Gout
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: 1. Meet the American College of Rheumatology (ACR) classification criteria for Gout in 2015; 2. For male and female patients, the age of 18 = 50 mm (5 points); 5. NSAIDs and/or colchicine contraindications, intolerance, or lack of efficacy (according to the patient's medical history, referral records, etc., determined by the researcher); 6. Has no family planning and is willing to take reliable contraceptive measures during the study period and within 4 months after administration; 7. Can understand and comply with the test requirements, participate in the test voluntarily and sign written informed consent (ICF).
Exclusion criteria
Exclusion criteria: 1. Use any of the following drugs or therapeutic measures within a specified period before randomization: 1) Glucocorticoid drugs: Within 24 hours before the random any indications used dose of >= 10 mg or prednisone dragon or equivalent doses of the hormone; Long-term use of glucocorticoid therapy (defined as dragon dose prednisone or >= 5 mg/day or equivalent,> 28 days); Target within 14 days before the random intra-articular injections of glucocorticoid (a hormone steroid); At random within 14 days before any indications intramuscular injection of glucocorticoid; 2) Use of narcotic drugs (opioids or tramadol) in the 24 hours prior to randomization; 3) NSAIDs (including COX-2 inhibitors) and other analgesics: Ibuprofen: at random within 4 hours before use; Acetaminophen: at random within 4 hours before use; Pairs of chlorophenol acid: used in 8 hours before random; Naproxen: at random within 12 hours before use; Celecoxib: in the first 11 hours of random used; Beauty yesterday kang: 20 hours in front of the random used; Based on exam yesterday: used in random before 22 hours; Los SuoLuoFen sodium: 14 hours before random used; Other: the drug before random t1/2 used within any dose. 4) Colchicine was used within 12 hours before random; 2. If the patient is receiving uric acid lowering treatment, the drug must be taken at a stable dose for 2 weeks prior to randomization without changing the treatment regimen, and the treatment regimen must remain stable during the study period;However, if subjects are temporarily initiated uric acid lowering therapy due to this acute gouty arthritis, they may, at the discretion of the investigator, decide whether to discontinue this uric acid lowering therapy before receiving the experimental drug treatment, and may not initiate a new uric acid lowering regimen during the study period;If patients were not treated with uric acid lowering therapy before participating in the study, they may not start a new uric acid lowering regimen during the study period; 3. Patients with severe renal insufficiency (Scr >= 443 mol/L) or receiving hemodialysis treatment; 4. There is evidence or suspicion of infectious/septic arthritis, or other acute inflammatory arthritis; 5. Inadmissible for intramuscular injection (e.g., patients receiving anticoagulant therapy, thrombocytopenia, known hemorrhagic disease such as idiopathic thrombocytopenic purpura); 6. There are important diseases, including but not limited to: poorly controlled hypertension (>= 200/105 mmHg or higher), congestive heart failure (D), poor control of type I and type II (fasting glucose > 7.0 Mmol/L or random blood glucose > 11.1 mmol/ L) will be used to determine whether patients with these diseases can be included in this trial according to the opinion of the investigator; 7. According to the investigator's judgment, the patient's clinical condition is not suitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Vas score for joint pain; | — |
Countries
China
Contacts
Huashan Hospital, Fudan University