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

Phase 1

• Conditions: Subjects suffering from hyperuricemia and gout; MedDRA version: 14.1 Level: PT Classification code 10018627 Term: Gout System Organ Class: 10027433 - Metabolism and nutrition disorders; Therapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]; MedDRA version: 14.1 Level: PT Classification code 10020903 Term: Hyperuricaemia System Organ Class: 10027433 - Metabolism and nutrition disorders

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

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-01-11
• Study Completion: 2015-07-02
• Last Update Posted: 30 June 2019

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Not specified
• Target Recruitment: 330

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 (26 – Appendix 1) • 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: 0
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 400
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 240

Exclusion Criteria

• Serum creatinine >1.5 mg/dL or calculated creatinine clearance < 60 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