Clinical trials: Gout and Hyperuricemia
Gout; Hyperuricemia
Single Dose Study of SHR4640 in Healthy Subjects
The objective of the study is to assess the safety, tolerance, food effect, pharmacokinetic and pharmacodynamic properties of single dose adminstration of SHR4640 in healthy volunteers.
- Trial name
- NCT02815839
- Testing
- SHR4640
- Where
- China
- Volunteers
- 50 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
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, Hyperuricemia
Study of Tranilast Alone or in Combination With Febuxostat in Patients With Hyperuricemia
This is a randomized, double-blind, 3-period crossover phase 2 study in patients with documented hyperuricemia to evaluate the effect of tranilast on febuxostat pharmacokinetics (PK) and pharmacodynamics (PD) and to evaluate the…
- Trial name
- NCT00995618
- Testing
- Tranilast, Febuxostat, Combination - Tranilast and Febuxostat
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Nuon Therapeutics, Inc.
Gout, Hyperuricemia
Multiple Doses Study of SHR4640 in Male Subjects With High Serum Uric Acid Level
This is a single-Center, randomized, double-Blind, placebo-controlled, multiple ascending-dose Phase I trail.
- Trial name
- NCT03211403
- Testing
- SHR4640
- Where
- Australia
- Volunteers
- 24 people
- Sponsor
- Atridia Pty Ltd.
Gout and Hyperuricemia
PK Effects of SHR4640 on Repaglinide and Midazolam, and the Impact of SHR4640 on QT Interval
The purpose of this study is to evaluate the PK effects of SHR4640 tablets on repaglinide and midazolam, as well as the effects of SHR4640 tablets on the QT interval in healthy subjects.
- Trial name
- NCT06196580
- Testing
- repaglinide; midazolam; SHR4640
- Where
- China
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Gout, Hyperuricemia
Evaluate the PK, PD, and Safety of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Patients With Gout
The purpose of this study is to evaluate pharmacokinetics, pharmacodynamics, safety and potential for drug-drug interaction of arhalofenate when combined with febuxostat in adult population with gout.
- Trial name
- NCT02252835
- Testing
- Arhalofenate, Febuxostat, Colchicine
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- Gilead Sciences
Gout, Hyperuricemia
Renal PK Study of LC350189
This is a Phase 1, open-label, parallel-group, multiple-dose study designed to assess the effect of renal impairment on the PK and PD of LC350189.
- Trial name
- NCT04066712
- Testing
- LC350189 200 mg
- Where
- United States
- Volunteers
- 37 people, healthy volunteers welcome
- Sponsor
- LG Chem
Hyperuricemia With or Without Gout
Safety and Food Effect on Single-Dose Bioavailability of F-02-2-Na in Healthy Adult Subjects
The study is to evaluate the impact of food on the pharmacokinetics of F-02-2-Na in healthy adult subjects by observing the changes in the drug's pharmacokinetic profile-particularly in its absorption process-before and after…
- Trial name
- NCT07346027
- Testing
- Fasting administration of F-02-2-Na (50mg) - Fed administration of F-02-2-Na (50mg), Fed administration of F-02-2-Na (50mg) - Fasting administration of F-02-2-Na (50mg)
- Where
- China
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd.
Acute Gout Flare, Gout Attack
Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
The purpose of this trial is to investigate the efficacy and safety of dapansutrile (OLT1177®) tablets in subjects with an acute gout flare.
- Conditions
- Acute Gout Flare, Gout Attack, Gout Flare, Gouty Arthritis
- Trial name
- NCT05658575
- Testing
- Dapansutrile
- Where
- 40 sites in United States, France and 3 more
- Volunteers
- 300 people
- Sponsor
- Olatec Therapeutics, Inc.
Gout and Asymptomatic Hyperuricemia
A PD/Safety Study of RDEA3170 in Combination With Febuxostat for Treating Gout or Asymptomatic Hyperuricemia Patients
The purpose of this study is to explore the pharmacodynamics (PD), pharmacokinetics (PK), safety, and tolerability of multiple doses of RDEA3170 administered in combination with febuxostat compared to RDEA3170 administered alone…
- Trial name
- NCT02317861
- Testing
- RDEA3170, Febuxostat, Benzbromarone
- Where
- Japan
- Volunteers
- 110 people
- Sponsor
- AstraZeneca
Gout
A Study of Persons With Gout Who Do Not Respond to or Are Allergic to Conventional Therapy
This is a randomized, open-label, multicenter, parallel-groups study of multiple intravenous doses of Puricase, administered intravenously, in 40 patients with symptomatic gout.
- Trial name
- NCT00080210
- Testing
- Puricase
- Where
- 9 sites in United States
- Volunteers
- 40 people
- Sponsor
- Savient Pharmaceuticals
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
Diabetic Nephropathy
Effect of Topiroxostat on Urinary Albumin Excretion Early Stage Diabetic Nephropathy and Hyperuricemia With or Without Gout
The purpose of this study is to investigate the effect of topiroxostat on urinary albumin excretion and the safety in patients with early stage diabetic nephropathy and hyperuricemia with or without gout.
- Trial name
- UPWARD (NCT02327754)
- Testing
- Topiroxostat BID, (Oral daily dosing for 28 weeks)
- Where
- Japan
- Volunteers
- 60 people
- Sponsor
- Sanwa Kagaku Kenkyusho Co., Ltd.
Renal Impairment
Effect of Febuxostat on Renal Function in Patients With Gout and Moderate to Severe Renal Impairment
The purpose of this study is to determine the effect of febuxostat, once daily (QD) or twice daily (BID), on renal function in gout patients with elevated serum urate levels and who have moderate to severe renal impairment.
- Trial name
- NCT01082640
- Testing
- Febuxostat
- Where
- 58 sites in United States
- Volunteers
- 96 people
- Sponsor
- Takeda
Gout, Arthritis, Gouty
Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-301)
This study will assess the serum uric acid lowering effect and safety of AR882 in gout patients at two doses compared to placebo over 12 months
- Conditions
- Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic
- Trial name
- NCT06846515
- Testing
- AR882 50 mg, AR882 75 mg
- Where
- 83 sites in United States
- Volunteers
- 866 people
- Sponsor
- Arthrosi Therapeutics
Gout, Hyperuricemia
Placebo Controlled, Dose Escalation Study to Evaluate Safety, Pharmacokinetics & Efficacy of SAP-001 in Gout Patients
This is a Phase I, Multicenter, Randomized, Double-blind, Placebo controlled, Dose-escalation study to evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SAP-001 in Gout Patients with…
- Trial name
- NCT03857165
- Testing
- SAP-001
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Shanton Pharma Co., Ltd.
Gout and Hyperuricemia
Phase II Dose Finding Study of RDEA3170 Versus Placebo in Japanese Patients With Gout or Asymptomatic Hyperuricemia
This study is to examine the hypothesis that administration of RDEA3170 to Japanese patients with gout or asymptomatic hyperuricemia in doses of 5 mg, 7.5 mg, 10 mg, 12.5 mg and 15 mg once daily, respectively will result in…
- Trial name
- NCT02078219
- Testing
- RDEA3170, Allopurinol
- Where
- 14 sites in Japan
- Volunteers
- 204 people
- Sponsor
- AstraZeneca
Hyperuricemia
Gout Dose Response Study
To compare the proportion of subjects whose serum urate (sUA) level is < 6.0 mg/dL after 28 days of dosing by treatment group.
- Trial name
- NCT00955981
- Testing
- RDEA594
- Where
- 29 sites in United States, Bulgaria and 5 more
- Volunteers
- 123 people
- Sponsor
- Ardea Biosciences, Inc.
Hyperuricemia With or Without Gout
A Study to Evaluate the Safety, Tolerability and Pharmacokinetics of Oral F-02-2-Na Tablets in Adult Subjects
The primary objective of this study is to evaluate the safety, tolerability and pharmacokinetic (PK) profiles of ascending single orally administered doses of F-02-2-Na in adult subjects (to include the Mass Balance) \& multiple…
- Trial name
- NCT07324434
- Testing
- F-02-2-Na Tablet (0.5 mg), F-02-2-Na Tablet (5 mg), F-02-2-Na Tablet (10 mg)
- Where
- China
- Volunteers
- 69 people, healthy volunteers welcome
- Sponsor
- Guangdong Hengqin Novagains Biopharmaceutical Co., Ltd.
Gout, Hyperuricemia
Study of URC102 to Assess the Safety and Efficacy in Gout Patients
The purpose of this study is to assess safety, Pharmacokinetics/Pharmacodynamics and Urate Lowering Effect of URC102 in gout patients.
- Trial name
- NCT02557126
- Testing
- URC102
- Where
- South Korea
- Volunteers
- 76 people
- Sponsor
- JW Pharmaceutical