An Open-Label Extension (OLE), Long-term Safety and Tolerability Study of Plecanatide in Patients With Chronic Idiopathic Constipation (CIC)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 2,370
- 试验地点
- 1
- 主要终点
- Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE)
研究概览
简要总结
This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in patients with Chronic Idiopathic Constipation (CIC).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 81 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Patient has had major surgery including laparoscopic procedures requiring general anesthesia within 60 days of Day
- •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.
研究组 & 干预措施
Plecanatide 3.0 mg
Plecanatide 3.0 mg, one tablet by mouth daily for 52 weeks
干预措施: Plecanatide (Drug)
Plecanatide 6.0 mg
Plecanatide 6.0 mg, one tablet by mouth daily for 52 weeks
干预措施: Plecanatide (Drug)
结局指标
主要结局
Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE)
时间窗: 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.
Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide
时间窗: 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
Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg)
时间窗: 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).
Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute)
时间窗: 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).
Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute)
时间窗: 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).
Summary of Treatment-Emergent Laboratory Abnormalities With At Least a 1-grade Shift From Baseline
时间窗: 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.
Summary of Vital Signs at >Day 364 - Body Temperature (°C)
时间窗: 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).
Summary of ECG Results Shift From Baseline at > Day 364
时间窗: From first dose up to 72 weeks
Baseline was defined as the last non-missing value collected prior to first dose of study drug)
次要结局
- Summary of Patient Patient Global Assessment (PGA) for Constipation Severity at > Day 364(Form first dose up to 72 weeks)
- Summary of Patient Global Assessment (PGA) for Constipation - Change From Baseline to > Day 364(From first dose up to 72 weeks)
- Summary of Patient Global Assessment (PGA) for Treatment Satisfaction at > Day 364(From first dose up to 72 weeks)
- Summary of Patient Global Assessment (PGA) for Treatment Continuation at End of Treatment(From first dose up to 72 weeks)