Ignite Creation Date:
2024-05-05 @ 5:24 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00441766
Status:
TERMINATED
Last Update Posted:
2012-01-20
First Post:
2007-02-27
Brief Title:
Safety and Efficacy of Oral AGN 203818 for the Relief of Irritable Bowel Syndrome Pain
Sponsor:
Allergan
Organization:
Allergan
Study Overview
Official Title:
None
Status:
TERMINATED
Status Verified Date:
2011-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Study was terminated due to company decision after Part A Part B was never conducted
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study will explore the safety and effectiveness of different doses of AGN 203818 in relieving Irritable Bowel Syndrome pain The study is being conducted in 2 parts Part A enrolled 213 pts dosed with either 3 20 60 mg AGN 203818 or placebo over 4 week treatment duration Part B will enroll 320 pts and dose with either 60 100 160 mg BID AGN 203818 or placebo over 12 week treatment duration
Detailed Description:
None
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