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

The aim of this study is to evaluate the efficacy and safety of simiaowan in prevention of acute flares in chronic gout patients initiating febuxostat therapy.

The study is a multicenter, randomized, double-blind, placebo-controlled, 12-week trial. To determine whether oral simiaowan at standard clinical doses (6g twice daily), compared to placebo, can reduce the incidence of acute gout flares and decrease the serum uric acid level.

Eligibility Criteria:
Inclusion Criteria:

* 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