Gout FlareNCT04069325
Efficacy and Safety of Simiaowan in Prevention of Acute Flares in Chronic Gout Patients Initiating Febuxostat Therapy
A study testing simiaowan and febuxostat in people with Gout Flare, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Gout Flare
- What is being tested?
- simiaowan and febuxostat
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 72 participants
- Where
- 1 siteChina
- Study dates
- 1 Sep 2019to 28 Jul 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 18Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
China1 site
Guang'anmen Hospital
Beijing, Beijing Municipality, 100053
Quan Jiang, Doctor, 86-010-88001132, doctorjq@126.com
About this study
Official title: 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.
Read the 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.
- Conditions
- Gout Flare
- Being tested
- simiaowan, placebo, febuxostat
- Keywords
- gout, acute flares, prevention, febuxostat
- Medical subject headings
- Gout
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
simiaowanDrug
pills, 6g twice daily (BID), oral, 12 weeks
placeboDrug
pills, 6g twice daily (BID), oral, 12 weeks
febuxostatDrug
tablets, 40 mg once daily (QD), oral, 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| simiaowan 6g + febuxostat 40mg | Experimental | Not described Receives: Drug: simiaowan; Drug: febuxostat |
| placebo 6g + febuxostat 40mg | Placebo comparator | Not described Receives: Drug: placebo; Drug: febuxostat |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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
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.
Measured: Day 1 to Week 12
Proportion of subjects in each group achieving serum uric acid concentration≤ 7 mg/dL (420μmol/L)
Measured: Week4, Week 8 and Week 12
Proportion of subjects experiencing from ≥ 1 gout flare and ≥ 2 gout flares within 12 weeks
Measured: 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).
Measured: 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).
Measured: Day 1 to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2019
- Study start1 Sep 2019 (estimated)
- Primary completion28 Jul 2020 (estimated)
- Study completion28 Jul 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gout FlareStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Sponsor type
- University, hospital or other
- Collaborators
- Affiliated Hospital of Nanjing University of Chinese Medicine, The Second Affiliated Hospital of Dalian Medical University
- Responsible party
- Principal investigator, Quan Jiang, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
- Investigators
- Jiang Quan, Doctor, Principal investigator, Guang'anmen Hospital of China Academy of Chinese Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04069325
- Sponsor's protocol ID
- WD-18-F02
- Status last verified
- Aug 2019
- First submitted
- 23 Aug 2019
- Last updated
- 30 Aug 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Simiaowan in Prevention of Acute Flares in Chronic Gout Patients Initiating Febuxostat Therapy：a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04069325
- Acronym / sponsor ID
- WD-18-F02
- Conditions
- Gout Flare
- Keywords
- gout, acute flares, prevention, febuxostat
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- Guang'anmen Hospital of China Academy of Chinese Medical SciencesUniversity, hospital or other
- Collaborators
- Affiliated Hospital of Nanjing University of Chinese Medicine, The Second Affiliated Hospital of Dalian Medical University
- Study start
- 1 Sep 2019 (estimated)
- Primary completion
- 28 Jul 2020 (estimated)
- Study completion
- 28 Jul 2020 (estimated)
- First posted
- 28 Aug 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| simiaowan 6g + febuxostat 40mg | Experimental | Drug: simiaowan, Drug: febuxostat |
| placebo 6g + febuxostat 40mg | Placebo comparator | Drug: placebo, Drug: febuxostat |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (18 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| simiaowanpills, 6g twice daily (BID), oral, 12 weeks | Drug | simiaowan 6g + febuxostat 40mg |
| placebopills, 6g twice daily (BID), oral, 12 weeks | Drug | placebo 6g + febuxostat 40mg |
| febuxostattablets, 40 mg once daily (QD), oral, 12 weeks | Drug | placebo 6g + febuxostat 40mg, simiaowan 6g + febuxostat 40mg |
Primary outcome
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.
5 secondary outcomes
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
Proportion of subjects in each group achieving serum uric acid concentration≤ 7 mg/dL (420μmol/L)
Time frame: 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
Mean pain Visual Analogue Scale Score (VAS) associated with gout flares
Time frame: Day 1 to Week 12
Amount of rescue medication taken within 12 weeks
Time frame: Day 1 to Week 12
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Gout Flare
Not yet recruitingPhase 2
A Study of Efficacy and Safety of IBI3011 in Subjects With Acute Gouty Arthritis
Acute Gouty Arthritis
RecruitingPhase 2
A Study to Evaluate the Efficacy,Safety,Tolerability,Pharmacokinetics,and Immunogenicty of Plonmarlimab in Subjects With Acute Gouty Arthritis
Acute Gouty Arthritis
Not yet recruitingPhase 4
Mazdutide for Weight Management and Gout in Adults With Obesity
Gout, Obesity (BMI>30)
RecruitingPhase 2
Clinical Study of HRS-2129 for Acute Gouty Arthritis
Acute Gouty Arthritis
Not yet recruitingPhase 2
A Study of SSGJ-613 in Gout Participants Initiating Urate-Lowering Treatment
Gout Arthritis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jiang Quan, Doctor principal investigator
Guang'anmen Hospital of China Academy of Chinese Medical Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing simiaowan and febuxostat in people with Gout Flare, run by Guang'anmen Hospital of China Academy of Chinese Medical Sciences at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jiang Quan, Doctor (86-010-88001132, doctorjq@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of subjects experiencing ≥ 1 gout flare within 12 weeks (time frame: Day 1 to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2019.