Clinical Drug Experience Knowledgebase

Criteria

Inclusion Criteria:

Subjects must present with confirmed diagnosis of gout, meeting the American College of Rheumatology (ACR) 1977 preliminary criteria for the classification of acute arthritis of primary gout
Subjects must have experienced at least one (1) acute gouty arthritic attack in the 12 months prior to randomization
Presence of acute gout flare for no longer than 3 days at Visit 2
Pain intensity at inclusion (Visit 2) of 7-10 on 11-point PI-NRS (defined as severe gout flare for this study)
All patients should not have contraindications for Colchicine use
Subjects with a history of intolerance to NSAIDs (Checklists Checklist 1)
Subjects with significant medical contraindication to NSAIDs (Checklist 2)
Subjects with past failure of NSAIDs to control acute gouty arthritis attacks in the previous 12 months (Checklist 3)

Regarding significant medical contraindication to NSAIDs or past failure of NSAIDs to control acute gouty arthritis attacks in the previous 12 months (i.e. refractoriness to NSAIDs) the patient must meet one of below criteria:

At least one historical episode within the previous 12 months of being refractory or intolerant to NSAIDs that makes the physician concerned to use NSAIDs for a subsequent acute gout attack
The current (referring) physician judgment is that NSAIDs are not appropriate for treating the patient's gouty arthritis flare which may be due to changes in patient status such as worsening co-morbid conditions or co-medications (e.g., GI tract disease, renal insufficiency, hypertension, fluid retention, concurrent use of diuretics and/or an angiotensin converting enzyme inhibitor or angiotensin receptor blocker, especially in CKD)
Subjects must be willing and able to give written informed consent. A HIPAA and/or state privacy consent must also be signed
Subjects must be able to swallow tablets
Use of permitted concomitant medications must be unchanged in dose and or frequency, 30 days prior to screening
Adequate organ function, evidenced by the following laboratory results within 90 days prior to randomization (historical lab results are acceptable).
Creatine clearance > 45 mL/min based on Cockroft-Gault glomerular filtration rate (GFR) estimation
For women of childbearing potential and men with partners of childbearing potential, agreement to use a highly effective, non-hormonal form of conception.

Exclusion Criteria:

Subjects with rheumatoid arthritis, psoriatic arthritis, evidence/suspicion of infectious/septic arthritis, acute polyarticular gout (4 or more joints), with arthritis due to any cause other than gout that may confound any study assessments per Investigator discretion
Subjects who have experienced >2 acute gouty arthritic attacks per month, or >12 attacks overall, in the 6 months prior to randomization
Subjects with a history of myocardial infarction, unstable angina, cerebrovascular events, or coronary artery bypass grafting within the previous 6 months prior to screening
Subjects with a Body Mass Index >45 kg/m2; calculated as body weight (kg)/height (m)2 at Screening Visit
Subjects with acute or chronic infections including known HIV and/or Hepatitis B or C
Uncontrolled hypertension (>160/90 mmHg seated) (if the first set of BP assessment meets the definition of uncontrolled hypertension, a second set of BP assessments may be performed after the patient has rested for at least 30 min. If the second set of BP assessments does not meet the definition of uncontrolled hypertension the patient will be eligible for participation)
Subjects with proteinuria ≥1+ or ≥30 mg on dipstick urinalysis that is confirmed on repeat assessment within 24 hours
Subjects with significant heart failure and activity impairment (Class III-IV of the New York Heart Association (NYHA)
Subjects with any history of malignancy, 5 years prior to randomization
Subjects with CKD NKF stages 3B -5 chronic renal dysfunction (eGFR <45 mL/min/1.73m2 acc. to Cockcroft Gault formula)
Subjects with serious hepatic disorder (Child-Pugh scores B or C)
Subjects who have not washed out of dopamine antagonists or depleting drugs excluding anticholinergics and/or antihistamines with anticholinergic effects at least 14 days prior to Day 1 (Visit 2)
Subjects with a documented history of alcohol or substance abuse within the 12 months prior to randomization(consumption of >21 units of alcohol per week is considered alcohol abuse)
Subjects with significant CNS effects including vertigo and dizziness