Clinical trials: Gout
Gout
Allopurinol Outcome Study
This is a study of allopurinol in gout patients with hyperuricemia that will evaluate the safety and serum urate (sUA) lowering capability of allopurinol as a urate lowering therapy (ULT) for up to six months.
- Trial name
- LASSO (NCT01391325)
- Testing
- Allopurinol
- Where
- 173 sites in United States, Australia and 5 more
- Volunteers
- 1,735 people
- Sponsor
- Ardea Biosciences, Inc.
Gout
Study of Pegloticase (KRYSTEXXA®) Plus Methotrexate in Patients With Uncontrolled Gout
The overall objective of the study is to assess the efficacy, safety, tolerability, and pharmacokinetics (PK) of the concomitant use of pegloticase with methotrexate (MTX) to enhance the response rate seen with pegloticase alone…
- Trial name
- MIRROR OL (NCT03635957)
- Testing
- Pegloticase, Methotrexate (MTX), Standard Gout Flare Prophylaxis
- Where
- 6 sites in United States
- Volunteers
- 14 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, Hyperuricemia
A Study to Assess Efficay and Safety of LC350189 Different Doses in Gout Patients With Hyperuricemia
The aim of this 12-week randomized multicenter double-blind parallel group placebo-controlled dose finding study is to assess the efficacy and safety of three different doses of LC350189 in subjects with hyperuricemia and a…
- Trial name
- NCT03934099
- Testing
- LC350189 formulated capsule
- Where
- 34 sites in United States
- Volunteers
- 156 people
- Sponsor
- LG Chem
Gout
Virtual Gout Clinic
The overarching goal of the investigators project is to identify best practices in gout and hyperuricemia management, translate these evidence-based practices into a highly generalizable strategy for optimal delivery of gout…
- Trial name
- NCT02790463
- Testing
- Pharmacist-Led Intervention
- Where
- 2 sites in United States
- Volunteers
- 1,463 people
- Sponsor
- University of Alabama at Birmingham
Gout
Lesinurad Monotherapy in Gout Subjects Intolerant to Xanthine Oxidase Inhibitors
This study will assess the serum uric acid lowering effects and safety of lesinurad compared to placebo in patients who are intolerant or have a contraindication to allopurinol or febuxostat.
- Trial name
- LIGHT (NCT01508702)
- Testing
- lesinurad
- Where
- 106 sites in United States, Australia and 5 more
- Volunteers
- 214 people
- Sponsor
- Ardea Biosciences, Inc.
Gout
A Trial to Investigate the Non-inferiority of Pegloticase Administered Every 4 Weeks (Q4W) With MTX Compared With Every 2 Weeks (Q2W) With MTX in Participants With Uncontrolled Refractory Gout
The study consists of 24-week double-blind trial to evaluate the non-inferiority of the efficacy and safety of pegloticase Q4W with MTX versus pegloticase Q2W with MTX, followed by a 24-week open-label extension of pegloticase…
- Trial name
- NCT06229145
- Testing
- Pegloticase, Methotrexate
- Where
- 74 sites in United States
- Volunteers
- 306 people
- Sponsor
- Amgen
Acute Gouty Arthritis
Long-Term Safety and Tolerability of Canakinumab Prefilled Syringes in Frequently Flaring Acute Gouty Arthritis Patients
This is a 36 week open-label extension of the canakinumab pre-filled syringe study for safety and tolerability in patients who have frequent flares of acute gouty arthritis.
- Trial name
- NCT01431638
- Testing
- Canakinumab 150mg in prefilled syringe
- Where
- 68 sites in United States, Canada and 2 more
- Volunteers
- 397 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
Joint Damage
Effect of Febuxostat on Joint Damage in Hyperuricemic Subjects With Early Gout
This purpose of this study is to assess the effect of febuxostat, once daily (QD), on joint damage in patients with elevated serum urate levels and gout.
- Trial name
- NCT01078389
- Testing
- Febuxostat
- Where
- 56 sites in United States
- Volunteers
- 314 people
- Sponsor
- Takeda
Gout Attack
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Evaluation of RPH-104 Administered at Different Doses to Patients With Acute Gout Attack
The primary goal of the study was to evaluate the parameters of efficacy, pharmacokinetics, pharmacodynamics, safety and tolerability of a single dose of RPH-104 in adult patients with acute gout attack.
- Trial name
- NCT04067492
- Testing
- RPH - 104, Voltaren®
- Where
- 11 sites in Russia
- Volunteers
- 47 people
- Sponsor
- R-Pharm
Gout
Pegylated Recombinant Mammalian Uricase (PEG-uricase) as Treatment for Refractory Gout
The purpose of this study is to determine whether PEG-uricase (a chemically modified recombinant mammalian enzyme that degrades uric acid) is effective in controlling hyperuricemia in patients with chronic gout, who cannot…
- Trial name
- NCT00111657
- Testing
- Pegloticase
- Where
- United States
- Volunteers
- 30 people
- Sponsor
- John Sundy
Gout
Allopurinol Versus Febuxostat in Subjects Completing the Phase 3 Trials C02-009 or C02-010
The purpose of this study is to determine the long-term safety of febuxostat, once daily (QD), compared to allopurinol in reducing serum urate levels in subjects with gout.
- Trial name
- EXCEL (NCT00175019)
- Testing
- Febuxostat, Allopurinol
- Volunteers
- 1,086 people
- Sponsor
- Takeda
Gout, Low Medication Adherence
SToRytelling to Improve DiseasE Outcomes in GOut: The STRIDE-GO2 Study
The objective is to test the efficacy of a patient-centered, culturally relevant narrative intervention, or "storytelling," based on the solid conceptual foundation of the narrative communication theory and the constructs of the…
- Conditions
- Gout, Low Medication Adherence, Health Related Quality of Life
- Trial name
- STRIDE-GO2 (NCT02741700)
- Testing
- Gout Storytelling Video Intervention
- Where
- 3 sites in United States
- Volunteers
- 306 people
- Sponsor
- VA Office of Research and Development
Gout
Efficacy and Safety of Extended Release and Immediate Release Febuxostat in Participants With Gout
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 participants with…
- Trial name
- NCT02139046
- Testing
- Febuxostat IR, Febuxostat XR, Colchicine
- Where
- 192 sites in United States
- Volunteers
- 1,790 people
- Sponsor
- Takeda
Diabetes Mellitus, Gout
Pharmacogenetics of SGLT2 Inhibitors
Sodium-dependent glucose transporter-2 (SGLT2) inhibitors are a new class of anti-diabetic drugs, which increase urinary glucose excretion thereby promoting weight loss and decreasing plasma glucose levels.
- Conditions
- Diabetes Mellitus, Gout, Hyperuricemia
- Trial name
- SGLT2iPGx (NCT02462421)
- Testing
- Canagliflozin
- Volunteers
- 30 people, healthy volunteers welcome
- Sponsor
- University of Maryland, Baltimore
Uncontrolled Gout, Kidney Transplant
Study of Pegloticase in Participants With Uncontrolled Gout Who Have Had a Kidney Transplant
The primary objective of this study is to evaluate the effect of pegloticase on the response rate of sustained serum uric acid (sUA) reduction to sUA < 6 mg/dL during Month 6 of treatment.
- Trial name
- NCT04087720
- Testing
- Pegloticase
- Where
- 8 sites in United States
- Volunteers
- 20 people
- Sponsor
- Amgen
Gout
Study of KRYSTEXXA® (Pegloticase) Plus Methotrexate in Participants With Uncontrolled Gout
The purpose of this study is to assess the potential for pegloticase with methotrexate (MTX) to increase the response rate seen with pegloticase alone, and to characterize the safety, tolerability and pharmacokinetics (PK) of the…
- Trial name
- MIRROR RCT (NCT03994731)
- Testing
- Pegloticase, methotrexate, folic acid
- Where
- 60 sites in United States
- Volunteers
- 152 people
- Sponsor
- Amgen
Chronic Uncontrolled Gout, Gout
Infusion Duration Study To Assess Tolerability of Pegloticase Administered With a Shorter Infusion Duration in Subjects With Uncontrolled Gout Receiving Methotrexate
The purpose of this study is to assess the safety, tolerability and efficiency of pegloticase administered with a shorter infusion duration in participants with uncontrolled gout receiving methotrexate.
- Conditions
- Chronic Uncontrolled Gout, Gout, Uncontrolled Gout
- Trial name
- NCT04511702
- Testing
- Pegloticase with MTX
- Where
- 39 sites in United States
- Volunteers
- 191 people
- Sponsor
- Amgen
Chronic Gout
A Study to Compare the Efficacy of SEL-212 to KRYSTEXXA® in Gout Participants Refractory to Conventional Therapy
This is a randomized, parallel-arm, multicenter study to compare the safety and efficacy profiles of SEL-212 and KRYSTEXXA®. Participants will be randomized 1:1 to receive treatment with SEL-212 or KRYSTEXXA® for 6 months.
- Trial name
- COMPARE (NCT03905512)
- Testing
- SEL-212, KRYSTEXXA®
- Where
- 43 sites in United States
- Volunteers
- 170 people
- Sponsor
- Selecta Biosciences, Inc.