Efficacy and Safety of Simiaowan in Prevention of Acute Flares in Chronic Gout Patients Initiating Febuxostat Therapy

• Male or female subjects aged 18 to 75 years (time of get informed consent)
• Meet the American College of Rheumatology/The European League Against Rheumatism criteria (2015) for the classification of acute arthritis of primary gout
• Pain Visual Analogue Scale Score (VAS) ≤ 3 at screening
• Serum uric acid ≥7 mg/dL (420μmol/L) at screening
• Self-reported history of at least 2 gout flares within 12 months prior to screening
• Normal electrocardiogram (ECG), or no clinical significant at screening
• Be capable of understanding and complying with protocol requirements

Exclusion Criteria:

• Occurrence of an acute gout flare ongoing at screening or within 2 weeks prior to screening
• Known or suspected of secondary hyperuricemia (e.g. due to renal disorder, hematological disorder, drugs, radiotherapy, chemotherapy or organ transplant)
• Use of colchicine, allopurinol, probenecid, benzbromarone, febuxostat or history of intra-articular steroid injection within 4 weeks prior to screening
• Use of glucocorticoids, nonsteroidal antiinflammatory drugs (NSAIDs), or cyclooxygenase-2 (COX-2) inhibitors within 1 week prior to screening
• History of stroke, transient ischemic attack (TIA), acute myocardial infarction (MI), heart failure (NYHA Class II-IV), coronary intervention procedure (including but not limited to angioplasty, stent placement, coronary revascularization) prior to screening
• History of gastrointestinal (GI) bleeding, peptic ulcer disease prior to screening
• History of malignancy and/or mental disorder prior to screening
• Active infection with hepatitis B, hepatitis C, or has aspartate transaminase (AST), alanine aminotransferase (ALT) or gamma-glutamyl transpeptidase (GGT) values ≥1.2 times the upper limit of normal (×ULN) during the screening period
• Presence of severe renal function impairment, or has serum creatinine (sCr) values ≥1.2 (×ULN) during the screening period
• History of allergy or intolerance to febuxostat, diclofenac sodium, simiaowan and/or the placebo
• History of aspirin-induced asthma, or any other form of allergy to aspirin and other NSAIDs
• Other (non-gout) chronic arthritis, acute inflammatory arthritis, autoimmune diseases with arthritis at screening
• Being treated with simiaowan at screening
• Being treated with azathioprine, mercaptopurine, theophylline, cytotoxic agents at screening
• Diagnosis of drug or alcohol dependence or abuse or any condition requiring chronic daily use of pain medication
• Pregnant or nursing, or planning to become pregnant or father a child within 3 months after receiving the last dose of study drug
• Subjects who participated in another clinical study or clinical trial within 3 months prior to screening
• Any other condition(s) that will compromise the safety of the patient, prevent compliance with the study protocol, or compromise the quality of the clinical study, as judged by the investigator