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Clinical Trials List

Protocol NumberJW21301
NCT Number(ClinicalTrials.gov Identfier)NCT05815901
Active

2022-12-14 - 2026-12-31

Phase III

Recruiting13

ICD-10M10.00

Idiopathic gout, unspecified site

ICD-10M10.011

Idiopathic gout, right shoulder

ICD-10M10.012

Idiopathic gout, left shoulder

ICD-10M10.019

Idiopathic gout, unspecified shoulder

ICD-10M10.021

Idiopathic gout, right elbow

ICD-10M10.022

Idiopathic gout, left elbow

ICD-10M10.029

Idiopathic gout, unspecified elbow

ICD-10M10.031

Idiopathic gout, right wrist

ICD-10M10.032

Idiopathic gout, left wrist

ICD-10M10.039

Idiopathic gout, unspecified wrist

ICD-10M10.041

Idiopathic gout, right hand

ICD-10M10.042

Idiopathic gout, left hand

ICD-10M10.049

Idiopathic gout, unspecified hand

ICD-10M10.051

Idiopathic gout, right hip

ICD-10M10.052

Idiopathic gout, left hip

ICD-10M10.059

Idiopathic gout, unspecified hip

ICD-10M10.061

Idiopathic gout, right knee

ICD-10M10.062

Idiopathic gout, left knee

ICD-10M10.069

Idiopathic gout, unspecified knee

ICD-10M10.071

Idiopathic gout, right ankle and foot

ICD-10M10.072

Idiopathic gout, left ankle and foot

ICD-10M10.079

Idiopathic gout, unspecified ankle and foot

ICD-10M10.08

Idiopathic gout, vertebrae

ICD-10M10.09

Idiopathic gout, multiple sites

ICD-10M10.10

Lead-induced gout, unspecified site

ICD-10M10.111

Lead-induced gout, right shoulder

ICD-10M10.112

Lead-induced gout, left shoulder

ICD-10M10.119

Lead-induced gout, unspecified shoulder

ICD-10M10.121

Lead-induced gout, right elbow

ICD-10M10.122

Lead-induced gout, left elbow

ICD-10M10.129

Lead-induced gout, unspecified elbow

ICD-10M10.131

Lead-induced gout, right wrist

ICD-10M10.132

Lead-induced gout, left wrist

ICD-10M10.139

Lead-induced gout, unspecified wrist

ICD-10M10.141

Lead-induced gout, right hand

ICD-10M10.142

Lead-induced gout, left hand

ICD-10M10.149

Lead-induced gout, unspecified hand

ICD-10M10.151

Lead-induced gout, right hip

ICD-10M10.152

Lead-induced gout, left hip

ICD-10M10.159

Lead-induced gout, unspecified hip

ICD-10M10.161

Lead-induced gout, right knee

ICD-10M10.162

Lead-induced gout, left knee

ICD-10M10.169

Lead-induced gout, unspecified knee

ICD-10M10.171

Lead-induced gout, right ankle and foot

ICD-10M10.172

Lead-induced gout, left ankle and foot

ICD-10M10.179

Lead-induced gout, unspecified ankle and foot

ICD-10M10.18

Lead-induced gout, vertebrae

ICD-10M10.19

Lead-induced gout, multiple sites

ICD-10M10.20

Drug-induced gout, unspecified site

ICD-10M10.211

Drug-induced gout, right shoulder

ICD-10M10.212

Drug-induced gout, left shoulder

ICD-10M10.219

Drug-induced gout, unspecified shoulder

ICD-10M10.221

Drug-induced gout, right elbow

ICD-10M10.222

Drug-induced gout, left elbow

ICD-10M10.229

Drug-induced gout, unspecified elbow

ICD-10M10.231

Drug-induced gout, right wrist

ICD-10M10.232

Drug-induced gout, left wrist

ICD-10M10.239

Drug-induced gout, unspecified wrist

ICD-10M10.241

Drug-induced gout, right hand

ICD-10M10.242

Drug-induced gout, left hand

ICD-10M10.249

Drug-induced gout, unspecified hand

ICD-10M10.251

Drug-induced gout, right hip

ICD-10M10.252

Drug-induced gout, left hip

ICD-10M10.259

Drug-induced gout, unspecified hip

ICD-10M10.261

Drug-induced gout, right knee

ICD-10M10.262

Drug-induced gout, left knee

ICD-10M10.269

Drug-induced gout, unspecified knee

ICD-10M10.271

Drug-induced gout, right ankle and foot

ICD-10M10.272

Drug-induced gout, left ankle and foot

ICD-10M10.279

Drug-induced gout, unspecified ankle and foot

ICD-10M10.28

Drug-induced gout, vertebrae

ICD-10M10.29

Drug-induced gout, multiple sites

ICD-10M1A.00X0

Idiopathic chronic gout, unspecified site, without tophus (tophi)

ICD-10M1A.00X1

Idiopathic chronic gout, unspecified site, with tophus (tophi)

ICD-10M1A.0110

Idiopathic chronic gout, right shoulder, without tophus (tophi)

ICD-10M1A.0111

Idiopathic chronic gout, right shoulder, with tophus (tophi)

ICD-10M1A.0120

Idiopathic chronic gout, left shoulder, without tophus (tophi)

ICD-10M1A.0121

Idiopathic chronic gout, left shoulder, with tophus (tophi)

ICD-10M1A.0190

Idiopathic chronic gout, unspecified shoulder, without tophus (tophi)

ICD-10M1A.0191

Idiopathic chronic gout, unspecified shoulder, with tophus (tophi)

ICD-10M1A.0210

Idiopathic chronic gout, right elbow, without tophus (tophi)

ICD-10M1A.0211

Idiopathic chronic gout, right elbow, with tophus (tophi)

ICD-10M1A.0220

Idiopathic chronic gout, left elbow, without tophus (tophi)

ICD-10M1A.0221

Idiopathic chronic gout, left elbow, with tophus (tophi)

ICD-10M1A.0290

Idiopathic chronic gout, unspecified elbow, without tophus (tophi)

ICD-10M1A.0291

Idiopathic chronic gout, unspecified elbow, with tophus (tophi)

ICD-10M1A.0310

Idiopathic chronic gout, right wrist, without tophus (tophi)

ICD-10M1A.0311

Idiopathic chronic gout, right wrist, with tophus (tophi)

ICD-10M1A.0320

Idiopathic chronic gout, left wrist, without tophus (tophi)

ICD-10M1A.0321

Idiopathic chronic gout, left wrist, with tophus (tophi)

ICD-10M1A.0390

Idiopathic chronic gout, unspecified wrist, without tophus (tophi)

ICD-10M1A.0391

Idiopathic chronic gout, unspecified wrist, with tophus (tophi)

ICD-10M1A.0410

Idiopathic chronic gout, right hand, without tophus (tophi)

ICD-10M1A.0411

Idiopathic chronic gout, right hand, with tophus (tophi)

ICD-10M1A.0420

Idiopathic chronic gout, left hand, without tophus (tophi)

ICD-10M1A.0421

Idiopathic chronic gout, left hand, with tophus (tophi)

ICD-10M1A.0490

Idiopathic chronic gout, unspecified hand, without tophus (tophi)

ICD-10M1A.0491

Idiopathic chronic gout, unspecified hand, with tophus (tophi)

ICD-10M1A.0510

Idiopathic chronic gout, right hip, without tophus (tophi)

ICD-10M1A.0511

Idiopathic chronic gout, right hip, with tophus (tophi)

ICD-10M1A.0520

Idiopathic chronic gout, left hip, without tophus (tophi)

ICD-10M1A.0521

Idiopathic chronic gout, left hip, with tophus (tophi)

ICD-10M1A.0590

Idiopathic chronic gout, unspecified hip, without tophus (tophi)

ICD-10M1A.0591

Idiopathic chronic gout, unspecified hip, with tophus (tophi)

ICD-10M1A.0610

Idiopathic chronic gout, right knee, without tophus (tophi)

ICD-10M1A.0611

Idiopathic chronic gout, right knee, with tophus (tophi)

ICD-10M1A.0620

Idiopathic chronic gout, left knee, without tophus (tophi)

ICD-10M1A.0621

Idiopathic chronic gout, left knee, with tophus (tophi)

ICD-10M1A.0690

Idiopathic chronic gout, unspecified knee, without tophus (tophi)

ICD-10M1A.0691

Idiopathic chronic gout, unspecified knee, with tophus (tophi)

ICD-10M1A.0710

Idiopathic chronic gout, right ankle and foot, without tophus (tophi)

ICD-10M1A.0711

Idiopathic chronic gout, right ankle and foot, with tophus (tophi)

ICD-10M1A.0720

Idiopathic chronic gout, left ankle and foot, without tophus (tophi)

ICD-10M1A.0721

Idiopathic chronic gout, left ankle and foot, with tophus (tophi)

ICD-10M1A.0790

Idiopathic chronic gout, unspecified ankle and foot, without tophus (tophi)

ICD-10M1A.0791

Idiopathic chronic gout, unspecified ankle and foot, with tophus (tophi)

ICD-10M1A.08X0

Idiopathic chronic gout, vertebrae, without tophus (tophi)

ICD-10M1A.08X1

Idiopathic chronic gout, vertebrae, with tophus (tophi)

ICD-10M1A.09X0

Idiopathic chronic gout, multiple sites, without tophus (tophi)

ICD-10M1A.09X1

Idiopathic chronic gout, multiple sites, with tophus (tophi)

ICD-10M1A.20X0

Drug-induced chronic gout, unspecified site, without tophus (tophi)

ICD-10M1A.2110

Drug-induced chronic gout, right shoulder, without tophus (tophi)

ICD-10M1A.2111

Drug-induced chronic gout, right shoulder, with tophus (tophi)

ICD-10M1A.2120

Drug-induced chronic gout, left shoulder, without tophus (tophi)

ICD-10M1A.2121

Drug-induced chronic gout, left shoulder, with tophus (tophi)

ICD-10M1A.2190

Drug-induced chronic gout, unspecified shoulder, without tophus (tophi)

ICD-10M1A.2191

Drug-induced chronic gout, unspecified shoulder, with tophus (tophi)

ICD-10M1A.2210

Drug-induced chronic gout, right elbow, without tophus (tophi)

ICD-10M1A.2211

Drug-induced chronic gout, right elbow, with tophus (tophi)

ICD-10M1A.2220

Drug-induced chronic gout, left elbow, without tophus (tophi)

ICD-10M1A.2221

Drug-induced chronic gout, left elbow, with tophus (tophi)

ICD-10M1A.2290

Drug-induced chronic gout, unspecified elbow, without tophus (tophi)

ICD-10M1A.2291

Drug-induced chronic gout, unspecified elbow, with tophus (tophi)

ICD-10M1A.2310

Drug-induced chronic gout, right wrist, without tophus (tophi)

ICD-10M1A.2311

Drug-induced chronic gout, right wrist, with tophus (tophi)

ICD-10M1A.2320

Drug-induced chronic gout, left wrist, without tophus (tophi)

ICD-10M1A.2321

Drug-induced chronic gout, left wrist, with tophus (tophi)

ICD-10M1A.2390

Drug-induced chronic gout, unspecified wrist, without tophus (tophi)

ICD-10M1A.2391

Drug-induced chronic gout, unspecified wrist, with tophus (tophi)

ICD-10M1A.2410

Drug-induced chronic gout, right hand, without tophus (tophi)

ICD-10M1A.2411

Drug-induced chronic gout, right hand, with tophus (tophi)

ICD-10M1A.2420

Drug-induced chronic gout, left hand, without tophus (tophi)

ICD-10M1A.2421

Drug-induced chronic gout, left hand, with tophus (tophi)

ICD-10M1A.2490

Drug-induced chronic gout, unspecified hand, without tophus (tophi)

ICD-10M1A.2491

Drug-induced chronic gout, unspecified hand, with tophus (tophi)

ICD-10M1A.2510

Drug-induced chronic gout, right hip, without tophus (tophi)

ICD-10M1A.2511

Drug-induced chronic gout, right hip, with tophus (tophi)

ICD-10M1A.2520

Drug-induced chronic gout, left hip, without tophus (tophi)

ICD-10M1A.2521

Drug-induced chronic gout, left hip, with tophus (tophi)

ICD-10M1A.2590

Drug-induced chronic gout, unspecified hip, without tophus (tophi)

ICD-10M1A.2591

Drug-induced chronic gout, unspecified hip, with tophus (tophi)

ICD-10M1A.2610

Drug-induced chronic gout, right knee, without tophus (tophi)

ICD-10M1A.2611

Drug-induced chronic gout, right knee, with tophus (tophi)

ICD-10M1A.2620

Drug-induced chronic gout, left knee, without tophus (tophi)

ICD-10M1A.2621

Drug-induced chronic gout, left knee, with tophus (tophi)

ICD-10M1A.2690

Drug-induced chronic gout, unspecified knee, without tophus (tophi)

ICD-10M1A.2691

Drug-induced chronic gout, unspecified knee, with tophus (tophi)

ICD-10M1A.2710

Drug-induced chronic gout, right ankle and foot, without tophus (tophi)

ICD-10M1A.2711

Drug-induced chronic gout, right ankle and foot, with tophus (tophi)

ICD-10M1A.2720

Drug-induced chronic gout, left ankle and foot, without tophus (tophi)

ICD-10M1A.2721

Drug-induced chronic gout, left ankle and foot, with tophus (tophi)

ICD-10M1A.2790

Drug-induced chronic gout, unspecified ankle and foot, without tophus (tophi)

ICD-10M1A.2791

Drug-induced chronic gout, unspecified ankle and foot, with tophus (tophi)

ICD-10M1A.28X0

Drug-induced chronic gout, vertebrae, without tophus (tophi)

ICD-10M1A.28X1

Drug-induced chronic gout, vertebrae, with tophus (tophi)

ICD-10M1A.29X0

Drug-induced chronic gout, multiple sites, without tophus (tophi)

ICD-10M1A.29X1

Drug-induced chronic gout, multiple sites, with tophus (tophi)

ICD-10M1A.30X0

Chronic gout due to renal impairment, unspecified site, without tophus (tophi)

ICD-10M1A.3110

Chronic gout due to renal impairment, right shoulder, without tophus (tophi)

ICD-10M1A.3111

Chronic gout due to renal impairment, right shoulder, with tophus (tophi)

ICD-10M1A.3120

Chronic gout due to renal impairment, left shoulder, without tophus (tophi)

ICD-10M1A.3121

Chronic gout due to renal impairment, left shoulder, with tophus (tophi)

ICD-10M1A.3190

Chronic gout due to renal impairment, unspecified shoulder, without tophus (tophi)

ICD-10M1A.3191

Chronic gout due to renal impairment, unspecified shoulder, with tophus (tophi)

ICD-10M1A.3210

Chronic gout due to renal impairment, right elbow, without tophus (tophi)

ICD-10M1A.3211

Chronic gout due to renal impairment, right elbow, with tophus (tophi)

ICD-10M1A.3220

Chronic gout due to renal impairment, left elbow, without tophus (tophi)

ICD-10M1A.3221

Chronic gout due to renal impairment, left elbow, with tophus (tophi)

ICD-10M1A.3290

Chronic gout due to renal impairment, unspecified elbow, without tophus (tophi)

ICD-10M1A.3291

Chronic gout due to renal impairment, unspecified elbow, with tophus (tophi)

ICD-10M1A.3310

Chronic gout due to renal impairment, right wrist, without tophus (tophi)

ICD-10M1A.3311

Chronic gout due to renal impairment, right wrist, with tophus (tophi)

ICD-10M1A.3320

Chronic gout due to renal impairment, left wrist, without tophus (tophi)

ICD-10M1A.3321

Chronic gout due to renal impairment, left wrist, with tophus (tophi)

ICD-10M1A.3390

Chronic gout due to renal impairment, unspecified wrist, without tophus (tophi)

ICD-10M1A.3391

Chronic gout due to renal impairment, unspecified wrist, with tophus (tophi)

ICD-10M1A.3410

Chronic gout due to renal impairment, right hand, without tophus (tophi)

ICD-10M1A.3411

Chronic gout due to renal impairment, right hand, with tophus (tophi)

ICD-10M1A.3420

Chronic gout due to renal impairment, left hand, without tophus (tophi)

ICD-10M1A.3421

Chronic gout due to renal impairment, left hand, with tophus (tophi)

ICD-10M1A.3490

Chronic gout due to renal impairment, unspecified hand, without tophus (tophi)

ICD-10M1A.3491

Chronic gout due to renal impairment, unspecified hand, with tophus (tophi)

ICD-10M1A.3510

Chronic gout due to renal impairment, right hip, without tophus (tophi)

ICD-10M1A.3511

Chronic gout due to renal impairment, right hip, with tophus (tophi)

ICD-10M1A.3520

Chronic gout due to renal impairment, left hip, without tophus (tophi)

ICD-10M1A.3521

Chronic gout due to renal impairment, left hip, with tophus (tophi)

ICD-10M1A.3590

Chronic gout due to renal impairment, unspecified hip, without tophus (tophi)

ICD-10M1A.3591

Chronic gout due to renal impairment, unspecified hip, with tophus (tophi)

ICD-10M1A.3610

Chronic gout due to renal impairment, right knee, without tophus (tophi)

ICD-10M1A.3611

Chronic gout due to renal impairment, right knee, with tophus (tophi)

ICD-10M1A.3620

Chronic gout due to renal impairment, left knee, without tophus (tophi)

ICD-10M1A.3621

Chronic gout due to renal impairment, left knee, with tophus (tophi)

ICD-10M1A.3690

Chronic gout due to renal impairment, unspecified knee, without tophus (tophi)

ICD-10M1A.3691

Chronic gout due to renal impairment, unspecified knee, with tophus (tophi)

ICD-10M1A.3710

Chronic gout due to renal impairment, right ankle and foot, without tophus (tophi)

ICD-10M1A.3711

Chronic gout due to renal impairment, right ankle and foot, with tophus (tophi)

ICD-10M1A.3720

Chronic gout due to renal impairment, left ankle and foot, without tophus (tophi)

ICD-10M1A.3721

Chronic gout due to renal impairment, left ankle and foot, with tophus (tophi)

ICD-10M1A.3790

Chronic gout due to renal impairment, unspecified ankle and foot, without tophus (tophi)

ICD-10M1A.3791

Chronic gout due to renal impairment, unspecified ankle and foot, with tophus (tophi)

ICD-10M1A.38X0

Chronic gout due to renal impairment, vertebrae, without tophus (tophi)

ICD-10M1A.38X1

Chronic gout due to renal impairment, vertebrae, with tophus (tophi)

ICD-10M1A.39X0

Chronic gout due to renal impairment, multiple sites, without tophus (tophi)

ICD-10M1A.39X1

Chronic gout due to renal impairment, multiple sites, with tophus (tophi)

ICD-10M1A.40X0

Other secondary chronic gout, unspecified site, without tophus (tophi)

ICD-10M1A.4110

Other secondary chronic gout, right shoulder, without tophus (tophi)

ICD-10M1A.4111

Other secondary chronic gout, right shoulder, with tophus (tophi)

ICD-10M1A.4120

Other secondary chronic gout, left shoulder, without tophus (tophi)

ICD-10M1A.4121

Other secondary chronic gout, left shoulder, with tophus (tophi)

ICD-10M1A.4190

Other secondary chronic gout, unspecified shoulder, without tophus (tophi)

ICD-10M1A.4191

Other secondary chronic gout, unspecified shoulder, with tophus (tophi)

ICD-10M1A.4210

Other secondary chronic gout, right elbow, without tophus (tophi)

ICD-10M1A.4211

Other secondary chronic gout, right elbow, with tophus (tophi)

ICD-10M1A.4220

Other secondary chronic gout, left elbow, without tophus (tophi)

ICD-10M1A.4221

Other secondary chronic gout, left elbow, with tophus (tophi)

ICD-10M1A.4290

Other secondary chronic gout, unspecified elbow, without tophus (tophi)

ICD-10M1A.4291

Other secondary chronic gout, unspecified elbow, with tophus (tophi)

ICD-10M1A.4310

Other secondary chronic gout, right wrist, without tophus (tophi)

ICD-10M1A.4311

Other secondary chronic gout, right wrist, with tophus (tophi)

ICD-10M1A.4320

Other secondary chronic gout, left wrist, without tophus (tophi)

ICD-10M1A.4321

Other secondary chronic gout, left wrist, with tophus (tophi)

ICD-10M1A.4390

Other secondary chronic gout, unspecified wrist, without tophus (tophi)

ICD-10M1A.4391

Other secondary chronic gout, unspecified wrist, with tophus (tophi)

ICD-10M1A.4410

Other secondary chronic gout, right hand, without tophus (tophi)

ICD-10M1A.4411

Other secondary chronic gout, right hand, with tophus (tophi)

ICD-10M1A.4420

Other secondary chronic gout, left hand, without tophus (tophi)

ICD-10M1A.4421

Other secondary chronic gout, left hand, with tophus (tophi)

ICD-10M1A.4490

Other secondary chronic gout, unspecified hand, without tophus (tophi)

ICD-10M1A.4491

Other secondary chronic gout, unspecified hand, with tophus (tophi)

ICD-10M1A.4510

Other secondary chronic gout, right hip, without tophus (tophi)

ICD-10M1A.4511

Other secondary chronic gout, right hip, with tophus (tophi)

ICD-10M1A.4520

Other secondary chronic gout, left hip, without tophus (tophi)

ICD-10M1A.4521

Other secondary chronic gout, left hip, with tophus (tophi)

ICD-10M1A.4590

Other secondary chronic gout, unspecified hip, without tophus (tophi)

ICD-10M1A.4591

Other secondary chronic gout, unspecified hip, with tophus (tophi)

ICD-10M1A.4610

Other secondary chronic gout, right knee, without tophus (tophi)

ICD-10M1A.4611

Other secondary chronic gout, right knee, with tophus (tophi)

ICD-10M1A.4620

Other secondary chronic gout, left knee, without tophus (tophi)

ICD-10M1A.4621

Other secondary chronic gout, left knee, with tophus (tophi)

ICD-10M1A.4690

Other secondary chronic gout, unspecified knee, without tophus (tophi)

ICD-10M1A.4691

Other secondary chronic gout, unspecified knee, with tophus (tophi)

ICD-10M1A.4710

Other secondary chronic gout, right ankle and foot, without tophus (tophi)

ICD-10M1A.4711

Other secondary chronic gout, right ankle and foot, with tophus (tophi)

ICD-10M1A.4720

Other secondary chronic gout, left ankle and foot, without tophus (tophi)

ICD-10M1A.4721

Other secondary chronic gout, left ankle and foot, with tophus (tophi)

ICD-10M1A.4790

Other secondary chronic gout, unspecified ankle and foot, without tophus (tophi)

ICD-10M1A.4791

Other secondary chronic gout, unspecified ankle and foot, with tophus (tophi)

ICD-10M1A.48X0

Other secondary chronic gout, vertebrae, without tophus (tophi)

ICD-10M1A.48X1

Other secondary chronic gout, vertebrae, with tophus (tophi)

ICD-10M1A.49X0

Other secondary chronic gout, multiple sites, without tophus (tophi)

ICD-10M1A.49X1

Other secondary chronic gout, multiple sites, with tophus (tophi)

ICD-10M1A.9XX0

Chronic gout, unspecified, without tophus (tophi)

ICD-10M1A.9XX1

Chronic gout, unspecified, with tophus (tophi)

ICD-9274.0

Gouty arthropathy

A Multi-center, Randomized, Double-blind, Active-controlled, Therapeutic Confirmatory, Phase III Study to Compare and Evaluate the Efficacy and Safety of Epaminurad With Febuxostat in Gout Patients

  • Sponsor

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/02/01

Investigators and Locations

Principal Investigator 陳宏安

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

The Actual Total Number of Participants Enrolled

0 Recruiting

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 林孝義 Division of Rheumatology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

The Actual Total Number of Participants Enrolled

0 Recruiting

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chung-Ming Huang 風濕免疫科

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳正欽 Division of Rheumatology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 賴寧生

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Chi-Ching Chang

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 陳嘉夆醫師 Division of Rheumatology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 朱志勳醫師 Division of Endocrinology

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator Yi-Ching Yang

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Condition/Disease

Gout

Objectives

Epaminurad tablets are an investigational drug currently undergoing clinical trials. There is currently no regulatory body approving its widespread use. Seven clinical trials, including Phase 1 and Phase 2 trials, have been conducted in healthy adults, adults with renal insufficiency, and adults with gout to evaluate the safety and efficacy of epaminurad tablets. This Phase 3 trial aims to confirm its effect on lowering serum uric acid and the safety of epaminurad tablets in patients with gout compared to febuxostat.

Test Drug

錠劑

Active Ingredient

Epaminurad

Dosage Form

110

Dosage

6mg and 9mg / tablet

Endpoints

Based on the reduction of serum uric acid (sUA) in gout patients, epaminurad tablets (hereinafter referred to as "epaminurad") were evaluated as non-inferior to febuxostat.

Inclution Criteria

Inclusion Criteria:

for screening

≥19 to ≤75 years of age at the time of written informed consent
Diagnosed record with gout, or ACR/EULAR 2015 score ≥8
Able and willing to actively participate in TLC programme
Signed ICF for voluntary study participation
for randomization

sUA level ≥7.0 mg/dL
ACR/EULAR 2015 score ≥8

Exclusion Criteria

Exclusion Criteria:

Medical history

Malignant tumor, Urolithiasis within 5 years, Hypersensitivity disease, Lesch-Nyhan syndrome, Hereditary problems, Ischemic heart disease, Prior or planned organ transplant recipient.

Concurrent disease or laboratory test abnormality

Uncontrolled diabetes mellitus, Uncontrolled hypertension, Uncontrolled dyslipidemia, AST or ALT ≥2×ULN, total bilirubin ≥1.5×ULN, eGFR <30 mL/min/1.73m^2, Uncontrolled thyroid dysfunction, HIV, HBV or HCV positive, Drug and alcohol abuse, BMI ≥40 kg/m^2

History of gout flare between 2 weeks before written informed consent and immediately before randomization
Any cardiovascular abnormalities that might affect the study
Prior or planned treatment with xanthine oxidase inhibitors, uricosuric agents, or uricolytic agents
Prior or planned treatment with drugs acting on human uric acid transporter 1 or diuretics
Prior or planned treatment with intravenous and oral high dose systemic corticosteroids, mercaptopurine, azathioprine, or theophylline
Hypersensitivity to the IP (epaminurad or febuxostat)
Pregnant or lactating woman.

The Estimated Number of Participants

  • Taiwan

    206 participants

  • Global

    588 participants