Ignite Creation Date:
2024-05-06 @ 9:58 AM
Last Modification Date:
2024-10-26 @ 12:22 PM
Study NCT ID:
NCT03120520
Status:
COMPLETED
Last Update Posted:
2019-10-04
First Post:
2017-04-18
Brief Title:
An Efficacy and Safety Study of Plecanatide in Adolescents 12 to 18 Years of Age With Chronic Idiopathic Constipation
Sponsor:
Bausch Health Americas Inc
Organization:
Bausch Health Americas Inc
Study Overview
Official Title:
A Randomized Double-blind Placebo-controlled 3 Dose Level Parallel Group Study of the Efficacy and Safety of Plecanatide in Adolescents 12 to 18 Years of Age With Chronic Idiopathic Constipation CIC
Status:
COMPLETED
Status Verified Date:
2019-08
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 study of efficacy and safety of Plecanatide in pediatric subjects aged 12 to 18 years diagnosed with Chronic Idiopathic Constipation
Detailed Description:
The purpose of the study is to evaluate efficacy safety and pharmacokinetics PK of oral Plecanatide 05 10 and 15 mg tablets dosed once a day as compared to matching placebo when administered for 8 weeks in adolescents with chronic idiopathic constipation
This study will consist of a 4-week screening period 8 weeks of treatment and a 2-week follow-up The study will assess the effects of Plecanatide on bowel movement frequency and other clinical features of CIC
This study will consist of a 4-week screening period 8 weeks of treatment and a 2-week follow-up The study will assess the effects of Plecanatide on bowel movement frequency and other clinical features of CIC
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None