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

Gout Flare Clinical Trial

Official title:

Efficacy and Safety of Simiaowan in Prevention of Acute Flares in Chronic Gout Patients Initiating Febuxostat Therapy：a Randomized Controlled Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04069325
• Other study ID #: WD-18-F02
• Status: Not yet recruiting
• Phase: N/A
• Start date: September 1, 2019
• Est. completion date: July 28, 2020

Study information

• Verified date: August 2019
• Source: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Contact: Jiang Quan, Doctor
• Phone: 86-010-88001132
• Email: doctorjq[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Description:

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 72
• Est. completion date: July 28, 2020
• Est. primary completion date: July 28, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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

Related Conditions & MeSH terms

• Gout
• Gout Flare

Intervention

Drug:
• 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

Locations

Country	Name	City	State
China	Guang'anmen Hospital	Beijing	Beijing

Sponsors (3)

Lead Sponsor	Collaborator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences	Shenzhen Traditional Chinese Medicine Hospital, The Second Affiliated Hospital of Dalian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of subjects experiencing = 1 gout flare within 12 weeks	Proportion of subjects in each group who experiencing at least 1 new gout flare during the 12 weeks study treatment period.	Day 1 to Week 12
Secondary	The incidence of new gout flares within 12 weeks in the simiaowan group compared to the placebo group	For each new flare, subjects will be asked to record in their patient diary. The total incidence of new gout flares is reported during the 12-week study treatment period.	Day 1 to Week 12
Secondary	Proportion of subjects in each group achieving serum uric acid concentration= 7 mg/dL (420µmol/L)		Week4, Week 8 and Week 12
Secondary	Proportion of subjects experiencing from = 1 gout flare and = 2 gout flares within 12 weeks		Day 1 to Week 12
Secondary	Mean pain Visual Analogue Scale Score (VAS) associated with gout flares	Subjects who experience an acute gout flare within 12 weeks will be asked to score their pain intensity in the most affected joint on a 0-10 mm Visual Analogue Scale Score (VAS), ranging from no pain (0) to extremely pain (10).	Day 1 to Week 12
Secondary	Amount of rescue medication taken within 12 weeks	Subjects who have difficulty in tolerating the pain of an acute gout flare will be allowed to take rescue medication (diclofenac sodium, 25mg, three times daily).	Day 1 to Week 12