Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC) (NCT01919697) | Clinical Trial Compass
CompletedPhase 3
Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)
United States, Canada2,370 participantsStarted 2013-08
Plain-language summary
This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in patients with Chronic Idiopathic Constipation (CIC).
Who can participate
Age range
18 Years – 81 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE)
Timeframe: From first dose up to 72 weeks
2
Number of Patients With at Least One Treatment-Emergent Adverse Event (TEAE) Leading to Discontinuation of Plecanatide
Timeframe: From first dose up to 72 weeks
3
Summary of Vital Signs at >Day 364 - Blood Pressure (Systolic and Diastolic; mmHg)
Timeframe: From first dose up to 72 weeks
4
Summary of Vital Signs at >Day 364 - Heart Rate (Beats Per Minute)
Timeframe: From first dose up to 72 weeks
5
Summary of Vital Signs at >Day 364 - Body Temperature (°C)
Timeframe: From first dose up to 72 weeks
6
Summary of Vital Signs at >Day 364 - Respiration Rate (Breaths Per Minute)
Timeframe: From first dose up to 72 weeks
7
Summary of ECG Results Shift From Baseline at > Day 364