Clinical trials: Hyperuricemia, Gout
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, Hyperuricemia
Phase 2 Study of URC102 to Assess the Efficacy and Safety in Gout Patients
The purpose of this study is to assess safety, PK/PD and Urate Lowering Effect of URC102 in gout patients with hyperuricemia
- Trial name
- NCT02290210
- Testing
- URC102 0.25mg, URC102 0.5mg, URC102 1.0mg
- Where
- South Korea
- Volunteers
- 64 people
- Sponsor
- JW Pharmaceutical
Hyperuricemia or Gout
D-0120 Safety and PK/PD Study in China
It is a randomized, double-blind, placebo-controlled, multiple-administration, multiple-dose, dose-escalating, phase Ib/IIa clinical study to evaluate the safety, tolerability, PK and PD of D-0120 in healthy subjects and…
- Trial name
- NCT03923868
- Testing
- D-0120
- Where
- 6 sites in China
- Volunteers
- 52 people, healthy volunteers welcome
- Sponsor
- InventisBio Co., Ltd
Primary Gout and Hyperuricemia
The Efficacy and Safety of SHR4640 Tablet Combined With 40 mg Febuxostat Tablets in the Treatment of Primary Gout and Hyperuricemia
SHR4640 tablets is a highly selective and potent URAT1 inhibitors. The study is being conducted to evaluate the efficacy, and safety of SHR4640 tablet combined with 40 mg/d febuxostat tablet in reducing uric acid in subjects with…
- Trial name
- NCT07362355
- Testing
- SHR4640 ；Febuxostat, SHR4640 ; Febuxostat, SHR4640
- Where
- China
- Volunteers
- 340 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Gout
Dose Finding Study to Evaluate Safety and Efficacy of 3 Dosages of SAP 001.
The aim of this study is to confirm the safety and pharmacological characteristics of SAP-001, evaluate its efficacy in lowering sUA and tophus burden, and identify the appropriate dose regimen for future studies in adult…
- Trial name
- NCT05690204
- Testing
- SAP-001
- Where
- 16 sites in United States, Puerto Rico
- Volunteers
- 87 people
- Sponsor
- Shanton Pharma Pte. Ltd.
Hyperuricemia With or Without Gout
Benzbromarone-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout
FYU-981 or Benzbromarone are administrated to hyperuricemia patients with or without gout for 14 weeks to compare the efficacy and safety of these drugs by the method of multicenter, randomized, double-blind, ascending dose…
- Trial name
- NCT03100318
- Testing
- FYU-981, Benzbromarone
- Where
- Japan
- Volunteers
- 201 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
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
Primary Gout, Hyperuricemia
Phase II/III Study of AR882 Capsules Compared to Febuxostat Tablets in Patients with Primary Gout and Hyperuricemia
The goal of this clinical trial is to evaluate the efficacy and safety of AR882 Capsules in patients with primary gout and hyperuricemia.
- Trial name
- NCT06603142
- Testing
- Febuxostat 20MG Tablets, AR882 25MG, AR882 12.5MG
- Where
- China
- Volunteers
- 636 people
- Sponsor
- Guangzhou Ruianbo Pharmaceutical Technology Co., Ltd
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.
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 With Hyperuricemia in Adults
Clinical Study of HR091506 Tablets in Treatment of Gout With Hyperuricemia in Adults
The study is being conducted to evaluate the efficacy, and safety of HR091506 tablets for treatment of gout with hyperuricemia in adults, and to compare the results with febuxostat tablets in the same doses.
- Trial name
- NCT06139393
- Where
- China
- Volunteers
- 765 people
- Sponsor
- Jiangsu HengRui Medicine Co., 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
Scintigraphy Study in Healthy Volunteers to Characterize the Performance of ALLN-346 Tablets
The purpose of the study is to understand the gastrointestinal transit time and disintegration behavior of the formulations in vivo in normal healthy volunteers when ALLN-346 formulations are given with light meal or in fasted or…
- Trial name
- NCT05168683
- Testing
- Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing with light meal, Each ALLN-346 treatment will be radiolabelled to contain 4 MBq 99mTc at time of dosing in fasted/fed state
- Where
- United Kingdom
- Volunteers
- 12 people, healthy volunteers welcome
- Sponsor
- Allena Pharmaceuticals
Hyperuricemia
ALLN-346 Single Ascending Dose (SAD) Study in Healthy Volunteers
The purpose of this study is to evaluate the safety of ALLN-346 in healthy volunteers, in this first in human, single ascending dose study. ALLN-346 is an enzyme that degrades urate in the gastrointestinal tract.
- Trial name
- SAD (NCT04236219)
- Testing
- ALLN-346
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- Allena Pharmaceuticals
Hyperuricemia
Dose-finding and Safety Study of SHR4640 in Subjects With Hyperuricemia
The objective of the study is to assess efficacy and safety of SHR4640 in subjects with hyperuricemia.
- Trial name
- NCT03185793
- Testing
- SHR4640, benzbromarone
- Where
- China
- Volunteers
- 198 people
- Sponsor
- Jiangsu HengRui Medicine Co., Ltd.
Gout, Hyperuricemia
A Randomized, Double-Blind, Dose-Response Study of the Safety and Uric Acid Effects of Oral Ulodesine Added to Allopurinol in Subjects With Gout and Concomitant Moderate Renal Insufficiency
To evaluate the overall safety and tolerability of ulodesine when combined with allopurinol in subjects with moderate renal insufficiency.
- Conditions
- Gout, Hyperuricemia, Arthritis, Joint Disease
- Trial name
- NCT01407874
- Testing
- Ulodesine (BCX4208) 5 mg, Ulodesine (BCX4208) 10 mg
- Where
- 10 sites in United States
- Volunteers
- 20 people
- Sponsor
- BioCryst Pharmaceuticals
Gout, Hyperuricemia
The Effect of Naproxen on the Pharmacokinetic Profile of LC350189 in Healthy Adults
This is a Phase 1, open-label, fixed-sequence, 3-period, 2-way drug interaction study designed to assess the pharmacokinetics, pharmacodynamics, safety, and tolerability of LC350189 and Naproxen when administered alone and in…
- Trial name
- NCT04139824
- Testing
- Xanthine Oxidase Inhibitor, nonsteroidal anti-inflammatory drug
- Where
- United States
- Volunteers
- 24 people, healthy volunteers welcome
- Sponsor
- LG Chem
Hyperuricemia With or Without Gout
Febuxostat-Controlled, Double-Blind, Comparative Study of FYU-981 in Hyperuricemia With or Without Gout
FYU-981 or Febuxostat are administrated to hyperuricemia patients (underexcretion and mixed types) with or without gout for 14 weeks to compare the efficacy and safety of these drugs by the method of multicenter, randomized…
- Trial name
- NCT03372200
- Testing
- FYU-981, Febuxostat
- Where
- Japan
- Volunteers
- 203 people
- Sponsor
- Mochida Pharmaceutical Company, Ltd.
Gout and Hyperuricemia
Clinical Trial of BR2251 Tablets for Patients With Primary Gout and Hyperuricemia
This study is a randomized, double-blind, non-befloxacin-controlled, multicenter, phase II clinical trial, evaluating the efficacy, safety, and pharmacokinetic characteristics of BR2251 tablets when administered multiple times in…
- Trial name
- BR2251-201 (NCT07498647)
- Testing
- BR2251, Febuxostat
- Volunteers
- 160 people
- Sponsor
- BioRay Pharmaceutical Co., Ltd.