EUCTR2012-001858-25-IT
Active, not recruiting
Phase 1
A multicentre randomised, double-blind, parallel group study on the therapeutic efficacy and safety of Febuxostat (taken once daily) and the therapeutic efficacy and safety of Allopurinol on serum urate concentration in subjects suffering from hyperuricemia and gout - GLASS
ConditionsSubjects suffering from hyperuricemia and goutMedDRA version: 14.1 Level: PT Classification code 10018627 Term: Gout System Organ Class: 10027433 - Metabolism and nutrition disordersMedDRA version: 14.1 Level: PT Classification code 10020903 Term: Hyperuricaemia System Organ Class: 10027433 - Metabolism and nutrition disordersTherapeutic area: Diseases [C] - Nutritional and Metabolic Diseases [C18]
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Subjects suffering from hyperuricemia and gout
- Sponsor
- MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.
- Enrollment
- 330
- Status
- Active, not recruiting
- Last Updated
- 6 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Outcomes
Primary Outcomes
Not specified
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