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

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ClinicalTrials.gov Identifier: NCT01919697
Recruitment Status : Completed
First Posted : August 9, 2013
Results First Posted : July 2, 2019
Last Update Posted : July 2, 2019
Sponsor:
Collaborator:
Syneos Health
Information provided by (Responsible Party):
Bausch Health Americas, Inc.

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

Condition or disease Intervention/treatment Phase
Chronic Idiopathic Constipation Drug: Plecanatide Phase 3

Detailed Description:

This is an open-label extension study of plecanatide in the treatment of patients with CIC who previously completed Synergy Protocols SP304-20210 and SP304203-00 (The CIC3 Study).

The planned duration of each patient's study participation is up to 411 days, including up to 33 days of screening, 8 study visits over 52 weeks of treatment and a follow-up visit 2 weeks after the last dose of study drug.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2370 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Extension (OLE), Long-term Safety and Tolerability Study of Plecanatide in Patients With Chronic Idiopathic Constipation (CIC)
Study Start Date : August 2013
Actual Primary Completion Date : January 2016
Actual Study Completion Date : March 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation
Drug Information available for: Plecanatide

Arm Intervention/treatment
Experimental: Plecanatide 3.0 mg
Plecanatide 3.0 mg, one tablet by mouth daily for 52 weeks
Drug: Plecanatide
Experimental: Plecanatide 6.0 mg
Plecanatide 6.0 mg, one tablet by mouth daily for 52 weeks
Drug: Plecanatide



Primary Outcome Measures :
  1. Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) [ Time Frame: From first dose up to 72 weeks ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 ]
    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 Outcome Measures :
  1. Summary of Patient Patient Global Assessment (PGA) for Constipation Severity at > Day 364 [ Time Frame: Form first dose up to 72 weeks ]
    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 ]
    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 ]
    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 ]
    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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 81 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01919697


Locations
Show Show 220 study locations
Sponsors and Collaborators
Bausch Health Americas, Inc.
Syneos Health
Investigators
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Principal Investigator: Richard A Krause, MD ClinSearch, LLC
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Bausch Health Americas, Inc.
ClinicalTrials.gov Identifier: NCT01919697    
Other Study ID Numbers: SP304203-01
First Posted: August 9, 2013    Key Record Dates
Results First Posted: July 2, 2019
Last Update Posted: July 2, 2019
Last Verified: June 2019
Keywords provided by Bausch Health Americas, Inc.:
Plecantaide
Chronic Idiopathic Constipation
Chronic
Idiopathic
Constipation
Synergy
CIC
CIC study
CIC OLE
CIC OLE study
OLE
OLE CIC
OLE CIC3
Open label
Open label study
Long term
Long term study
Extension
Extension study
Additional relevant MeSH terms:
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Constipation
Signs and Symptoms, Digestive
Plecanatide
Guanylyl Cyclase C Agonists
Enzyme Activators
Molecular Mechanisms of Pharmacological Action
Gastrointestinal Agents