Treatment Trials

54 Clinical Trials for Various Conditions

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Placebo Controlled, Dose Escalation Study to Evaluate Safety, Pharmacokinetics & Efficacy of SAP-001 in Gout Patients
Description

This is a Phase I, Multicenter, Randomized, Double-blind, Placebo controlled, Dose-escalation study to evaluate Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of SAP-001 in Gout Patients with Hyperuricemia. The study will be single dose ascending cohorts across three doses with a placebo control arm.

Conditions

Gout, Hyperuricemia

Phase IIa Study of ALLN-346 (Engineered Urate Oxidase) in Subjects With Hyperuricemia, Gout and Chronic Kidney Disease
Description

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

Genetics of Hyperuricemia Therapy in Hmong
Description

To pursue this objective, we will be measuring uric acid at baseline and post 14 days of twice daily allopurinol therapy in 30 Hmong participants with documented gout or hyperuricemia and known genotype for key renal transporters of uric acid.

Conditions

Hyperuricemia, Gout

Study to Evaluate sUA-Lowering Activity, Safety & PK Interaction of Oral BCX4208 & Allopurinol Admin. in Subjects w/Gout
Description

To evaluate safety and efficacy of BCX4208 alone and in combination with allopurinol in subjects with gout.

Conditions

Gout

Open Label PK, PD and DDI of Dotinurad and Allopurinol in Gout Patients with Hyperuricemia
Description

A open label multi-center 3-period multidose, PK/PD and drug-drug interaction (DDI) study to evaluate the pharmacokinetics (PK) and pharmacodynamics (PD) of 7 days of treatment with two doses of dotinurad monotherapy, and to evaluate the effect of dotinurad, as monotherapy and in combination with allopurinol, versus allopurinol monotherapy, on the PK of each, and to assess the additive PD effects on serum uric acid and urinary urate excretion in U.S. patients with gout and hyperuricemia

Conditions

Gout, Hyperuricemia

A Study to Assess Efficay and Safety of LC350189 Different Doses in Gout Patients With Hyperuricemia
Description

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 diagnosis of gout.

Conditions

Gout, Hyperuricemia

Study of Levotofisopam 50 mg Three Times a Day (TID) Administered for 7 Days on Hyperuricemia and Gout
Description

The purpose of this study is to determine whether levotofisopam is safe and effective in the treatment of hyperuricemia and gout.

Conditions

Hyperuricemia, Gout

Open Label Safety/Efficacy Study of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Gout Patients
Description

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.

Conditions

Hyperuricemia, Gout

Evaluate the PK, PD, and Safety of Arhalofenate in Combination With Febuxostat for Hyperuricemia in Patients With Gout
Description

The purpose of this study is to evaluate pharmacokinetics, pharmacodynamics, safety and potential for drug-drug interaction of arhalofenate when combined with febuxostat in adult population with gout.

Conditions

Gout, Hyperuricemia

Safety and Efficacy Study of MBX-102 in Treatment of Hyperuricemia in Patients With Gout
Description

The purpose of the study is to evaluate the safety and effectiveness of MBX-102 compared to placebo when given orally once daily for 4 weeks for the treatment of hyperuricemia in patients with gout.

Conditions

Hyperuricemia, Gout

Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-301)
Description

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

Phase 3 Evaluation of Efficacy and Safety of AR882 in Gout Patients (AR882-302)
Description

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

Study of Dapansutrile Tablets in Subjects With an Acute Gout Flare
Description

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, Gout, Arthritis, Joint Pain

Tigulixostat, Phase 3 Study, Allopurinol Controlled in Gout Patients
Description

The aim of this 12-month randomized multi-regional double-blind parallel group allopurinol and 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

Tigulixostat, Phase 3 Study, Placebo Controlled in Gout Patients
Description

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

Phase 2 to Assess Efficacy and Safety in AR882 Alone or in Combination with Allopurinol in Patients with Tophaceous Gout
Description

This study will assess the serum urate lowering effect, tophi reduction, and safety of AR882 alone and in combination with allopurinol in patients with tophaceous gout at two doses compared to allopurinol over 24 weeks.

Conditions

Gout, Arthritis, Gouty, Hyperuricemia, Gout Chronic

Phase 2b Evaluation of Efficacy and Safety of AR882 in Gout Patients
Description

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

Hmong Microbiome ANd Gout, Obesity, Vitamin C (HMANGO-C)
Description

Investigators seek to quantify the impact of vitamin C on patient outcomes, including serum urate level, gout-related symptoms, and obesity (measured by BMI) in both healthy Hmong adults and in Hmong patients with hyperuricemia (HU) and/or gout; identify associations between individuals' taxonomic and functional patterns of gut microbiota and its impact on the serum urate-lowering effect of vitamin C; compare taxonomic and functional patterns of gut microbiota between people with HU and/or gout and people without HU and gout; and identify associations between individuals' taxonomic and functional patterns of gut microbiota and self-reported acute gout trigger foods.

Conditions

Hyperuricemia, Gout

Placebo Controlled, Multiple Dose Study to Evaluate Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAP-001 in Gout Patients
Description

This is a Phase II, Multicenter, Randomized, Double-blind, Placebo controlled, Multiple Dose study to evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of SAP-001 in Gout Patients with Hyperuricemia.

Conditions

Gout, Hyperuricemia

The Diet Gout Trial
Description

Unhealthy diet has long been associated with high uric acid levels and gout. The DASH diet may lower uric acid levels. This study will examine the effects of the DASH diet on uric acid in adults with a history of gout.

Conditions

Gout, Hyperuricemia

Multi-Dose Safety/Pharmacodynamic Study of SEL-212/SEL-037 in Subjects With Symptomatic Gout & Elevated Blood Uric Acid
Description

This is an open label multicenter study to evaluate the safety and tolerability of multiple doses (3 monthly IV infusions) of SEL-212 ( a combination of pegsiticase (SEL-037) and SVP-rapamycin (SEL-110)) followed by multiple doses (2 monthly IV infusions) of pegsiticase (SEL-037) alone for a total of 5 treatment cycles in subjects with symptomatic gout and hyperuricemia. Additional participants will be treated with multiple doses ( 5 monthly IV infusions) of pegsiticase (SEL-037) alone. Participants will be monitored for safety endpoints through the 5th treatment cycle plus 30 days .Pharmacokinetic samples will be drawn at pre-determined time points in addition to weekly serum uric acid levels.

Conditions

Gout Chronic, Hyperuricemia

Efficacy, Safety And Tolerability Of PF-06743649 In Gout Subjects.
Description

The purpose of the study is to assess the effect of PF-06743649 in lowering serum uric acid in subjects suffering from gout following 14 days of dosing, as well as assessing safety and tolerability.

Conditions

Gout

Effects of Hyperuricemia Reversal on Features of the Metabolic Syndrome
Description

This study is being done to evaluate whether the medication, febuxostat, can improve the degree of insulin resistance and other features of the metabolic syndrome (high blood pressure, elevated insulin levels, excess body fat around the waist, and/or high cholesterol) by lowering uric acid levels in the blood.

Conditions

Gout

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
Description

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, Renal Insufficiency

Safety/Efficacy Study to Evaluate of MBX-102 in Combination With Allopurinol in Gout Patients
Description

The purpose of this study is to evaluate the efficacy, safety and tolerability of MBX-102 in combination with allopurinol compared to allopurinol alone when administered orally once a day for four weeks to gout patients with an inadequate hypouricemic response to allopurinol alone.

Conditions

Gout

Tranilast Plus Allopurinol in Patients With Moderate to Severe Gout (TAnGO)
Description

This Phase 2 study will be a multicenter, double-blind, randomized, active-comparator study to evaluate the safety and efficacy of tranilast in combination with allopurinol in patients with hyperuricemia and moderate to severe gout.

Conditions

Moderate to Severe Gout, Hyperuricemia

Cardiovascular Safety of Febuxostat and Allopurinol in Participants With Gout and Cardiovascular Comorbidities (CARES)
Description

The purpose of this study is to see whether subjects with gout who receive febuxostat or allopurinol for up to 9 years have a higher rate of serious heart and blood vessel complications (major cardiovascular events).

Conditions

Cardiovascular Disease

Effect of Febuxostat on Renal Function in Patients With Gout and Moderate to Severe Renal Impairment
Description

The purpose of this study is to determine the effect of febuxostat, once daily (QD) or twice daily (BID), on renal function in gout patients with elevated serum urate levels and who have moderate to severe renal impairment.

Conditions

Renal Impairment

Effect of Febuxostat on Joint Damage in Hyperuricemic Subjects With Early Gout
Description

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.

Conditions

Joint Damage

Study of Tranilast Alone or in Combination With Allopurinol in Subjects With Hyperuricemia
Description

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 pharmacokinetics (PK) and pharmacodynamics (PD) and to evaluate the effect of allopurinol on tranilast PK and PD as measured by reduction in serum uric acid levels.

Conditions

Gout, Hyperuricemia