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

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

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.

Study Overview

• Status: Unknown
• Conditions: Gout Flare
• Intervention / Treatment: Drug: simiaowan; Drug: febuxostat; Drug: placebo

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 72
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jiang Quan, Doctor; Phone Number: 86-010-88001132; Email: doctorjq@126.com

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100053
      • Guang'anmen hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: TRIPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: simiaowan 6g + febuxostat 40mg	Drug: simiaowan; pills, 6g twice daily (BID), oral, 12 weeks; Drug: febuxostat; tablets, 40 mg once daily (QD), oral, 12 weeks
PLACEBO_COMPARATOR: placebo 6g + febuxostat 40mg	Drug: febuxostat; tablets, 40 mg once daily (QD), oral, 12 weeks; Drug: placebo; pills, 6g twice daily (BID), oral, 12 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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	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
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

Collaborators and Investigators

• Sponsor: Guang'anmen Hospital of China Academy of Chinese Medical Sciences
• Collaborators: The Second Affiliated Hospital of Dalian Medical University; Shenzhen Traditional Chinese Medicine Hospital

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2019
• Primary Completion (ANTICIPATED): July 28, 2020
• Study Completion (ANTICIPATED): July 28, 2020

Study Registration Dates

• First Submitted: August 23, 2019
• First Submitted That Met QC Criteria: August 23, 2019
• First Posted (ACTUAL): August 28, 2019

Study Record Updates

• Last Update Posted (ACTUAL): August 30, 2019
• Last Update Submitted That Met QC Criteria: August 28, 2019
• Last Verified: August 1, 2019

More Information

Terms related to this study

• Keywords: prevention; gout; febuxostat; acute flares
• Additional Relevant MeSH Terms: Metabolic Diseases; Genetic Diseases, Inborn; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Arthritis; Metabolism, Inborn Errors; Crystal Arthropathies; Purine-Pyrimidine Metabolism, Inborn Errors; Gout; Antirheumatic Agents; Gout Suppressants; Febuxostat
• Other Study ID Numbers: WD-18-F02

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No