Overview

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

Status:
Unknown status
Trial end date:
2020-07-28
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
N/A
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Collaborators:
Shenzhen Traditional Chinese Medicine Hospital
The Second Affiliated Hospital of Dalian Medical University
Treatments:
Febuxostat
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