Ignite Creation Date:
2024-05-06 @ 1:51 AM
Last Modification Date:
2024-10-26 @ 11:11 AM
Study NCT ID:
NCT01919697
Status:
COMPLETED
Last Update Posted:
2019-07-02
First Post:
2013-08-07
Brief Title:
Open-label Extension OLE Study of Plecanatide for Chronic Idiopathic Constipation CIC
Sponsor:
Bausch Health Americas Inc
Organization:
Bausch Health Americas Inc
Study Overview
Official Title:
An Open-Label Extension OLE Long-term Safety and Tolerability Study of Plecanatide in Patients With Chronic Idiopathic Constipation CIC
Status:
COMPLETED
Status Verified Date:
2019-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is a multi-center open-label 52-week safety and tolerability study of plecanatide in patients with Chronic Idiopathic Constipation CIC
Detailed 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 patients 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
The planned duration of each patients 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None