Purified Cortrophin Gel Efficacy and Safety Study of 2 Dose Levels in Patients With Acute Gout Flares
Status:
NOT_YET_RECRUITING
Trial end date:
2027-08-31
Target enrollment:
Participant gender:
Summary
This is a randomized, multicenter, double-blind, single administration study to investigate the efficacy and safety of 2 dosing regimens of Purified Cortrophin Gel in the treatment of an acute gouty arthritis flare.
The study consists of three periods: an optional pre-screening period, a double-blind treatment period, and a 7-day follow-up period.
The treatment period is double-blind, and the patients will be randomized to treatment with 40 U Purified Cortrophin Gel or 80 U Purified Cortrophin Gel in a 1:1 ratio. Purified Cortrophin Gel will be administered once (either subcutaneously or intramuscularly) on the first visit (Day 0; Visit 1) and surveyed after 24 hours (Day 1), 48 hours (Day 2), and 72 hours (Day 3; Visit 2) as well as on Day 7.