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This double blind study was conducted in 54 centres on patients with presumed acute gout comparing the efficacy and safety of low-dose branded colchicine with placebo and high dose, branded colchicine. The high dose was a positive comparator based on a prior small study,1 although likely no rheumatologists utilised this high dose protocol due to its known GI side effects. The primary efficacy outcome was accepted by the FDA, and this trial was pivotal in achieving registration of this branded version of previously available unbranded preparations of colchicine.
A total of 575 patients with a history of clinically assumed (ACR classification criteria) or confirmed gout who had >1 attack in the prior 12 months were randomised in a blinded manner to receive low dose colchicine (1.2 mg followed in 1 h by 0.6 mg with subsequent placebo doses – 1.8 mg total), placebo doses or high-dose colchicine (1.2 mg followed by 0.6 mg every hour for 6 h – 4.8 mg total). Patients were given identically appearing blister packs of medication/placebo at time of screening with instructions as to the timing of self-administration.
When patients felt that they were having a gout flare, they phoned into the ‘Gout Flare Call Center’ (24 h/day) and if the call centre nurse felt that …
Competing interests BFM had consulted once for URL, the sponsor of this study. However, he did not have any role in the study design or conduct.