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

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

Detailed Description
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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.

Official Title
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An Open-Label Extension (OLE), Long-term Safety and Tolerability Study of Plecanatide in Patients With Chronic Idiopathic Constipation (CIC)

Conditions
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Chronic Idiopathic Constipation

Intervention / Treatment
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* Drug: Plecanatide


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 81 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Plecanatide 3.0 mg<br>Plecanatide 3.0 mg, one tablet by mouth daily for 52 weeks | Drug: Plecanatide<br> <br> |
| Experimental: Plecanatide 6.0 mg<br>Plecanatide 6.0 mg, one tablet by mouth daily for 52 weeks | Drug: Plecanatide<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) | 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. | From first dose up to 72 weeks | 
| Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide | Tolerability was evaluated based on number of patients who experienced at least one TEAE leading to discontinuation of the study drug | From first dose up to 72 weeks | 
| Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg) | 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). | From first dose up to 72 weeks | 
| Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute) | 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). | From first dose up to 72 weeks | 
| Summary of Vital Signs at >Day 364 - Body Temperature (°C) | 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). | From first dose up to 72 weeks | 
| Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute) | 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). | From first dose up to 72 weeks | 
| Summary of ECG Results Shift From Baseline at > Day 364 | Baseline was defined as the last non-missing value collected prior to first dose of study drug) | From first dose up to 72 weeks | 
| Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline | 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. | From first dose up to 72 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Summary of Patient Patient Global Assessment (PGA) for Constipation Severity at > Day 364 | 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. | Form first dose up to 72 weeks | 
| Summary of Patient Global Assessment (PGA) for Constipation - Change From Baseline to > Day 364 | 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. | From first dose up to 72 weeks | 
| Summary of Patient Global Assessment (PGA) for Treatment Satisfaction at > Day 364 | 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. | From first dose up to 72 weeks | 
| Summary of Patient Global Assessment (PGA) for Treatment Continuation at End of Treatment | 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 | From first dose up to 72 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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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