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Trial · Interventional

CompletedPhase 3Results postedRegistry data

Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)

NCTNCT01919697 (opens ClinicalTrials.gov in a new tab)Other idSP304203-01
Open at ClinicalTrials.govAsk about this trial

Overview

Status
Completed
Phase
Phase 3
Enrollment
2,370 participants (actual)
Sponsor
Bausch Health Americas, Inc. · Industry
Design
Not randomized · Open label (no masking)
Countries
2 countries

United States, Canada

Start
Aug 2013
Primary completion
Jan 2016
Completion
Mar 2016
First posted
9 Aug 2013 (estimated)
Last update posted
2 Jul 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
20132014201520162017
  1. Ph 3

    Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)

    NCT01919697

    Aug 2013 to Mar 2016

Registry summary

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

This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in patients with Chronic Idiopathic Constipation (CIC).

Interventions

  • PlecanatideDrug

Arms2

  • Experimental

    Plecanatide 3.0 mg

    Plecanatide 3.0 mg, one tablet by mouth daily for 52 weeks

  • Experimental

    Plecanatide 6.0 mg

    Plecanatide 6.0 mg, one tablet by mouth daily for 52 weeks

Primary outcomes8

Outcomes the sponsor listed as primary.

  1. Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE)

    Time frame · From first dose up to 72 weeks

    Registry description

    All clinically significant findings upon Physical Examinations of the Safety Population during the treatment period were reported as TEAEs. Safety was evaluated based on number of patients who experienced at least one TEAE.

  2. Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide

    Time frame · From first dose up to 72 weeks

    Registry description

    Tolerability was evaluated based on number of patients who experienced at least one TEAE leading to discontinuation of the study drug

  3. Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg)

    Time frame · From first dose up to 72 weeks

    Registry description

    The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).

  4. Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute)

    Time frame · From first dose up to 72 weeks

    Registry description

    The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).

  5. Summary of Vital Signs at >Day 364 - Body Temperature (°C)

    Time frame · From first dose up to 72 weeks

    Registry description

    The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).

  6. Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute)

    Time frame · From first dose up to 72 weeks

    Registry description

    The vital signs included in the assessments were blood pressure (systolic and diastolic; mmHg), heart rate (beats per minute), body temperature (°C) and respiration rate (breaths per minute).

  7. Summary of ECG Results Shift From Baseline at > Day 364

    Time frame · From first dose up to 72 weeks

    Registry description

    Baseline was defined as the last non-missing value collected prior to first dose of study drug)

  8. Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline

    Time frame · From first dose up to 72 weeks

    Registry description

    Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. The Common Terminology Criteria for Adverse Events (CTCAE), Grades 1 through 5 were used for descriptions of severity for each Adverse Event (AE): Grade 1 - Mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; intervention not indicated; Grade 2 - Moderate; minimal, local or noninvasive intervention indicated; limiting age appropriate instrumental Activities of Daily Living (ADL); Grade 3 - Severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self care ADL; Grade 4 - Life-threatening consequences; urgent intervention indicated; Grade 5 - Death related to AE.

Secondary outcomes(4)

  1. Summary of Patient Patient Global Assessment (PGA) for Constipation Severity at > Day 364

    Time frame · Form first dose up to 72 weeks

    Registry description

    Constipation severity was measured using a 5-point score: 1=None, 2=Mild, 3=Moderate, 4=Severe, 5=Very severe Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study.

  2. Summary of Patient Global Assessment (PGA) for Constipation - Change From Baseline to > Day 364

    Time frame · From first dose up to 72 weeks

    Registry description

    Change of Constipation measured using a 7-point score: 1=Very Much Improved, 2=Much Improved, 3=Minimally Improved, 4=No change, 5=Minimally Worse, 6=Much Worse, 7=Very Much Worse Baseline is defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study.

  3. Summary of Patient Global Assessment (PGA) for Treatment Satisfaction at > Day 364

    Time frame · From first dose up to 72 weeks

    Registry description

    Baseline was defined as the last non-missing value collected prior to first dose of study drug within a given entry into the study. Treatment Satisfaction was measured using a 5-point score: 1=Not At All Satisfied, 2=A Little Satisfied, 3=Moderately Satisfied, 4=Quite Satisfied, 5=Very Satisfied.

  4. Summary of Patient Global Assessment (PGA) for Treatment Continuation at End of Treatment

    Time frame · From first dose up to 72 weeks

    Registry description

    Treatment continuation was measured using 5-point score: 1=Not At All Likely, 2=A Little Likely, 3=Moderately Likely, 4=Quite Likely, 5=Very Likely

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· From first dose up to 72 weeks

Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE)

GroupValue (Participants)
Plecanatide 3 mg123
Plecantide 6 mg620
Primary outcomeCount of participants· From first dose up to 72 weeks

Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide

GroupValue (Participants)
Plecanatide 3 mg14
Plecantide 6 mg111
Primary outcomeMean· From first dose up to 72 weeks

Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg)

GroupValue (mmHg)Spread
Plecanatide 3 mg12113.40
Plecantide 6 mg122.914.11
Primary outcomeMean· From first dose up to 72 weeks

Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute)

GroupValue (beats per minute)Spread
Plecanatide 3 mg71.210.03
Plecantide 6 mg71.99.30
Primary outcomeMean· From first dose up to 72 weeks

Summary of Vital Signs at >Day 364 - Body Temperature (°C)

GroupValue (°C)Spread
Plecanatide 3 mg36.620.329
Plecantide 6 mg36.590.378
Primary outcomeMean· From first dose up to 72 weeks

Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute)

GroupValue (breaths per minute)Spread
Plecanatide 3 mg15.72.03
Plecantide 6 mg16.02.31
Primary outcomeNumber· From first dose up to 72 weeks

Summary of ECG Results Shift From Baseline at > Day 364

GroupValue (participants)
Plecanatide 3 mg27
Plecantide 6 mg42
Primary outcomeNumber· From first dose up to 72 weeks

Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline

GroupValue (participants)
Plecanatide 3 mg192
Plecantide 6 mg1498

Adverse events, as posted

Adverse events as posted: participants affected out of participants at risk, by group
GroupDeathsSerious eventsOther events
Plecanatide 3 mgPlecanatide 3 mg, one tablet by mouth daily for 72 weeks0 / 2248 / 22432 / 224
Plecanatide 6 mgPlecanatide 6 mg, one tablet by mouth daily for 72 weeks1 / 214632 / 2146188 / 2146

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

Studies1

Studies that cite this trial.

Studies with results

1 study on this page

Indexing hint: Clinical trial · 2018

10 results

Safety and tolerability of plecanatide in patients with chronic idiopathic constipation: long-term evidence from an open-label study.

Barish et al. 2018Current medical research and opinioncited by 21

PMID 29343131DOI 10.1080/03007995.2018.1430024PUB-29343131

Full text at the publisher10 results
Publisher pageSee results (10)

Eligibility

Who could join, as posted.

Sex
All
Age
from 18 Years up to 81 Years
Healthy volunteers
Not accepted
Inclusion and exclusion criteria, as posted
Inclusion Criteria: * Patient completed a previous double-blind plecanatide study and was compliant with the study requirements. * Patient is in good health without unstable acute illness or exacerbation of an unstable chronic illness or chronic disease that may affect study assessments, particularly if there has been a significant change to health status since the previous plecanatide study. Exclusion Criteria: * Patient has had major surgery including laparoscopic procedures requiring general anesthesia within 60 days of Day 1. * Patient has a medical history of hepatitis B, hepatitis C or human immunodeficiency virus (HIV) infection. * Patient has taken a protocol-prohibited drug without the appropriate washout period.

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