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Relation Between Blood Concentration of Colchicine and Response to Colchicine Treatment in Gout Flare

NCT03933007 · Status: TERMINATED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 26

Last updated 2024-06-03

No results posted yet for this study

Summary

Gout, secondary to sodium urate crystal deposition, is responsible of recurrent inflammatory painful flares. Efficacy of colchicine which is the first line drug for the treatment and prophylaxis of gout flare varies and only half of treated patients experience good response. This study aims to optimize colchicine prescription for the treatment and prophylaxis of gout flare.

Current data suggest that efficiency of colchicine relies on its maximum blood concentration (Cmax).

In this study, the investigators hypothesize that responders to colchicine treatment have higher colchicine Cmax than non-responder patients following the recommended dose regimen (1 mg then 0.5 mg 1 hour later).

The individual pharmacokinetics (PK) of colchicine remains poorly investigated while the assessment of individual drug metabolisms can be performed.

The hypothesis of this study stands that several factors contribute to the variability of colchicine Cmax. The analysis of individual PK profile and a well-characterized metabolism of colchicine will permit a personalized treatment regimen for the treatment and prophylaxis of gout flares.

Conditions

  • Gout Flare

Interventions

DRUG

Colchicine,

the day of phenotyping assay * Colchicine : 1.5 mg over 1 hour (1 mg + 0.5 mg 1 hour later)

DRUG

midazolam,

Midazolam 1 mg

DRUG

fexofenadine

Fexofenadine 120 mg

Sponsors & Collaborators

  • Assistance Publique - Hôpitaux de Paris

    lead OTHER

Principal Investigators

  • Hang-Korng EA, PhD, MD · AP-HP - Groupe hospitalier Lariboisière Fernand Widal

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-09-10
Primary Completion
2019-10-10
Completion
2024-02-28

Countries

  • France

Study Locations

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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 NCT03933007 on ClinicalTrials.gov