Efficacy and Safety of Simiaowan in Prevention of Acute Flares in Chronic Gout Patients Initiating Febuxostat Therapy
NCT ID: NCT04069325
Last Updated: 2019-08-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
72 participants
INTERVENTIONAL
2019-09-01
2020-07-28
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
PREVENTION
TRIPLE
Study Groups
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simiaowan 6g + febuxostat 40mg
simiaowan
pills, 6g twice daily (BID), oral, 12 weeks
febuxostat
tablets, 40 mg once daily (QD), oral, 12 weeks
placebo 6g + febuxostat 40mg
placebo
pills, 6g twice daily (BID), oral, 12 weeks
febuxostat
tablets, 40 mg once daily (QD), oral, 12 weeks
Interventions
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simiaowan
pills, 6g twice daily (BID), oral, 12 weeks
placebo
pills, 6g twice daily (BID), oral, 12 weeks
febuxostat
tablets, 40 mg once daily (QD), oral, 12 weeks
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
75 Years
ALL
No
Sponsors
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Affiliated Hospital of Nanjing University of Chinese Medicine
OTHER
The Second Affiliated Hospital of Dalian Medical University
OTHER
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
OTHER
Responsible Party
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Quan Jiang
Director, Devision of Rheumatology
Principal Investigators
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Jiang Quan, Doctor
Role: PRINCIPAL_INVESTIGATOR
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
Locations
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Guang'anmen Hospital
Beijing, Beijing Municipality, China
Countries
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Central Contacts
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Facility Contacts
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Quan Jiang, Doctor
Role: primary
Other Identifiers
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WD-18-F02
Identifier Type: -
Identifier Source: org_study_id