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Compares treatment options for Gout
Official title Immediate Prescription of a Hypouricemic Treatment, Febuxostat, Compared to Its Delayed Administration
ClinicalTrials.gov ID: NCT05109936
What this study is testing
What is Adenuric?
Adenuric is an investigational medicine, given as an once-daily treatment applied to the skin, being studied as a potential treatment for gout.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- Gout, the most common inflammatory rheumatism in France, is a complication of chronic hyperuricemia (\> 360umol / l). The resulting urate crystals are deposited in many tissues, especially the skeletal or kidneys.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Patients with an attack of gout, diagnosed immediately or less than 5 days old. Gout is defined according to American-European criteria (Appendix 3).
- Attack of gout affecting one (or more) peripheral joint (s) whatever (s) it (s):
- Either a first crisis,
- Either a new attack of a gout not treated with a hypo-uricemic or for which the hypo-uricemic treatment has not been taken for at least 6 months.
- Uricemia ≥ 420 µmol / l, including under a diuretic (dosage carried out within 10 days before inclusion),
You likely can't join if
- Patients under the age of 18,
- Stop taking a hypouricemic agent for less than 6 months,
- Known contraindication to ADENURIC 80 mg film-coated tablet: hypersensitivity to the active substance (febuxostat) or to one of the excipients,
- Renal failure defined by creatinine clearance \<30 ml / min,
- Hepatic disease defined by an increase to more than 2 times the normal of transaminases, alkaline phosphatases, to more than 3 times the normal of...
- Non-weaned alcoholism,
See the full eligibility criteria
- Patients with an attack of gout, diagnosed immediately or less than 5 days old. Gout is defined according to American-European criteria (Appendix 3).
- Attack of gout affecting one (or more) peripheral joint (s) whatever (s) it (s):
- Either a first crisis,
- Either a new attack of a gout not treated with a hypo-uricemic or for which the hypo-uricemic treatment has not been taken for at least 6 months.
- Uricemia ≥ 420 µmol / l, including under a diuretic (dosage carried out within 10 days before inclusion),
- Age ≥ 18 years old,
- Patient with a creatinine clearance ≥ 30 ml / min (dosage carried out within 10 days before inclusion),
- Patient having read and understood the information letter and signed the consent form,
- Affiliation to a social security scheme,
- Woman of childbearing potential with effective contraception according to WHO definition (estrogen-progestins or intrauterine device or tubal ligation for more than 1 month and to be continued for at least 5 weeks after...
- Patients under the age of 18,
- Stop taking a hypouricemic agent for less than 6 months,
- Known contraindication to ADENURIC 80 mg film-coated tablet: hypersensitivity to the active substance (febuxostat) or to one of the excipients,
- Renal failure defined by creatinine clearance \<30 ml / min,
- Hepatic disease defined by an increase to more than 2 times the normal of transaminases, alkaline phosphatases, to more than 3 times the normal of gamma-GT,
- Non-weaned alcoholism,
- Crisis more than 5 days old,
- Patient who has received an organ or marrow transplant,
- Person on Naproxen, mercaptopurine, azathioprine, Glycuronidation inhibitors and inducers, theophylline, macrolides, HMG Co-A reductase inhibitors and / or diuretic in combination with an ACE inhibitor or ARAII,
- Person with rare hereditary disorders of galactose intolerance, lactase deficiency or glucose / galactose malabsorption
- Poor understanding of the project due to neurological disease or lack of French practice,
- Pregnant woman or likely to be in the absence of effective contraception (Women of childbearing age should have a negative urine pregnancy test),
- Breastfeeding woman
- Any history of pre-existing major cardiovascular disease (myocardial infarction, stroke, unstable angina, etc.), metabolic, endocrine, psychiatric or cancerous in uncontrolled development,
- Person deprived of liberty by an administrative or judicial decision,
- Person placed under judicial protection, guardianship or curatorship,
- Participating patient who participated in the month preceding inclusion in another treatment drug trial.
The study team makes the final eligibility decision.
Where it's taking place
- Caen, France
- Cherbourg, France
- Dieppe, France
- Elbeuf, France
- Le Havre, France
- Rouen, France
Compensation & support
Some study costs may be covered.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Caen, France; Cherbourg, France; Dieppe, France; Elbeuf, France; Le Havre, France; Rouen, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.