Gout Dose Response Study
5. februar 2014 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Faktiske)
123
Fase
- Fase 2
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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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, Canada, V3K 3P4
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Kelowna, British Columbia, Canada, V1Y8E7
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Ontario
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Thornhill, Ontario, Canada, L4J6W6
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Toronto, Ontario, Canada, M9W 4L6
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Quebec
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Mirabel, Quebec, Canada, J7J 2K8
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California
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Los Angeles, California, Forente stater, 90017
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Florida
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DeLand, Florida, Forente stater, 32720
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North Carolina
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Winston-Salem, North Carolina, Forente stater, 27103
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Tennessee
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Jackson, Tennessee, Forente stater, 38305
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Tbilisi, Georgia, 0186
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Tbilisi, Georgia, 0102
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Elblag, Polen, 82-300
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Lodz, Polen, 90-153
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Lublin, Polen, 20-607
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Poznan, Polen, 61-289
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Radom, Polen, 26-610
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Wroclaw, Polen, 53-025
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Bruntal, Tsjekkisk Republikk, 792 01
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Prague, Tsjekkisk Republikk, 140 00
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Prague, Tsjekkisk Republikk, 148 00
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Goch, Tyskland, 47574
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Hamburg, Tyskland, 22143
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Nuremberg, Tyskland, 90402
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
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.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: RDEA594 200 mg qd for 28 days
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Uricosuric agent for the treatment of gout
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Eksperimentell: 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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Eksperimentell: 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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Placebo komparator: Matching placebo
RDEA594 matching placebo qd for 28 days
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Matchende placebo
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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.
Tidsramme: 28 Days
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28 Days
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Sekundære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 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.
Tidsramme: 18 Months
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18 Months
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studieleder: Vijay Hingorani, MD, PhD, MBA, Ardea Biosciences, Inc.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. juli 2009
Primær fullføring (Faktiske)
1. mars 2010
Studiet fullført (Faktiske)
1. september 2011
Datoer for studieregistrering
Først innsendt
7. august 2009
Først innsendt som oppfylte QC-kriteriene
7. august 2009
Først lagt ut (Anslag)
10. august 2009
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
7. mars 2014
Siste oppdatering sendt inn som oppfylte QC-kriteriene
5. februar 2014
Sist bekreftet
1. februar 2014
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- RDEA594-202
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .