Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)
Status and phase
Conditions
Treatments
Details and patient eligibility
About
This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in patients with Chronic Idiopathic Constipation (CIC).
Full 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.
Enrollment
Sex
Ages
Volunteers
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.
Trial design
Primary purpose
Allocation
Interventional model
Masking
2,370 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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