Ignite Creation Date:
2024-05-05 @ 11:08 AM
Last Modification Date:
2024-10-26 @ 9:04 AM
Study NCT ID:
NCT00004288
Status:
COMPLETED
Last Update Posted:
2005-06-24
First Post:
1999-10-18
Brief Title:
Phase II Pilot Study of Olsalazine for Ankylosing Spondylitis
Sponsor:
National Center for Research Resources NCRR
Organization:
Office of Rare Diseases ORD
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 safety and efficacy of olsalazine a dimer of 5-aminosalicylic acid in men with ankylosing spondylitis unresponsive to nonsteroidal anti-inflammatory drugs and physiotherapy
I Assess the safety and efficacy of olsalazine a dimer of 5-aminosalicylic acid in men with ankylosing spondylitis unresponsive to nonsteroidal anti-inflammatory drugs and physiotherapy
Detailed Description:
PROTOCOL OUTLINE Patients are treated with daily olsalazine The dose is increased each week until the protocol dose is reached
Supplemental acetaminophen is allowed nonsteroidal anti-inflammatory drugs continue unchanged Concurrent sulfasalazine is prohibited
Supplemental acetaminophen is allowed nonsteroidal anti-inflammatory drugs continue unchanged Concurrent sulfasalazine is prohibited
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 |
|---|---|---|---|
| URMC-44 | None | None | None |