Ignite Creation Date:
2024-05-06 @ 2:11 AM
Last Modification Date:
2024-10-26 @ 11:14 AM
Study NCT ID:
NCT01982240
Status:
COMPLETED
Last Update Posted:
2019-12-26
First Post:
2013-11-05
Brief Title:
12-Week Study of Plecanatide for CIC The CIC3 Study
Sponsor:
Bausch Health Americas Inc
Organization:
Bausch Health Americas Inc
Study Overview
Official Title:
A Randomized 12-Week Double-Blind Placebo-Controlled Study to Assess the Safety and Efficacy of Plecanatide 30 and 60 mg in Patients With Chronic Idiopathic Constipation The CIC3 Study
Status:
COMPLETED
Status Verified Date:
2019-12
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:
The purpose of this study is to confirm that the investigational medication plecanatide is safe and effective in treating chronic idiopathic constipation
Detailed Description:
This is a randomized 12-week double-blind placebo-controlled study in approximately 1350 adult male and female patients with CIC comparing 2 doses of plecanatide to placebo The study will be conducted at approximately 180 clinical study sites in the United States US and Canada The primary objective of the study is to evaluate the efficacy and safety of 30 and 60 mg of plecanatide administered once daily QD for 12 weeks in a population of patients with CIC The study population will include only patients without other causes of constipation or other chronic conditions that could interfere with study assessments Patients may not take laxatives with the exception of the study-provided rescue medication bisacodyl 5mg tablets or a number of prohibited drugs that are known to cause constipation or diarrhea during study participation
There are 6 scheduled study visits including the screening and follow-up visits The planned duration of participation in this study will be 112 days and up to 155 days with washout and all visit windows considered
There are 6 scheduled study visits including the screening and follow-up visits The planned duration of participation in this study will be 112 days and up to 155 days with washout and all visit windows considered
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