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

NCT04069325 | Unknown DMC

• 1 other identifier: WD-18-F02
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Gout Flare

Keywords

gout; acute flares; prevention; febuxostat

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• The incidence of new gout flares within 12 weeks in the simiaowan group compared to the placebo group

  Day 1 to Week 12

• Proportion of subjects in each group achieving serum uric acid concentration≤ 7 mg/dL (420μmol/L)

  Week4, Week 8 and Week 12

• Proportion of subjects experiencing from ≥ 1 gout flare and ≥ 2 gout flares within 12 weeks

  Day 1 to Week 12

• Mean pain Visual Analogue Scale Score (VAS) associated with gout flares

  Day 1 to Week 12

• Amount of rescue medication taken within 12 weeks

  Day 1 to Week 12

Study Arms (2)

simiaowan 6g + febuxostat 40mg

EXPERIMENTAL

Drug: simiaowan; Drug: febuxostat

placebo 6g + febuxostat 40mg

PLACEBO COMPARATOR

Drug: placebo; Drug: febuxostat

Interventions

simiaowan DRUG

pills, 6g twice daily (BID), oral, 12 weeks

simiaowan 6g + febuxostat 40mg

placebo DRUG

pills, 6g twice daily (BID), oral, 12 weeks

placebo 6g + febuxostat 40mg

febuxostat DRUG

tablets, 40 mg once daily (QD), oral, 12 weeks

placebo 6g + febuxostat 40mg; simiaowan 6g + febuxostat 40mg

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Guang'anmen Hospital of China Academy of Chinese Medical Sciences: lead
• Affiliated Hospital of Nanjing University of Chinese Medicine: collaborator
• The Second Affiliated Hospital of Dalian Medical University: collaborator

Study Sites (1)

Guang'anmen Hospital

Beijing, Beijing Municipality, 100053, China

Location

MeSH Terms

Conditions

Gout

Interventions

simiaowan; Febuxostat

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Crystal Arthropathies; Rheumatic Diseases; Purine-Pyrimidine Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Thiazoles; Sulfur Compounds; Organic Chemicals; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Study Officials

• Jiang Quan, Doctor

  Guang'anmen Hospital of China Academy of Chinese Medical Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jiang Quan, Doctor

CONTACT

86-010-88001132; doctorjq@126.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Devision of Rheumatology

Model Details: 72 subjects will be randomized to two parallel groups (36 subjects per group) to receive simiaowan 6g twice daily or placebo. All subjects will be given febuxostat 40mg once daily as background therapy. Placebo will be administered to individuals randomized to that treatment group in a form identical to the simiaowan. The first investigational medicinal product dose will be administered the day after the randomization.

Study Record Dates

• First Submitted: August 23, 2019
• First Posted: August 28, 2019
• Study Start: September 1, 2019
• Primary Completion: July 28, 2020
• Study Completion: July 28, 2020
• Last Updated: August 30, 2019

Record last verified: 2019-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)