Ignite Creation Date:
2025-12-24 @ 11:38 PM
Ignite Modification Date:
2025-12-25 @ 9:28 PM
Study NCT ID:
NCT00317356
Status:
TERMINATED
Last Update Posted:
2021-04-30
First Post:
2006-04-21
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis
Sponsor:
Otsuka Pharmaceutical Co., Ltd.
Organization:
Study Overview
Official Title:
A Dose-finding Study of OPC-6535 in Patients With Active Ulcerative Colitis
Status:
TERMINATED
Status Verified Date:
2021-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Efficacy was not cleared at US study
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 examine the safety and efficacy of OPC-6535 (tetomilast) and to determine its optimal dose by once-daily oral administration at 0, 12.5, 25, or 50 mg for 8 weeks in combination with a fixed oral dose of 5-aminosalicylic acid (5-ASA) in patients with active ulcerative colitis.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
False
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?:
Secondary ID Infos
| Secondary ID | Type | Domain | Link | View |
|---|---|---|---|---|
| JapicCTI-060216 | None | None | View |