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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03933007
Recruitment Status : Recruiting
First Posted : May 1, 2019
Last Update Posted : December 17, 2019
Sponsor:
Information provided by (Responsible Party):
Assistance Publique - Hôpitaux de Paris

Brief 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.


Condition or disease Intervention/treatment Phase
Gout Flare Drug: Colchicine, Drug: midazolam, Drug: fexofenadine Phase 4

Show Show detailed description

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 88 participants
Intervention Model: Single Group Assignment
Intervention Model Description:

all participants will perform the pharmacokinetic study and take colchicine 1 mg + 0.5 mg 1 hour later, midazolam 1 mg and fexofenadine 120 mg.

A pharmacokinetic study is an interventional study with only one arm.

Masking: None (Open Label)
Masking Description: all participants will perform the pharmacokinetic study and take colchicine 1 mg + 0.5 mg 1 hour later, midazolam 1 mg and fexofenadine 120 mg.
Primary Purpose: Treatment
Official Title: Comparison of Maximum Blood Concentrations of Colchicine Between Responders and Non-responders to Colchicine Treatment During Gout Flare
Actual Study Start Date : September 10, 2019
Actual Primary Completion Date : October 10, 2019
Estimated Study Completion Date : December 1, 2020

Resource links provided by the National Library of Medicine

Genetics Home Reference related topics: Gout
MedlinePlus related topics: Gout

Arm Intervention/treatment
Pharmacokinetic study
all participants will undergo pharmacokinetic study and take colchicine (1.5 mg over 1 hour), midazolam (1 mg) and fexofenadine (120 mg)
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




Primary Outcome Measures :
  1. Maximum plasma concentration of colchicine [ Time Frame: From drug administration to 6 hour post-drug administration ]
    Maximum plasma concentration of colchicine in responders and non-responders to colchicine treatment for gout flare during pharmacokinetic study performed 1 month after flare resolution and before initiation of urate-lowering therapy.


Secondary Outcome Measures :
  1. Maximum Plasma Concentration [Cmax] [ Time Frame: From drug administration to 6 hour post-drug administration ]
    pharmacokinetic parameter of absorption of colchicine

  2. Time needed to reach Cmax [Tmax ] [ Time Frame: From drug administration to 6 hour post-drug administration ]
    pharmacokinetic parameter of absorption of colchicine

  3. Absorption rate constant [Ka] [ Time Frame: From drug administration to 6 hour post-drug administration ]
    pharmacokinetic parameter of absorption of colchicine

  4. Volume of distribution [Vd] [ Time Frame: From drug administration to 6 hour post-drug administration ]
    pharmacokinetic parameter of distribution of colchicine

  5. Area under the curve [AUC] [ Time Frame: From drug administration to 6 hour post-drug administration ]
    pharmacokinetic parameter of distribution of colchicine

  6. Clearance [ Time Frame: From drug administration to 6 hour post-drug administration ]
    pharmacokinetic parameter of elimination of colchicine



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

Patients (> 18 years old) with gout flare defined by following items :

  • Identification of sodium urate crystals in synovial fluid analysis
  • Or gout flare diagnosis according to Nijmegen criteria (score > 8/13)

    • Man (2 pts)
    • History of flare (2 pts)
    • Flare involving first metatarsophalangeal joint (2.5 pts)
    • Maximum of flare within 24h (0.5pt),
    • Redness (1 pt),
    • History of hypertension or cardiovascular diseases (1.5 pts),
    • Serum urate level > 360 µmol/l during flare (3.5 pts)
  • Duration of flare < 48 h
  • Monoarticular involvement

Exclusion Criteria:

  • Hypersensitivity to colchicine, fexofenadine, benzodiazepine or the excipients of these drugs
  • Contra-indication to colchicine : chronic kidney disease stage 4-5, severe hepatic impairment, treatment by macrolide antibiotics
  • Used of pain-killers other than acetaminophen
  • Involvement in another clinical trial with drug administration
  • Illiteracy
  • Pregnant woman or breastfeeding

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03933007


Contacts
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Contact: Hang-Korng EA, PhD, MD 33 1 49 95 88 25 hang-korng.ea@aphp.fr

Locations
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France
Hôpital Lariboisière-Service de Rhumatolologie Recruiting
Paris, France, 75010
Contact: Hang-Korng EA, PhD    01 49 95 88 25    hang-korng.ea@aphp.fr   
Principal Investigator: Hang-Korng EA, PhD, MD         
Sponsors and Collaborators
Assistance Publique - Hôpitaux de Paris
Investigators
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Principal Investigator: Hang-Korng EA, PhD, MD AP-HP - Groupe hospitalier Lariboisière Fernand Widal

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Responsible Party: Assistance Publique - Hôpitaux de Paris
ClinicalTrials.gov Identifier: NCT03933007    
Other Study ID Numbers: P170409J
2018-002542-37 ( EudraCT Number )
First Posted: May 1, 2019    Key Record Dates
Last Update Posted: December 17, 2019
Last Verified: December 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Gout
Arthritis, Gouty
Arthritis
Joint Diseases
Musculoskeletal Diseases
Crystal Arthropathies
Rheumatic Diseases
Purine-Pyrimidine Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases
Fexofenadine
Colchicine
Midazolam
Adjuvants, Anesthesia
Hypnotics and Sedatives
Central Nervous System Depressants
Physiological Effects of Drugs
Anti-Anxiety Agents
Tranquilizing Agents
Psychotropic Drugs
Anesthetics, Intravenous
Anesthetics, General
Anesthetics
GABA Modulators
GABA Agents
Neurotransmitter Agents
Molecular Mechanisms of Pharmacological Action
Gout Suppressants
Antirheumatic Agents