MedTrace Logo

Efficacy and Safety of Colchicine for the Prevention of Gout Flares During the Initiation of Allopurinol

NCT01451645 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 82

Last updated 2014-05-12

Study results available
· View outcomes & findings →

Summary

The purpose of this study is to determine if once-daily treatment with colchicine, compared to placebo, is effective in preventing gout flares in patients who are initiating therapy with allopurinol.

Conditions

  • Intercritical Gout

Interventions

DRUG

Colchicine (Colcrys®)

daily 0.6 mg colchicine dosing for 16 weeks

DRUG

placebo

daily placebo dosing for 16 weeks

DRUG

allopurinol

background therapy

Sponsors & Collaborators

Principal Investigators

  • Clinical Trial Management · Regeneron Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2012-08-31
Completion
2012-09-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01451645 on ClinicalTrials.gov