A clinical study on the therapeutic efficacy and safety of Febuxostat and Allopurinol on serum urate concentration in subjects suffering from hyperuricemia and gout

Phase 1

• Conditions: hyperuricemia and gout; MedDRA version: 14.1Level: PTClassification code 10018627Term: GoutSystem Organ Class: 10027433 - Metabolism and nutrition disorders; MedDRA version: 14.1Level: LLTClassification code 10020907Term: HyperuricemiaSystem Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]

• Registration Number: EUCTR2012-001858-25-GR
• Lead Sponsor: MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-11-23
• Last Update Posted: 12 December 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 448

Inclusion Criteria

Subjects of both sexes suffering from hyperuricemia who had at least one episode of gout flare in their medical history
Sign and symptoms of gout flare have to be resolved at least 48 hours before enrolment or randomisation
Male or female subjects aged =18 years
Subjects willing and able to give written informed consent
Meeting the preliminary criteria of the American Rheumatism Association for the classification of the acute arthritis of primary gout
Serum uric acid = 8.0 milligrams per decilitre (mg/dL) at baseline
Subject willing to comply with the prophylaxis treatment

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 224
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 224

Exclusion Criteria

Serum creatinine >1.5 mg/dL or calculated creatinine clearance < 60 milliliters per minutes (mL/min)
Pregnancy or lactation
Clinical evidence on screening visit of Ischaemic Heart Disease and/or Congestive Heart Failure
Concurrent therapy with Losartan
Concurrent therapy with urate lowering agents, azathioprine, 6-mercaptopurine, thiazide diuretics, theophylline or medications containing aspirin (>325 mg/day) or other salicylates
Concurrent therapy with colchicine, naproxene, indomethacin if not used for gout flares prophylaxis
Body Mass Index (BMI) >50 kilogram per square meter (kg/m²)
A history or presence of xanthinuria, active liver disease or hepatic dysfunction judged clinically relevant in the opinion of the Investigator
Other concurrent severe diseases (cancer, AIDS, thyroid disease etc.) judged clinically relevant in the opinion of the Investigator
Subjects with AST and ALT and total bilirubin more than 1.5 x Upper Normal Limit
Positive history for organ transplantation
Dementia, psychosis, alcoholism (> 350 g ethanol/week) or chronic abuse of medicines, drugs or psychoactive substances
Introduction of concurrent therapies among those not permitted and which cannot be suspended without harm to the subject
Hypersensitivity or contraindications to use of the product under study
Participation in other pharmacological clinical trials in the previous 4 months
Conditions which in the Investigator’s opinion may interfere with the study’s execution or due to which the subject should not participate for safety reasons
Risk of low subject cooperation
Females of childbearing potential not using adequate contraceptive precautions such as implants, injectables, combined oral contraceptives, intrauterine devices, sexual abstinence or vasectomised partner
Lactose intolerance

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified