Clinical trials: Hyperuricemia, Gout
Gout
Efficacy and Safety of Oral Febuxostat in Participants With Gout
The purpose of this study is to compare the efficacy and safety of febuxostat, once Daily (QD), to allopurinol in subjects with hyperuricemia and gout.
- Trial name
- CONFIRMS (NCT00430248)
- Testing
- Febuxostat, Allopurinol
- Where
- 258 sites in United States
- Volunteers
- 2,269 people
- Sponsor
- Takeda
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.
Gout Patients
Phase 2a Study of AR882 Alone and in Combination With Febuxostat or Allopurinol in Gout Patients
The study is designed to evaluate the PK/PD, safety and tolerability of AR882 alone or in combination with febuxostat or allopurinol when administered to gout patients.
- Trial name
- NCT04155918
- Testing
- Group 1: AR882 Alone and in Combination with Febuxostat (FBX), Group 2: AR882 Alone and in Combination with Allopurinol (ALLO)
- Where
- New Zealand
- Volunteers
- 30 people
- Sponsor
- Arthrosi Therapeutics
Gout, Hyperuricemia
Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients
The aim of this 6-month randomized multi-regional double-blind parallel group placebo-controlled phase 3 study is to assess the efficacy and safety of three different doses of Tigulixostat in gout patients with hyperuricemia.
- Conditions
- Gout, Hyperuricemia, Gout Flare, Tophi
- Trial name
- EURELIA1 (NCT05586958)
- Testing
- Tigulixostat
- Where
- 52 sites in United States, Georgia and 2 more
- Volunteers
- 354 people
- Sponsor
- LG Chem
Gout, Hyperuricemia
Study of Tranilast Alone or in Combination With Allopurinol in Subjects With Hyperuricemia
This is a randomized, double-blind, 3-period 3-treatment crossover followed by a 2-period 2-treatment crossover, phase 2 study in patients with documented hyperuricemia to evaluate the effect of tranilast on allopurinol…
- Trial name
- NCT01052987
- Testing
- Tranilast, Allopurinol, Combination - Tranilast and Allopurinol
- Where
- 3 sites in United States
- Volunteers
- 24 people
- Sponsor
- Nuon Therapeutics, Inc.
Hyperuricemia With or Without Gout
Study of FYU-981 in Hyperuricemia With or Without Gout
The purpose of this study is confirmatory investigation of safety and efficacy of FYU-981 administered orally to hyperuricemic patients with and without gout for 34 or 58 weeks by the method of multicenter, open label and…
- Trial name
- NCT03006445
- Testing
- FYU-981
- Where
- Japan
- Volunteers
- 330 people
- Sponsor
- Fuji Yakuhin Co., Ltd.
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.
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
Study of FYU-981 in Hyperuricemic Outpatients With or Without Gout (Effect on Two Hyperuricemic Types)
To investigate the pharmacodynamics and safety of FYU-981 administered orally once a day for 14 weeks, to uric acid-overproduction type or uric acid-underexcretion type of male hyperuricemic outpatients with or without gout.
- Trial name
- NCT03375632
- Testing
- FYU-981
- Where
- Japan
- Volunteers
- 26 people
- Sponsor
- Mochida Pharmaceutical Company, Ltd.
Gout
A Study of Dotinurad Versus Allopurinol in Participants With Gout
The primary objective of this study is to evaluate the efficacy of dotinurad in lowering serum uric acid (sUA) at Week 24 compared with allopurinol in adult participants with hyperuricemia associated with gout.
- Trial name
- NCT07089875
- Testing
- Allopurinol, Dotinurad
- Where
- 119 sites in United States, Poland and 1 more
- Volunteers
- 500 people
- Sponsor
- Crystalys Therapeutics
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
Safety and Efficacy Study of Intramuscular Uricase-PEG 20
The purpose of this study is to assess the safety, pharmacokinetics and pharmacodynamics of single and multiple intramuscular doses of Uricase-PEG 20
- Trial name
- NCT01038947
- Testing
- Uricase-PEG 20
- Where
- 2 sites in United States
- Volunteers
- 28 people, healthy volunteers welcome
- Sponsor
- EnzymeRx
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
Gout, Hyperuricemia
Relative Bioavailability Study to Assess an LC350189 Tablet Compared to an LC350189 Capsule in Healthy Adults
This is an open-label, randomized, crossover, single dose study. Two single doses of LC350189(tablet or capsule formulations) will be administered with a washout period of at least 4-day between the doses to investigate the…
- Trial name
- NCT04886050
- Testing
- LC350189 Tablet, LC350189 Capsule
- Where
- United States
- Volunteers
- 23 people, healthy volunteers welcome
- Sponsor
- LG Chem
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
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.
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
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
Validation Study of Physical Measurement of Tophi
The purpose of this study is to determine the inter- and intra-rater reproducibility of direct physical measurement of tophus nodules in subjects with gout.
- Trial name
- NCT00175006
- Testing
- Measurement of Tophi to validate procedure
- Volunteers
- 13 people
- Sponsor
- Takeda
Hyperuricemia, Gout
Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease
The purpose of this Phase IIa study is to evaluate the safety, tolerability and pharmacodynamics of ALLN-346 in subjects with hyperuricemia and gout, and with mild to moderate chronic kidney disease.
- Conditions
- Hyperuricemia, Gout, Chronic Kidney Diseases
- Trial name
- NCT04987294
- Testing
- ALLN-346
- Where
- 17 sites in United States
- Volunteers
- 19 people
- Sponsor
- Allena Pharmaceuticals