23879 / 238
Plecanatide 3.0 mgSubjects received plecanatide 3.0 mg orally for 12 consecutive weeks–2 / 23792 / 237
PlaceboSubjects received placebo orally for 12 consecutive weeks–5 / 23645 / 236

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 functional chronic idiopathic constipation for at least 3 months with symptom onset for at least 6 months. Note: For this trial, patients with manual maneuvers required for \>25% of defecations will not be eligible for participation. * Less than 3 CSBMs per week at baseline and during pretreatment * Completed a colonoscopy in accordance with medical guidelines as appropriate, with no clinically significant findings * 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 (Bristol score- 6 or 7) 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 treatment period * Patient meets the Rome III criteria for Irritable Bowel Syndrome (IBS-C) * 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: 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 within 60 days of screening.

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