Ignite Creation Date:
2024-05-05 @ 11:21 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004810
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
2000-02-24
Brief Title:
Phase II Placebo-Controlled Study of 4-Aminosalicylic Acid for Ulcerative Colitis
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2001-12
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:
OBJECTIVES
I Assess the safety and efficacy of 4-aminosalicylic acid in patients with mildly to moderately severe ulcerative colitis
I Assess the safety and efficacy of 4-aminosalicylic acid in patients with mildly to moderately severe ulcerative colitis
Detailed Description:
PROTOCOL OUTLINE This is a randomized study Patients are stratified by extent of disease
Patients are randomly assigned to oral 4-aminosalicylic acid 4-ASA or placebo administered daily for 6 weeks Optional 4-ASA is available to all patients for up to 1 year
Concurrent therapy with low-dose sulfasalazine prednisone or equivalent is allowed
Patients are randomly assigned to oral 4-aminosalicylic acid 4-ASA or placebo administered daily for 6 weeks Optional 4-ASA is available to all patients for up to 1 year
Concurrent therapy with low-dose sulfasalazine prednisone or equivalent is allowed
Study Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?:
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| UVT-12012 | None | None | None |