This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in patients with Chronic Idiopathic Constipation (CIC).
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
2,370
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.
Time frame: 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
Time frame: 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).
Time frame: 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).
Time frame: 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).
Time frame: 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).
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Synergy Research Site
Birmingham, Alabama, United States
Synergy Research Site
Dothan, Alabama, United States
Synergy Research Site
Gulf Shores, Alabama, United States
Synergy Research Site
Huntsville, Alabama, United States
Synergy Research Site
Chandler, Arizona, United States
Synergy Research Site
Phoenix, Arizona, United States
Synergy Research Site
Tempe, Arizona, United States
Synergy Research Site
Tucson, Arizona, United States
Synergy Research Site
Tucson, Arizona, United States
Synergy Research Site
Tucson, Arizona, United States
...and 210 more locations
Time frame: 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)
Time frame: 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.
Time frame: From first dose up to 72 weeks
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.
Time frame: 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.
Time frame: 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.
Time frame: 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
Time frame: From first dose up to 72 weeks