Ignite Creation Date:
2024-05-05 @ 11:07 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004423
Status:
COMPLETED
Last Update Posted:
2015-03-25
First Post:
1999-10-18
Brief Title:
Controlled Trial of 4-Aminosalicylic Acid in Patients With Small Bowel Crohns Disease
Sponsor:
University of Vermont
Organization:
FDA Office of Orphan Products Development
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2000-01
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 efficacy and safety of 4-aminosalicylic acid in patients with active Crohns disease of the small bowel
I Assess the efficacy and safety of 4-aminosalicylic acid in patients with active Crohns disease of the small bowel
Detailed Description:
PROTOCOL OUTLINE This is a randomized placebo controlled multicenter study Patients are randomized to receive either oral 4-aminosalicylic acid 4-ASA or placebo twice a day for 12 weeks After 12 weeks patients who improved with 4-ASA and those who received placebo are given the option of receiving 4-ASA for an additional year
Patients who were randomized to receive 4-ASA and continue treatment after 12 weeks are followed every 3 months for 1 year Patients who were randomized to receive placebo and begin 4-ASA therapy after 12 weeks are followed monthly for 3 months then every 3 months for 1 year
Completion date provided represents the completion date of the grant per OOPD records
Patients who were randomized to receive 4-ASA and continue treatment after 12 weeks are followed every 3 months for 1 year Patients who were randomized to receive placebo and begin 4-ASA therapy after 12 weeks are followed monthly for 3 months then every 3 months for 1 year
Completion date provided represents the completion date of the grant per OOPD records
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 |
|---|---|---|---|
| UVTCM-FDR001021 | None | None | None |