Open-label Extension (OLE) Study of Plecanatide for Chronic Idiopathic Constipation (CIC)
| Status: | Recruiting |
|---|---|
| Conditions: | Constipation |
| Therapuetic Areas: | Gastroenterology |
| Healthy: | No |
| Age Range: | 18 - 81 |
| Updated: | 4/21/2016 |
| Start Date: | August 2013 |
| End Date: | December 2015 |
| Contact: | Laura Barrow, PharmD |
| Email: | lbarrow@synergypharma.com |
| Phone: | 212-297-0020 |
An Open-Label Extension (OLE), Long-term Safety and Tolerability Study of Plecanatide in Patients With Chronic Idiopathic Constipation (CIC)
This is a multi-center, open-label, 52-week safety and tolerability study of plecanatide in
patients with Chronic Idiopathic Constipation (CIC).
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.
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.
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.
We found this trial at
211
sites
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