Clinical trials: Hyperuricemia, Gout
Primary Gout and Hyperuricemia
Clinical Study of SHR4640 Tablets Combined With Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia
SHR4640 tablets is a highly selective and potent URAT1 inhibitors,study number is SHR4640-203. The primary purpose of the study is to evaluate the efficacy and safety of the combination of SHR4640 and febuxostat compared with…
- Trial name
- NCT05513976
- Testing
- SHR4640 tablet, febuxostat tablet
- Volunteers
- 129 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Gout, Arthritis, Gouty
Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-302)
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
- NCT06439602
- Testing
- AR882 50 mg, AR882 75 mg
- Where
- 68 sites in United States, Australia and 3 more
- Volunteers
- 818 people
- Sponsor
- Arthrosi Therapeutics
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, Arthritis, Gouty
Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination With Allopurinol in Patients With Tophaceous Gout
This study will assess the serum urate lowering effect, tophi reduction, and safety of AR882 alone and in combination with allopurinol in patients with tophaceous gout at two doses compared to allopurinol over 24 weeks.
- Conditions
- Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic
- Trial name
- NCT05253833
- Testing
- AR882 Dose 1, AR882 Dose 2, Allopurinol Tablet
- Where
- 12 sites in United States, New Zealand and 1 more
- Volunteers
- 42 people
- Sponsor
- Arthrosi Therapeutics
Hyperuricemia
Study of FYU-981 in Hyperuricemia With or Without Gout
The purpose of this study is confirmatory investigation of safety and efficacy (dose response and optimal dose according to the percent reduction from baseline in serum urate level at the final visit) of FYU-981 administered…
- Trial name
- NCT02416167
- Testing
- FYU-981
- Where
- Japan
- Volunteers
- 200 people
- Sponsor
- Fuji Yakuhin Co., Ltd.
Gout, Hyperuricemia
A Dose Finding Study to Assess Efficacy and Safety of IBI128 in Chinese Gout Subjects
IBI128 (Tigulixostat) is a novel non-purine selective inhibitor of xanthine oxidase (XO). The XO inhibitors lower uric acid concentrations in serum by inhibiting the production of uric acid.
- Trial name
- NCT06501534
- Testing
- Febuxostat, IBI128
- Where
- China
- Volunteers
- 84 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Gout, Hyperuricemia
PK and Safety Evaluation Study of SAP-001 in Adult Subjects With Normal and Impaired Renal Function
This is a multicenter, open-label, non-randomized, parallel-group, single-dose, 2-part, adaptive study in which up to approximately 32 adult subjects will be enrolled in one of 4 groups (8 subjects per group) with varying degrees…
- Trial name
- NCT06729853
- Testing
- SAP-001
- Where
- 2 sites in United States
- Volunteers
- 32 people, healthy volunteers welcome
- Sponsor
- Shanton Pharma Pte. Ltd.
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.
Hyperuricemia, Gout
An Inpatient Study of ALLN-346 (Engineered Urate Oxidase) in Hyperuricemic Subjects (Study 201)
The purpose of this Phase IIa study is to evaluate the safety and tolerability of ALLN-346 in subjects with hyperuricemia in an inpatient, controlled setting.
- Conditions
- Hyperuricemia, Gout, Chronic Kidney Diseases
- Trial name
- NCT04987242
- Testing
- ALLN-346
- Where
- United States
- Volunteers
- 16 people
- Sponsor
- Allena Pharmaceuticals
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, Hyperuricemia
SAD,MAD and Food Effect Study of SAP-001 Tablets in Chinese Subjects
To evaluate the pharmacokinetics (PK) profile of single or multiple oral doses of SAP-001 tablets in healthy Chinese subjects and gout patients with hyperuricemia.
- Trial name
- NCT06678581
- Testing
- SAP-001
- Where
- China
- Volunteers
- 70 people, healthy volunteers welcome
- Sponsor
- Shanton Pharma Co., Ltd.
Gout, Hyperuricemia
Study to Evaluate sUA Lowering Activity, Safety and Efficacy of Oral Ulodesine Added to Allopurinol
The purpose of this study is to determine whether ulodesine and allopurinol combined for 12 weeks are effective in treating gout in patients who are not adequately responding to allopurinol alone.
- Conditions
- Gout, Hyperuricemia, Arthritis, Joint Disease
- Trial name
- NCT01265264
- Testing
- ulodesine
- Where
- 54 sites in United States
- Volunteers
- 279 people
- Sponsor
- BioCryst Pharmaceuticals
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
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
Hyperuricemia, Gout
Study 102: Multiple Ascending Dose Study of ALLN-346 (Engineered Urate Oxidase)
The purpose of this Phase I study is to evaluate the safety and tolerability of ALLN-346 in in normal healthy volunteers, in an ascending dose design.
- Trial name
- MAD (NCT04829435)
- Testing
- ALLN-346
- Where
- United States
- Volunteers
- 18 people, healthy volunteers welcome
- Sponsor
- Allena Pharmaceuticals
Gout
Clinical Study to Evaluate the Pharmacokinetic Characteristics Between TMX-67 and Feburic® in Healthy Volunteers
This study was designed to compare and evaluate the pharmacokinetic characteristics of febuxostat after single oral administration of TMX-67 (test drug) and Feburic® tablet in healthy adults; and to evaluate safety and tolerance…
- Trial name
- NCT01563432
- Testing
- Feburic®, TMX-67
- Where
- South Korea
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- SK Chemicals Co., Ltd.
Gout, Hyperuricemia
Placebo Controlled, Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAP-001 in Gout Patients
This is a Phase II, Multicenter, Randomized, Double-blind, Placebo controlled, Multiple Dose study to evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAP-001 in Gout Patients with Hyperuricemia.
- Trial name
- NCT04040816
- Testing
- SAP-001
- Where
- 6 sites in United States
- Volunteers
- 40 people
- Sponsor
- Shanton Pharma Co., Ltd.
Hyperuricemia, Gout
Study of Levotofisopam 50 mg Three Times a Day (TID) Administered for 7 Days on Hyperuricemia and Gout
The purpose of this study is to determine whether levotofisopam is safe and effective in the treatment of hyperuricemia and gout.
- Trial name
- NCT01519687
- Testing
- levotofisopam
- Where
- United States
- Volunteers
- 20 people
- Sponsor
- Pharmos
Hyperuricemia, Gout
Open Label Safety/Efficacy Study of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Gout Patients
The purpose of this study is to determine whether arhalofenate is safe and effective when dosed in combination with febuxostat in lowering serum uric acid in patients with gout.
- Trial name
- NCT01416402
- Testing
- Arhalofenate, Febuxostat, Colchicine
- Where
- United States
- Volunteers
- 27 people
- Sponsor
- Gilead Sciences
Gout
Study to Evaluate the Urate-Lowering Activity and Safety of Oral BCX4208 Administered in Subjects With Gout
The study will be conducted in two parts. The first is a parallel-group design, evaluating doses of 40 mg, 80 mg or 120 mg BCX-4208.
- Trial name
- NCT00985127
- Testing
- BCX4208
- Where
- 24 sites in United States
- Volunteers
- 99 people
- Sponsor
- BioCryst Pharmaceuticals