Condition: Gout Arthritis · Gout Flare · Gout · Sponsor: Massachusetts General Hospital
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.
This description comes directly from the study's public registry record.
Ana D Fernandes, MA · 617-643-2140 · adfernandes@mgh.harvard.edu
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| Mass General Hospital | Boston, Massachusetts, United States | Recruiting |
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Source record: clinicaltrials.gov/study/NCT07346079