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

August 28, 2019 updated by: Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences

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

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
72

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.
  • 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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Proportion of subjects experiencing ≥ 1 gout flare within 12 weeks
Time Frame: Day 1 to Week 12
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
The incidence of new gout flares within 12 weeks in the simiaowan group compared to the placebo group
Time Frame: Day 1 to Week 12
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)
Time Frame: Week4, Week 8 and Week 12
Week4, Week 8 and Week 12
Proportion of subjects experiencing from ≥ 1 gout flare and ≥ 2 gout flares within 12 weeks
Time Frame: Day 1 to Week 12
Day 1 to Week 12
Mean pain Visual Analogue Scale Score (VAS) associated with gout flares
Time Frame: Day 1 to Week 12
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
Time Frame: Day 1 to Week 12
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

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Guang'anmen Hospital of China Academy of Chinese Medical Sciences

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
The Second Affiliated Hospital of Dalian Medical University
Shenzhen Traditional Chinese Medicine Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 1, 2019

Primary Completion (ANTICIPATED)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 28, 2020

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 28, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 23, 2019

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 23, 2019

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 28, 2019

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 30, 2019

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2019

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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