hyperuricemia and gout MedDRA version: 14.1 Level: PT Classification code 10018627 Term: Gout System Organ Class: 10027433 - Metabolism and nutrition disorders MedDRA version: 14.1 Level: LLT Classification code 10020907 Term: Hyperuricemia System Organ Class: 10027433 - Metabolism and nutrition disorders
Conditions
Interventions
Trade Name: ADENURIC
Product Name: Febuxostat
Pharmaceutical Form: Capsule, hard
INN or Proposed INN: FEBUXOSTAT
CAS Number: 144060-53-7
Concentration unit: mg milligram(s)
Concentration type: equal
C
Sponsors
MENARINI INTERNATIONAL OPERATIONS LUXEMBOURG S.A.
Eligibility
Sex/Gender
All
Inclusion 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 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
Exclusion criteria: Serum creatinine >1.5 mg/dL or calculated creatinine clearance 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary study objective is to determine whether Febuxostat 80 mg, given once a day, is better than Allopurinol 300 mg/die considering the proportion of subjects, at visit 1 (week 4), whose serum urate concentrations will be below 6 mg/dL (357 µmol/L).;Secondary Objective: Secondary objectives are the evaluation of the efficacy of Febuxostat 80 mg, given after a four-week treatment with Allopurinol 300 mg in lowering serum urate concentration below 6 mg/dL at visit 2 (week 8 after randomisation). The evaluation of efficacy of Febuxostat 120 mg, given once a day, after four weeks treatment with Febuxostat 80 mg, versus Febuxostat 80 mg and Allopurinol 300 mg/die considering the proportion of subjects at visit 2 (week 8) whose serum urate concentrations will be below 6 mg/dL (357 µmol/L) and considering the proportion of subjects at visit 6 (week 24), whose last 3 monthly (at week 16, 20 and 24) serum urate concentrations will be below 6 mg/dL (357 µmol/L). The comparison of efficacy of Febuxostat 80 and 120 mg, given once a day versus Allopurinol 300 mg/die by assessment of serum urate concentrations at each post baseline visits (visit 1, 2, 3, 4, 5 and 6). Evaluation of the effect of urate lowering therapy to gout flare incidence during the study. ;Primary end point(s): Percentage of subjects with serum urate levels < 6.0 mg/dL after 4 weeks of treatment (visit 1).;Timepoint(s) of evaluation of this end point: visit 1 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Percentage of subjects, in each treatment group, as defined at visit 1, with the serum urate levels <6.0 mg/dL after 8 weeks of treatment (visit 2). Percentage of subjects, in each treatment group, as defined at visit 2, with the last 3 serum urate levels (at 16, 20 and 24 weeks from the treatment start) < 6.0 mg/dL after 24 weeks of treatment (end of study) overall and within each of the three subgroups of subjects defined by baseline urate concentration (less than 9.0 mg/dL, at least 9.0 mg/dL but less than 10 mg/dL, 10 mg/dL or more). Percentage of subjects with serum urate levels <6.0 mg/dL at each study visit (after 12, 16, 20, 24 weeks of treatment). Mean values and percent reduction from baseline in serum urate levels, at each visit. Percentage of subjects with gout flares during the 24 weeks of treatment. ;Timepoint(s) of evaluation of this end point: See above E.5.2 | — |
Countries
Bulgaria, Greece, Italy, Spain
Contacts
Public ContactElisa Dall'O'
Innopharma Srl
Outcome results
None listed