Clinical trials: Gout Disease
Gout
Allopurinol Combination Study
To compare the proportion of subjects whose serum urate (sUA) levels are < 6.0 mg/dL following 4 weeks of continuous treatment of RDEA594 in combination with allopurinol to allopurinol alone in subjects with documented inadequate…
- Trial name
- RDEA594-203 (NCT01001338)
- Testing
- RDEA594, Allopurinol
- Where
- 44 sites in United States, Canada and 4 more
- Volunteers
- 227 people
- Sponsor
- Ardea Biosciences, 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
Uncontrolled Gout
Pegloticase and Methotrexate Co-administered in Participants With Uncontrolled Gout Who Previously Failed Pegloticase Monotherapy
This is a Phase 4, multicenter, open-label trial of pegloticase with methotrexate (MTX) in adult participants with uncontrolled gout who were previously treated with pegloticase without a concomitant immunomodulator and stopped…
- Trial name
- NCT04772313
- Testing
- Pegloticase, Methotrexate (MTX)
- Where
- 15 sites in United States
- Volunteers
- 11 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
Mild, Moderate and Severe Renal Impairment Study
This is a Phase 1, single-dose, open-label, pharmacokinetic (PK) and pharmacodynamic (PD) study of RDEA3170 in adult male subjects with mild, moderate, and severe renal impairment.
- Trial name
- NCT02219516
- Testing
- RDEA3170
- Where
- 4 sites in United States
- Volunteers
- 31 people
- Sponsor
- Ardea Biosciences, Inc.
Gout
A Study to Evaluate Efficacy of Dotinurad and Febuxostat for the Treatment of Participants With Gout
The primary purpose of the study is to confirm the efficacy of dotinurad 4 milligram (mg) to febuxostat 40 mg on the percentage of participants achieving a serum uric acid (SUA) level less than or equal to (<=) 6.0 milligrams per…
- Trial name
- NCT05007392
- Testing
- Dotinurad, Febuxostat
- Where
- 30 sites in China
- Volunteers
- 451 people
- Sponsor
- Eisai Co., Ltd.
Gout
Dose-Response, Safety and Efficacy of Febuxostat in Subjects With Gout
The purpose of this study is to determine the efficacy of febuxostat, once daily (QD), in reducing serum urate levels in subjects with gout.
- Trial name
- NCT00174967
- Testing
- Febuxostat
- Volunteers
- 153 people
- Sponsor
- Takeda
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, Gout Initiating Urate-loweringUrate-lowering Therapy
A Study of the Efficacy of Genakumab in Prevention of Acute Flares in Gout Patients Initiating Urate-lowering TherapyUrate-lowering (GenSci048-202)
To evaluate the safety and efficacy of Genakumab in prevention of acute flares in gout patients initiating urate-lowering therapyurate-lowering
- Trial name
- Gensci 048-202 (NCT05936281)
- Testing
- Genakumab for injection, Colchicine
- Where
- China
- Volunteers
- 165 people
- Sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
Acute Gouty Arthritis Flares
β-RELIEVED - REsponse in Acute fLare and In prEVEntion of episoDes of Re-flare in Gout - Extension 3 (E3)
This was an 18-month, multi-center, open-label, clinical extension study. Patients completing earlier second extension studies (CACZ885H2356E2 and CACZ885H2357E2) continued to be treated in this combined extension 3 study for any…
- Trial name
- β-RELIEVED (NCT01470989)
- Testing
- ACZ885, Triamcinolone acetonide 40 mg
- Where
- 56 sites in United States, Australia and 7 more
- Volunteers
- 136 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
Gout
A Study of the Efficacy of Canakinumab in Prevention of Acute Flares in Chronic Gout Patients Initiating Allopurinol Therapy (Core Study) and a Long-term Study of the Efficacy and Safety of Canakinumab in Patients With Gout (Extension Study)
The 24-week, dose-ranging, multi-center, double-blind, double-dummy, active-controlled core study investigated the prophylactic effect of canakinumab on the signs and symptoms of acute flares in chronic gout patients initiating…
- Trial name
- NCT00819585
- Testing
- Canakinumab, Colchicine, Allopurinol
- Where
- 89 sites in United States, Argentina and 16 more
- Volunteers
- 432 people
- Sponsor
- Novartis Pharmaceuticals
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
Food Effect Study of Febuxostat XR in Healthy Participants
The purpose of this study is to assess the effect of food on the bioavailability of febuxostat after a single oral dose of 80 mg febuxostat XR and to evaluate the pharmacokinetics (PK) of febuxostat after single oral doses of 40…
- Trial name
- NCT02374164
- Testing
- Febuxostat XR
- Where
- United States
- Volunteers
- 36 people, healthy volunteers welcome
- Sponsor
- Takeda
Gouty Arthritis
Safety & Efficacy of Canakinumab (ACZ885) in Patients With Frequent Flares for Whom Nonsterodial Anti-Inflammatory Drug (NSAIDs) and/ or Colchicine Are Contraindicated, Not Tolerated or Ineffective
The purpose of this pivotal Phase III study is to support the registration of canakinumab for the indication of gout in China, a replicate of global studies CACZ885H2356 \& CACZ885H2357 by demonstrating in patients with frequent…
- Trial name
- NCT01362608
- Testing
- Canakinumab, ACZ885, Triamcinolone acetonide
- Where
- 20 sites in Argentina, China and 2 more
- Volunteers
- 136 people
- Sponsor
- Novartis Pharmaceuticals
Gout, Cardiovascular Diseases
Drug Use Study of Febuxostat After Recent Changes in the Prescribing Information
The prescribing information provides information on medicines. This study will check the number of patients starting febuxostat and the number of febuxostat users with cardiovascular disease after changes to the prescribing…
- Trial name
- NCT04853160
- Where
- United States
- Volunteers
- 24,046 people
- Sponsor
- Takeda