At a glance

ClinicalIndex Comparison Record

Phase 3Completed· 185 enrolled

Drug / intervention

High Dose Colchicine (4.8 mg total dose) +2 moredrug

Likely dose

High Dose Colchicine (4.8 mg total dose)from record

Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00506883

NCT00506883Phase 3Completed

Compare CT.gov

A Multicenter, Randomized, Double Blind, Placebo Controlled, Parallel Group, 1 Week, Dose Comparison Study to Evaluate the Efficacy, Safety, and Tolerability of MPC-004 in Patients With an Acute Gout Flare

Takeda·interventional·Posted Jul 25, 2007·Updated Nov 1, 2012

In Brief

A Phase 3 clinical trial evaluating High Dose Colchicine (4.8 mg total dose), Low Dose Colchicine (1.8mg total dose), and 1 other intervention for Gout. Completed, enrolled 185 participants across 83 sites.

Detailed 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.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsGout

CountriesUnited States

Collaborators--

Timeline

Phase 3CompletedFinished

200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartApr 2007

First PostedJul 2007

Primary CompletionOct 2007

TodayJul 2026

First PostedJul 25, 2007

Enrollment StartApr 1, 2007

Primary CompletionOct 1, 2007

TodayJul 2, 2026

Enrollment to primary: 6 monthsPosted 18.9 years ago

Interventions

High Dose Colchicine (4.8 mg total dose)drug

At randomization, patients were given an identical looking blister pack containing (8) over encapsulated colchicine 0.6 mg tablets identical in appearance to placebo capsules. Patients were instructed to take 2 capsules initially (1.2 mg) followed by an additional capsule (0.6 mg) every hour for a total of six additional doses (total colchicine dose 4.8 mg) beginning within 12 hours of onset of a qualifying gout flare as confirmed by calling the gout flare call center.

Low Dose Colchicine (1.8mg total dose)drug

At randomization, patients were given an identical looking blister pack containing (3) over encapsulated colchicine 0.6 mg tablets identical in appearance to placebo capsules and five placebo capsules. Patients were instructed to take 2 capsules initially (0.6 mg x 2) followed by an additional capsule every hour for a total of six additional doses (one active (0.6 mg) and 5 placebo capsules), a total colchicine dose = 1.8 mg) beginning within 12 hours of onset of a qualifying gout flare as confirmed by calling the gout flare call center

Placebo Controlother

At randomization, patients were given an identical looking blister pack containing (8) placebo capsules identical in appearance to the study drug. Patients were instructed to take 2 capsules initially followed by an additional capsule every hour for a total of six additional doses beginning within 12 hours of onset of a qualifying gout flare as confirmed by calling the gout flare call center.