Clinical trials: Gout
Gout
Allopurinol Outcome Study
This is a study of allopurinol in gout patients with hyperuricemia that will evaluate the safety and serum urate (sUA) lowering capability of allopurinol as a urate lowering therapy (ULT) for up to six months.
- Trial name
- LASSO (NCT01391325)
- Testing
- Allopurinol
- Where
- 173 sites in United States, Australia and 5 more
- Volunteers
- 1,735 people
- Sponsor
- Ardea Biosciences, Inc.
Gout, Gouty Arthritis
Evaluation of Efficacy and Safety of AR882 and XOI Co-administration in Uricase Treatment Failed Patients
This study will assess the effect of AR882 and XOI co-administration on sUA lowering as well as reducing tophus burden in the population that has failed uricase treatment (eg., pegloticase).
- Conditions
- Gout, Gouty Arthritis, Hyperuricemia, Gout Chronic
- Trial name
- NCT07116746
- Testing
- AR882 75 mg, XOI Low Dose, XOI High Dose
- Where
- 8 sites in United States
- Volunteers
- 15 people
- Sponsor
- Arthrosi Therapeutics
Gout
D-0120 Safety and PK/PD, Food Effect Study in Healthy Volunteers
This initial clinical study in the US will be a randomized, double-blind, placebo-controlled, single-dose, dose-escalation, and sequential cohort study to evaluate the safety, tolerability, PK and PD of D-0120-NA in fasting…
- Trial name
- NCT03291782
- Testing
- D-0120
- Where
- United States
- Volunteers
- 39 people, healthy volunteers welcome
- Sponsor
- InventisBio Co., Ltd
Gout
The Drug-Drug Interaction of SHR4640, Febuxostat and Colchicine in Patients With Gout
The objective of the study is to assess the pharmacodynamic properties of drug-drug of SHR4640, Febuxostat and Colchicine interaction in patients with gout.
- Trial name
- NCT03131583
- Testing
- Colchicine, Febuxostat, SHR4640
- Where
- China
- Volunteers
- 15 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Gout
Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout
The overall objective of the study is to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of the concomitant use of pegloticase with methotrexate (MTX) to enhance the response rate seen with pegloticase alone…
- Trial name
- MIRROR OL (NCT03635957)
- Testing
- Pegloticase, Methotrexate (MTX), Standard Gout Flare Prophylaxis
- Where
- 6 sites in United States
- Volunteers
- 14 people
- Sponsor
- Amgen
Gout, Chronic Kidney Disease (CKD)
A Phase 4 Safety and Efficacy Study to Evaluate Lesinurad 200 mg in Participants With Gout and Renal Impairment
This study evaluates the safety and efficacy of lesinurad administered with an XOI versus a placebo plus an XOI in gout participants who have moderate renal impairment and who are not at target level of serum urate (sUA).
- Trial name
- NCT03226899
- Testing
- Lesinurad, XOI, colchicine
- Where
- 116 sites in United States, Czechia and 2 more
- Volunteers
- 242 people
- Sponsor
- Ironwood Pharmaceuticals, Inc.
Gout, Hyperuricemia
Mass Balance Study of [14C]LC350189 in Healthy Volunteers
This is a Phase 1, open-label, single-dose, mass balance study designed to evaluate the absorption, metabolism, and excretion of [14C] radiolabeled LC350189 after oral administration.
- Trial name
- NCT04070846
- Testing
- [14C] LC350189
- Where
- United States
- Volunteers
- 6 people, healthy volunteers welcome
- Sponsor
- LG Chem
Gout, Hyperuricemia
A Study to Assess Efficay and Safety of LC350189 Different Doses in Gout Patients With Hyperuricemia
The aim of this 12-week randomized multicenter double-blind parallel group placebo-controlled dose finding study is to assess the efficacy and safety of three different doses of LC350189 in subjects with hyperuricemia and a…
- Trial name
- NCT03934099
- Testing
- LC350189 formulated capsule
- Where
- 34 sites in United States
- Volunteers
- 156 people
- Sponsor
- LG Chem
Acute Gout
A Phase Ib/II Study of Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection in Chinese Participants With Acute Gout
The purpose of this study is to determine the target dose of phase II and to evaluate the safety, tolerability, pharmacokinetics and efficacy of recombinant anti-IL-1β humanized monoclonal antibody injection at different doses in…
- Trial name
- NCT05588908
- Testing
- Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 100 mg (phase Ib), Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 200 mg (phase Ib), Recombinant Anti-IL-1β Humanized Monoclonal Antibody Injection 300 mg (phase Ib)
- Where
- 3 sites in China
- Volunteers
- 120 people
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd.
Gout, Hyperuricemia
Safety and Efficacy Study of Intravenous Uricase-PEG 20
The purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of single intravenous doses of Uricase-PEG 20.
- Trial name
- NCT01021241
- Testing
- Uricase-PEG 20
- Where
- 2 sites in United States
- Volunteers
- 20 people, healthy volunteers welcome
- Sponsor
- EnzymeRx
Gout
Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors
This study will assess the serum uric acid lowering effects and safety of lesinurad compared to placebo in patients who are intolerant or have a contraindication to allopurinol or febuxostat.
- Trial name
- LIGHT (NCT01508702)
- Testing
- lesinurad
- Where
- 106 sites in United States, Australia and 5 more
- Volunteers
- 214 people
- Sponsor
- Ardea Biosciences, Inc.
Gout
A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory Gout
The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase…
- Trial name
- NCT06229145
- Testing
- Pegloticase, Methotrexate
- Where
- 74 sites in United States
- Volunteers
- 306 people
- Sponsor
- Amgen
Gout
A Study to Investigate the Clinical Effect and the Safety of PRX-115 Infused Intravenously at Different Dosing Regimens, With and Without Methotrexate, Versus Placebo in Adults Gout Patients (RELEASE)
This is a multicenter, randomized, double-blind, placebo-controlled phase II study assessing the efficacy, safety, and dosing regimen selection of multiple IV infusions of PRX-115 over 24 weeks, with or without MTX, versus the…
- Trial name
- RELEASE (NCT07280156)
- Testing
- PRX-115, Methotrexate (MTX)
- Where
- 35 sites in United States, Georgia and 1 more
- Volunteers
- 150 people
- Sponsor
- Protalix
Gout
A Clinical Trial of HEC93077 in Chinese Healthy Subjects and HUA Patients With Single or Multiple Dosing
A phase 1 clinical trial of HEC93077,to evaluate the safety ,PK,PD and food effect in Chinese healthy subjects and HUA patients after single or multiple dosing.
- Trial name
- NCT05127772
- Testing
- HEC93077
- Where
- China
- Volunteers
- 126 people, healthy volunteers welcome
- Sponsor
- Sunshine Lake Pharma Co., Ltd.
Acute Gouty Arthritis
Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.
- Trial name
- NCT01431638
- Testing
- Canakinumab 150mg in prefilled syringe
- Where
- 68 sites in United States, Canada and 2 more
- Volunteers
- 397 people
- Sponsor
- Novartis Pharmaceuticals
Uncontrolled Gout, Chronic Gout
A Phase 4, Open-label Study of KRYSTEXXA® (Pegloticase) Co-administered With Methotrexate (MTX) in Patients With Uncontrolled Gout (FORWARD OL)
This trial is to assess efficacy, safety, blood levels and bodily effects of up to 2 dose levels of intravenous (IV) pegloticase (KRYSTEXXA) infusions at every 4 week intervals (Q4 Weeks) for up to 6 months (Day 1 to 24 weeks…
- Trial name
- FORWARD OL (NCT04762498)
- Testing
- Pegloticase, Methotrexate (MTX)
- Where
- 12 sites in United States
- Volunteers
- 54 people
- Sponsor
- Amgen
Bleeding ,Arrhythmias, Heart Failure, Acute Renal Failure, Acute Liver Failure, Dyspnoea, Gout
Extended Drug Utilization Study Among Patients Exposed to Ticagrelor, Clopidogrel and Prasugrel
The purpose of the study is to describe patient characteristics and drug usage among patients that are prescribed ticagrelor for the first time and to compare them with patients who are prescribed clopidogrel and prasugrel for…
- Trial name
- NCT01276275
- Testing
- Risk of selected safety events
- Where
- Sweden
- Volunteers
- 7,200 people
- Sponsor
- AstraZeneca
Gout
Phase III Trial of Febuxostat in Korea Gout Patients
This study was designed to evalute the efficacy and safety of Febuxostat after oral administration to patientd with gout in Korea
- Trial name
- NCT00821392
- Testing
- Febuxostat
- Volunteers
- 181 people
- Sponsor
- SK Chemicals Co., Ltd.
Primary Gout With Hyperuricemia in Adults
A Trial of HR091506 Tablets in Treatment of Primary Gout With Hyperuricemia in Adults
The study is being conducted to evaluate the efficacy and safety of HR091506 tablets for treatment of primary gout with hyperuricemia in adults, and to compare the results with febuxostat tablets in the same doses.
- Trial name
- NCT05347498
- Volunteers
- 90 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Joint Damage
Effect of Febuxostat on Joint Damage in Hyperuricemic Subjects With Early Gout
This purpose of this study is to assess the effect of febuxostat, once daily (QD), on joint damage in patients with elevated serum urate levels and gout.
- Trial name
- NCT01078389
- Testing
- Febuxostat
- Where
- 56 sites in United States
- Volunteers
- 314 people
- Sponsor
- Takeda