Ignite Creation Date:
2024-05-05 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 9:34 AM
Study NCT ID:
NCT00503243
Status:
COMPLETED
Last Update Posted:
2021-06-11
First Post:
2007-07-16
Brief Title:
Safety and Efficacy of SPD476 Mesalazine Given Twice Daily 24 gDay vs SPD476 Given as a Single Dose 48 gDay in Subjects With Acute Mild to Moderate Ulcerative Colitis
Sponsor:
Shire
Organization:
Takeda
Study Overview
Official Title:
A Phase III Randomized Multi-Centre Double-Blind Parallel Group Placebo-Controlled Study to Evaluate the Safety and Efficacy of SPD476 Mesalazine Given Twice Daily 24 gDay Versus SPD476 Given as a Single Dose 48 gDay in Subjects With Acute Mild to Moderate Ulcerative Colitis
Status:
COMPLETED
Status Verified Date:
2021-06
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 aim of this study was to investigate the safety and efficacy of SPD476 24 gday given twice daily BID ie 12 gday BID and SPD476 48gday given QD compared to placebo in subjects with acute mild to moderate ulcerative colitis
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
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 2004-000733-12 | EUDRACT_NUMBER | None | None |