Gout
Conditions
Brief summary
This study will assess the serum uric acid lowering effects and safety of SHR4640 compared to Allopurinol in subjects with gout.
Interventions
DRUGSHR4640
SHR4640 Dose 1 ,tablets, QD
DRUGAllopurinol
Allopurinol 300mg, tablets, QD
Sponsors
Jiangsu HengRui Medicine Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Intervention model description
To evaluate the efficacy and safety of SHR4640 monotherapy tablets in patients with gout
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Subject who met 1977 or 2015 ACR (American College of Rheumatology) classification of Gout and has a serum acid ≥ 480 μmol/L at screening; 2、18 kg/m2 ≤ Body mass index (BMI) ≤ 35 kg/m2.
Exclusion criteria
1. Subject who is pregnant or breastfeeding; 2. Alanine aminotransferase or Aspartate aminotransferase or total bilirubin\>1.5 upper normal limit; 3. Subject with a positive test for HLA-B\*5801; 4. Estimated glomerular filtration rate (MDRD formula) \<60ml/min; 5. HbA1c≥8%; 6. Subject with known hypersensitivity or allergy to SHR4640 and allopurinol, or any component of SHR4640; 7. Subject with kidney stones or suspicion of kidney stones; 8. Subject who has acute gout flares within 2 weeks before randomization; 9. Subject with a history of malignancy within the previous 5 years; 10. Subject with a history of active peptic ulcer within a year; 11. Subject with a history of xanthine urine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of subjects with a serum uric acid level≤360 μmol/L | Start of Treatment to end of study (approximately 16 weeks) |
Secondary
| Measure | Time frame |
|---|---|
| Percentage change of serum uric acid from baseline at each visit within 52 weeks of treatment | Start of Treatment to end of study (approximately 52 weeks) |
| Percentage change in serum uric acid from baseline at each visit during 16 weeks of treatment | Start of Treatment to end of study (approximately 16 weeks) |
| Absolute changes in serum uric acid from baseline at each visit during 16 weeks of treatment | Start of Treatment to end of study (approximately 16 weeks) |
| The proportion of subjects with A serum uric acid level≤ 360 μmol/L at each visit within 16 weeks of treatment | Start of Treatment to end of study (approximately 16 weeks) |
| proportion of subjects with serum uric acid ≤ 360 μmol/L at each visit within 52 weeks of treatment | Start of Treatment to end of study (approximately 52 weeks) |
| serum uric acid value at each visit within 52 weeks of treatment | Start of Treatment to end of study (approximately 52 weeks) |
| change value of serum uric acid from baseline at each visit within 52 weeks of treatment | Start of Treatment to end of study (approximately 52 weeks) |
Countries
China
Outcome results
None listed