Ignite Creation Date:
2024-05-06 @ 3:25 AM
Last Modification Date:
2024-10-26 @ 11:33 AM
Study NCT ID:
NCT02287818
Status:
COMPLETED
Last Update Posted:
2022-06-28
First Post:
2014-11-06
Brief Title:
A Study of AC-201 Controlled-Release Tablet CR Tablet in Patients With Gout
Sponsor:
TWi Biotechnology Inc
Organization:
TWi Biotechnology Inc
Study Overview
Official Title:
A RANDOMIZED DOUBLE-BLIND PLACEBO-CONTROLLED TRIAL OF AC-201 IN SUBJECTS WITH GOUT
Status:
COMPLETED
Status Verified Date:
2022-06
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 study is designed to test the urate-lowering effect safety and tolerability of AC-201CR in an initial dosing period followed by the addition of a ULT to test the efficacy and safety of the combination and prophylaxis of gout flares during ULT
Detailed Description:
AC-201CR is a control released formulation of AC-201 that in previous clinical studies showed potential dual effects in both reducing serum uric acid sUA and gout flares The mechanism of action of AC-201 includes the inhibition of the production and activity of caspase-1 and interleukin-1β IL-1β and selective inhibition of re-absorption transporters in the kidney The goal of gout treatment is to reduce serum uric acid sUA concentrations below the urate solubility limit while avoiding acute gout flares However the initiation of urate-lowering therapy ULT increases the occurrence of acute gouty arthritis flares IL-1β plays a key role in mediating this inflammatory response
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