Gout Dose Response Study
5 de febrero de 2014 actualizado por: Ardea Biosciences, Inc.
Randomized, Double-Blind, Multicenter, Placebo-Controlled, Safety and Efficacy Study of RDEA594 Versus Placebo in the Treatment of Hyperuricemia in Patients With Gout
To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28 days of dosing by treatment group.
Descripción general del estudio
Tipo de estudio
Intervencionista
Inscripción (Actual)
123
Fase
- Fase 2
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Ubicaciones de estudio
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Goch, Alemania, 47574
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Hamburg, Alemania, 22143
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Nuremberg, Alemania, 90402
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Pleven, Bulgaria, 5800
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Plovdiv, Bulgaria, 4002
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Plovidv, Bulgaria, 4002
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Sofia, Bulgaria, 1233
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Sofia, Bulgaria, 1709
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Varna, Bulgaria, 9010
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British Columbia
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Coquitlam, British Columbia, Canadá, V3K 3P4
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Kelowna, British Columbia, Canadá, V1Y8E7
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Ontario
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Thornhill, Ontario, Canadá, L4J6W6
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Toronto, Ontario, Canadá, M9W 4L6
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Quebec
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Mirabel, Quebec, Canadá, J7J 2K8
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California
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Los Angeles, California, Estados Unidos, 90017
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Florida
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DeLand, Florida, Estados Unidos, 32720
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North Carolina
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Winston-Salem, North Carolina, Estados Unidos, 27103
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Tennessee
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Jackson, Tennessee, Estados Unidos, 38305
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Tbilisi, Georgia, 0186
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Tbilisi, Georgia, 0102
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Elblag, Polonia, 82-300
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Lodz, Polonia, 90-153
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Lublin, Polonia, 20-607
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Poznan, Polonia, 61-289
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Radom, Polonia, 26-610
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Wroclaw, Polonia, 53-025
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Bruntal, República Checa, 792 01
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Prague, República Checa, 140 00
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Prague, República Checa, 148 00
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
18 años a 75 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Male or post-menopausal or surgically sterile female.
- 18 - 75 years of age.
- Hyperuricemic (i.e., screening sUA ≥8 mg/dL).
- Meets criteria for the diagnosis of gout as per the American Rheumatism Association (ARA) Criteria for the Classification of Acute Arthritis of Primary Gout.
- 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).
- Subjects entering the optional Extension Period must have successfully completed the Double-Blind Treatment Period and Follow-up Period within approximately 4 months and must not have experienced any serious adverse events considered possibly related to study drug.
Exclusion Criteria:
- Classified as an overproducer of urine urate (Cur > 6.0 ml/min/1.73 m2 24- hour urine).
- Consumes more than 14 drinks of alcohol per week (e.g., 1 drink = 5 oz [150 ml] of wine, 12 oz [360 ml] of beer, or 1.5 oz [45 ml] of hard liquor).
- History or suspicion of drug abuse.
- Documented history of or suspicion of kidney stones.
- History of rheumatoid arthritis or other autoimmune disease.
- Confirmed (positive serology to HIV1 and HIV 2) or suspected HIV infection.
- Positive serology to HCV antibodies (Abs), and/or hepatitis B surface antigen (HBsAg).
- History of malignancy, except treated non-melanomatous skin cancer or cervical dysplasia.
- History of cardiac abnormalities, including abnormal and clinically relevant ECG changes such as bradycardia (sinus rate <45 bpm), complete left bundle branch block (LBBB), second or third degree heart block, intraventricular conduction delay with QRS duration >120 msec, symptomatic or asymptomatic arrhythmias with the exception of sinus arrhythmia, evidence of ventricular pre-excitation, frequent palpitations or syncopal episodes, heart failure, hypokalemia, family history of Long QT Syndrome, and/or family history of sudden death in an otherwise healthy individual between the ages of 1 and 30 years.
- Any condition predisposing them to QT prolongation including pathological Q-wave (defined as Q-wave >40 msec or depth > 0.4-0.5 mV).
- Any use of a concomitant medication that prolong the QT/QTc interval within the 14 days prior to Baseline (Day 0)
- QT interval corrected for heart rate according to Fridericia (QTcF) > 450 msec at Screening or pre-dose at Baseline (Day 0)
- Uncontrolled hypertension (above 150/95)
- Inadequate renal function
- Hemoglobin < 10 g/dL (males) or < 9 g/dL (females)
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 2.5 x upper limit of normal (ULN)
- Gamma glutamyl transferase (GGT) > 3 x ULN
- Active peptic ulcer disease requiring treatment
- History of xanthinuria, active liver disease, or hepatic dysfunction.
- Requires therapy with any other urate-lowering medication, other than the study medication.
- Requires long-term use of salicylates; diuretics; azathioprine; mercaptopurine; theophylline; intravenous colchicine; cyclosporine; cyclophosphamide; pyrazinamide; sulfamethoxazole; or trimethoprim
- Taking medications known as enzyme inducers
- Receiving a strong or moderate inhibitor of CYP3A4 or a P-gp inhibitor within 1 month prior to study drug dosing
- Gout flare at screening that is resolved for less than one week prior to the first treatment with study medication (exclusive of chronic synovitis/ arthritis)
- Female of childbearing potential
- Received an investigational medication within 4 weeks prior to study medication administration
- Previously participated in a clinical study involving RDEA806 or RDEA594.
- Known hypersensitivity or allergy to RDEA594 or colchicine or any components in their formulations.
- Body mass index (BMI) >40 kg/m2.
- Taking greater than 1000 mg/day of Vitamin C.
- Any other medical or psychological condition, which in the opinion of the Investigator and/or Medical Monitor, 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.
- Inadequate renal function after completing the Double-Blind Treatment period prior to entering Extension Period.
- Requiring treatment with prohibited medications noted in exclusion criteria numbers 20-23 after completing the Double-Blind Treatment Period prior to entering the Extension Period.
- Clinically relevant medical event as determined by the investigator in consultation with medical monitor prior to entering the Extension Period.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Cuadruplicar
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
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Experimental: RDEA594 200 mg qd for 28 days
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Uricosuric agent for the treatment of gout
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Experimental: RDEA594 200 mg, 400 mg
RDEA594 200 mg qd for 7 days followed by 400 mg qd for 21 days
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Uricosuric agent for the treatment of gout
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Experimental: RDEA594 200 mg, 400 mg and 600 mg
RDEA594 200 mg qd for 7 days followed by 400 mg qd for 7 days followed by 600 mg qd for 14 days
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Uricosuric agent for the treatment of gout
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Comparador de placebos: Matching placebo
RDEA594 matching placebo qd for 28 days
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Placebo a juego
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Periodo de tiempo |
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To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28 days of dosing by treatment group.
Periodo de tiempo: 28 Days
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28 Days
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Medidas de resultado secundarias
Medida de resultado |
Periodo de tiempo |
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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 weekly study visit during the Double-Blind Period.
Periodo de tiempo: 28 Days
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28 Days
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To evaluate the absolute and percent reduction from baseline in sUA levels at each weekly study visit.
Periodo de tiempo: 28 Days and through extension
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28 Days and through extension
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To evaluate the percentage change in 24-hour urine urate level (excretion) from baseline to Day 28.
Periodo de tiempo: 28 Days and through extension
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28 Days and through extension
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To evaluate the incidence of gout flares.
Periodo de tiempo: 28 Days and through extension
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28 Days and through extension
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To evaluate the safety and tolerability of RDEA594 in subjects with gout.
Periodo de tiempo: 28 Days and through extension
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28 Days and through extension
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To evaluate the proportion of subjects whose sUA level decreases to or is maintained at <6.0 mg/dL in the Open-Label Extension Period.
Periodo de tiempo: 18 Months
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18 Months
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Patrocinador
Investigadores
- Director de estudio: Vijay Hingorani, MD, PhD, MBA, Ardea Biosciences, Inc.
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio
1 de julio de 2009
Finalización primaria (Actual)
1 de marzo de 2010
Finalización del estudio (Actual)
1 de septiembre de 2011
Fechas de registro del estudio
Enviado por primera vez
7 de agosto de 2009
Primero enviado que cumplió con los criterios de control de calidad
7 de agosto de 2009
Publicado por primera vez (Estimar)
10 de agosto de 2009
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
7 de marzo de 2014
Última actualización enviada que cumplió con los criterios de control de calidad
5 de febrero de 2014
Última verificación
1 de febrero de 2014
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- RDEA594-202
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .