Clinical trials: Gout Disease
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.
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
Review of Safety Using Rilonacept in Preventing Gout Exacerbations (RE-SURGE)
The purpose of this clinical research study is to determine the safety and effectiveness of an experimental drug called rilonacept in subjects with gout who are on urate-lowering therapy.
- Trial name
- NCT00856206
- Testing
- Rilonacept
- Where
- 124 sites in United States, Germany and 4 more
- Volunteers
- 1,315 people
- Sponsor
- Regeneron Pharmaceuticals
Arthritis, Gouty
Efficacy and Safety of a Single Dose of Canakinumab (ACZ885) in Hospitalized Patients With Acute Gout
This is an exploratory proof-of-concept study to evaluate the safety and efficacy of canakinumab (ACZ885) for inflammation and pain associated with acute gouty arthritis.
- Trial name
- NCT00663169
- Testing
- canakinumab, dexamethasone
- Where
- 4 sites in United States, Switzerland and 1 more
- Volunteers
- 6 people
- Sponsor
- Novartis
Gout
A Phase Ib Clinical Trial of Peguricase for Injection With Methotrexate in Patients With Uncontrolled Gout.
To evaluate the safety and tolerability of peguricase for injection with methotrexate in patients with gout who remain uncontrolled after standardized treatment with conventional uric acid-lowering drugs, to determine the…
- Trial name
- NCT06298071
- Testing
- SIBP-R002, Methotrexate
- Where
- China
- Volunteers
- 36 people
- Sponsor
- Shanghai Institute Of Biological Products
Gout, Moderate Renal Impairment
Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout and Moderate Renal Impairment
The purpose of this study is to evaluate the efficacy and safety of febuxostat 40 mg extended release (XR) and 80 mg XR in comparison with febuxostat 40 mg immediate release (IR) and 80 mg IR, respectively, in gout participants…
- Trial name
- NCT02128490
- Testing
- Febuxostat IR, Febuxostat XR, Colchicine
- Where
- 89 sites in United States
- Volunteers
- 189 people
- Sponsor
- Takeda
Gout
Phase 2a RDEA3170 and Allopurinol Combination Study in Gout Subjects
This is a Phase 2a, randomized, open-label, multicenter study to assess the pharmacodynamic (PD) effects of RDEA3170 administered in combination with allopurinol compared with allopurinol administered alone in adult subjects with…
- Trial name
- NCT02498652
- Testing
- RDEA3170 2.5 mg, allopurinol 300 mg
- Where
- 4 sites in United States
- Volunteers
- 41 people
- Sponsor
- Ardea Biosciences, Inc.
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
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, 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
The the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of XNW3009 in Health Subject
XNW3009 is a small molecule hURAT1 inhibitor developed independently by Sinovent Pty Ltd., and is intended to treat gout-related hyperuricemia.
- Trial name
- NCT04040907
- Testing
- XNW3009
- Where
- Australia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Evopoint Biosciences Inc.
Gout
Long-Term Safety of Febuxostat in Subjects With Gout.
The purpose of this study is to evaluate the long-term safety of febuxostat, once daily (QD), in maintaining serum urate levels within clinically acceptable levels in subjects with gout.
- Trial name
- FOCUS (NCT00174941)
- Testing
- Febuxostat
- Volunteers
- 116 people
- Sponsor
- Takeda
Gout
A Study to Evaluate ALN-XDH in Healthy Subjects and Patients With Gout
The purpose of this study is to: Part A: Evaluate the safety and tolerability of single ascending doses of ALN-XDH in healthy adult participants Part B: Evaluate the safety, tolerability and efficacy of ALN-XDH as monotherapy in…
- Trial name
- NCT05256810
- Testing
- ALN-XDH
- Where
- United Kingdom
- Volunteers
- 44 people, healthy volunteers welcome
- Sponsor
- Alnylam Pharmaceuticals
Gout, Arthritis, Gouty
Phase 2b Evaluation of Efficacy and Safety of AR882 in Gout Patients
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 weeks.
- Conditions
- Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic
- Trial name
- NCT05119686
- Testing
- AR882 Dose 1, AR882 Dose 2
- Where
- 23 sites in United States, Australia and 1 more
- Volunteers
- 140 people
- Sponsor
- Arthrosi Therapeutics
Acute Gouty Arthritis
A Study to Evaluate Efficacy and Safety of Anakinra in the Treatment of Acute Gouty Arthritis
The purpose of this study is to evaluate how anakinra relieves pain for patients with acute gout that cannot take non-steroidal anti-inflammatory drugs (NSAIDs) and colchicine.
- Trial name
- anaGO (NCT03002974)
- Testing
- Anakinra 100 mg, Triamcinolone Acetonide 40 mg
- Where
- 37 sites in United States
- Volunteers
- 165 people
- Sponsor
- Swedish Orphan Biovitrum
Gout
A Single Dose Study of SHR4640 in Healthy Male Volunteers
This is a single-center, randomized, double-blind, placebo-controlled, single ascending-dose Phase I trial.
- Trial name
- NCT03015948
- Testing
- SHR4640
- Where
- Australia
- Volunteers
- 40 people, healthy volunteers welcome
- Sponsor
- Atridia Pty Ltd.
Gout
Single and Multiple Dose Study in Japanese Subjects
This study will explore the safety, tolerability, and serum uric acid lowering effect of RDEA3170 in healthy Japanese males to allow comparison with the Western population.
- Trial name
- NCT01872832
- Where
- United States
- Volunteers
- 46 people, healthy volunteers welcome
- Sponsor
- Ardea Biosciences, Inc.
Gout
PREventative Study Against URate-Lowering Drug-Induced Gout Exacerbations (PRE-SURGE 2)
The purpose of this clinical research study was to determine the safety and effectiveness of an experimental drug called rilonacept in participants with gout who are beginning allopurinol treatment for gout.
- Trial name
- NCT00958438
- Testing
- Rilonacept
- Where
- 61 sites in Germany, India and 3 more
- Volunteers
- 248 people
- Sponsor
- Regeneron Pharmaceuticals
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.
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