E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10018627 |
E.1.2 | Term | Gout |
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E.1.3 | Condition being studied is a rare disease | Yes |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
•To compare the proportion of subjects whose serum uric acid (sUA) level is <6.0 mg/dL following 4 weeks of continuous treatment with RDEA806. |
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E.2.2 | Secondary objectives of the trial |
•To evaluate the proportion of subjects whose sUA levels are <6.0 mg/dL, <5.0 mg/dL and <4.0 mg/dL, at each visit. •To evaluate the absolute and percent reduction from baseline in sUA levels, at each visit. •To evaluate the maximum percent reduction in sUA levels, from baseline during the entire treatment period. •To evaluate percent change in 24-hour urine uric acid level from baseline to Week 4. •To evaluate the percent reduction in sUA levels from baseline, summarized by baseline serum creatinine levels, baseline 24 hour urine uric acid excretion and baseline tophus presence or absence. •To evaluate the safety and tolerability of RDEA806 in subjects with gout. •To evaluate the pharmacokinetics and the pharmacokinetic/pharmacodynamic relationship of RDEA806 and its metabolites in subjects with gout.
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal inclusion criteria |
•Male or female outpatients of either gender, age 18 - 75 yrs of age. •Patient is hyperuricemic: screening serum uric acid ≥8 mg/dL. •Patient meets one or more of the 1997 ARA criteria for the diagnosis of gout. •Patient is willing and able to give informed consent and adhere to visit/protocol schedules (informed consent must be given before the first study procedure is performed, including Washout). •All female subjects of child-bearing potential must agree to use a barrier method of birth control (e.g. condom, diaphragm or cap, with a spermicide). Male subjects must continue contraceptive measures until one month after their last intake of study medication. |
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E.4 | Principal exclusion criteria |
•Consumes more than 14 drinks of alcohol per week. •History or suspicion of drug abuse. •History of kidney stones. •Rheumatoid arthritis or other autoimmune disease. •Confirmed or suspected HIV-1 infection •Malignancy, except treated non-melanomatous skin cancer and cervical dsyplasia •Significant cardiac dysfunction including congestive heart failure (NYCA Class III or IV); myocardial infarction or ventricular tachyarrhythmia within the last 6 months; major conduction abnormailities unless corrected with a cardiac pacemaker; prolonged QTC (> 460 msec). •Uncontrolled hypertension (above 150/95). •Inadequate renal function (serum creatinine >1.5 mg/dL or creatinine clearance < 60 mL/min (by MDRD method). •Hemoglobin < 8 g/dL (males) or < 7 g/dL (females). •ALT, AST , or GGT 2 x ULN •Active peptic ulcer disease requiring treatment. •Requires therapy with any other urate-lowering drug other than the RDEA806 during the study. •Requires long-term use of salicylates (other than daily low dose aspirin ≤ 325 mg/day); thiazide diuretics; losartan; azathioprine; mercaptopurine; theophylline; IV colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole; trimethoprim. •A gout flare at screening that is resolved for less than one week prior to first treatment with study drug (exclusive of chronic synovitis/ arthritis). •Pregnant or breast feeding. •Use of an investigational drug within 4 weeks prior to study drug administration. •Known hypersensitivity or allergy to RDEA806 or colchicine or any components in their formulations. •Diabetes Mellitus requiring treatment •Any other medical or psychological condition which, in the opinion of the investigator, might create undue risk to the subject or interfere with the subject’s ability to comply with the protocol requirements, or to complete the study. •Patients taking greater than 1000 mg/day of Vitamin C
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E.5 End points |
E.5.1 | Primary end point(s) |
The primary efficacy endpoint will be serum uric acid (sUA) level <6.0 mg/dl following 4 weeks of RDEA806 using intent-to-treat (IIT) analysis. |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | No |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | Yes |
E.6.7 | Pharmacodynamic | Yes |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | Yes |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | Yes |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | No |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | Yes |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | Yes |
E.8.2.3 | Other | No |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | Yes |
E.8.5.1 | Number of sites anticipated in the EEA | 5 |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | Yes |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.6.3 | If E.8.6.1 or E.8.6.2 are Yes, specify the regions in which trial sites are planned |
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E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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The last visit of the last subject is the end of the trial. |
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 0 |
E.8.9.1 | In the Member State concerned months | 9 |
E.8.9.1 | In the Member State concerned days | 0 |
E.8.9.2 | In all countries concerned by the trial years | 0 |
E.8.9.2 | In all countries concerned by the trial months | 9 |
E.8.9.2 | In all countries concerned by the trial days | 0 |