drugset / Trial / NCT00506883

MPC-004 for the Treatment of an Acute Gout Flare

NCT00506883 ↗

Phase 3 Completed 185 enrolled Takeda
RandomizedParallel-groupDouble-blindTreatment

Summary

This study is a multicenter, randomized, double-blind, placebo-controlled, parallel group, dose-comparison to determine the efficacy and safety of a standard-dose of colchicine (4.8 mg) versus low-dose colchicine (1.8 mg) or placebo for acute gout flares.

Timeline

Start
2007-04
Primary completion
2007-10
Completion
2007-10

Outcome

Met primary endpoint

paper 9 of 58 patients (15.5%) in the placebo group (P = 0.005 and P = 0.034, respectively, versus placebo). PMID 20131255 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Colchicine Small molecule 1.8 mg Oral
Subject Colchicine Small molecule 4.8 mg Oral

Indications