Ignite Creation Date:
2024-05-05 @ 5:15 PM
Last Modification Date:
2024-10-26 @ 9:29 AM
Study NCT ID:
NCT00417690
Status:
TERMINATED
Last Update Posted:
2008-10-15
First Post:
2007-01-02
Brief Title:
High Dose Oral 4-Aminosalicylic Acid PASER to Control Acute Flares of Mild to Moderate Crohns Disease
Sponsor:
Jacobus Pharmaceutical
Organization:
Jacobus Pharmaceutical
Study Overview
Official Title:
A Prospective Randomized Double-Blind Study of PASER in the Management of Patients Experiencing an Acute Flare of Crohns Disease
Status:
TERMINATED
Status Verified Date:
2008-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Efforts at recruitment have halted as recruitment was poor
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 4 week study is to determine whether PASER an approved delayed-release oral formulation of 4-aminosalicylic acid in doses of 4 grams three times daily for 2 weeks followed by 4 grams twice daily for 2 weeks will resolve an acute flare of ileocecal Crohns disease
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