Ignite Creation Date:
2024-05-05 @ 11:30 AM
Last Modification Date:
2024-10-26 @ 9:09 AM
Study NCT ID:
NCT00064454
Status:
COMPLETED
Last Update Posted:
2012-05-10
First Post:
2003-07-08
Brief Title:
FACTS II A Study to Test the Safety and Effectiveness of a New Medication on the Treatment of Active Ulcerative Colitis
Sponsor:
Otsuka Pharmaceutical Development Commercialization Inc
Organization:
Otsuka Pharmaceutical Development Commercialization Inc
Study Overview
Official Title:
FACTS II A Phase 3 Multicenter Randomized Double-blind Placebo-controlled Parallel-arm Study of the Efficacy and Safety of OPC-6535 Tablets in the Treatment of Subjects With Active Ulcerative Colitis
Status:
COMPLETED
Status Verified Date:
2012-05
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of the drug OPC-6535 compared to a placebo in patients with active Ulcerative Colitis
Depending on their response participants will be offered the investigational medication for up to one year after the studys completion at select sites
Depending on their response participants will be offered the investigational medication for up to one year after the studys completion at select sites
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