Clinical trial: Study of of URC102 to Assess the Efficacy and Safety in Gout Patients (NCT04804111)

Eligibility criteria:
Inclusion Criteria:

          -  Screening Inclusion Criteria The subjects must meet all the following criteria to be
             eligible for articipation in this study.

               1. Subjects who are aged ≥19 and <70 years at the time of providing written informed
                  consent

               2. Subjects who are diagnosed with gout according to American College of
                  Rheumatology (1977) criteria for the classification of acute arthritis of primary
                  gout.

               3. Subjects who have the ability and willingness to actively conduct TLC recommended
                  in this study

               4. Subjects who provided written informed consent to voluntarily participate in the
                  study

          -  Randomization Inclusion Criterion. Subjects who meet the screening inclusion criteria
             will be randomly assigned to the following criteria.

               1. sUA ≥ 7.0 mg/dL at Visit 2

                  Exclusion Criteria:

               1. Subjects who have medical history or comorbidity as follow; (1) Active malignancy
                  or history of malignancy within the past 5 years at the time of screening (2)
                  Urolithiasis (3) Clinically important allergic disease (anaphylactic shock, etc.)
                  (4) Lesch-Nyhan syndrome (5) Hereditary problems such as galactose intolerance,
                  Lapp lactase deficiency or glucose-galactose malabsorption (6) Ischemic heart
                  diseases or congestive heart failure (7) Organ transplantation (recipient or
                  scheduled to receipt)

               2. Subjects who have comorbidity or abnormality of lab results as follows; (1)
                  Uncontrolled diabetes mellitus with drug therapy

                    -  HbA1c ≥ 9% or

                    -  Fasting plasma glucose (FPG) ≥160 mg/dL (2) Uncontrolled hypertension with
                       treatment

                    -  Systolic blood pressure (SBP) ≥180 mmHg or

                    -  Diastolic blood pressure (DBP) ≥ 110 mmHg (3) Uncontrolled dyslipidemia with
                       treatment

                    -  Total cholesterol ≥ 250 mg/dL (at least 8 hours of fasting) (4) Aspartate
                       aminotransferase (AST) or alanine aminotransferase (ALT) ≥ 2 X upper limit
                       of normal (ULN) or Total bilirubin ≥ 1.5 X ULN (5) eGFR* < 60 mL/min/1.73m2
                       * eGFR (MDRD equation) GFR(ml/min/1.73m2) = 186 × (SCr)-1.154 × (age)-0.203
                       × (0.742 if female) × (1.210 if African American) (6) Uncontrolled thyroid
                       function with treatment (thyroid-stimulating hormone (TSH) ≥ 1.5 X UNL

               3. Subjects who are judged by the investigator to have a clinical cardiovascular
                  disease that may affect the study based on the 12-lead ECG obtained at screening
                  or those suspected to be at such risk

               4. Patients who have received or plan to receive any XOI or uricosuric agents within
                  3 weeks prior to study treatment

               5. Patients who have received or plan to receive diuretics or any medication action
                  on human Uric Acid Transporter 1(hURAT1) such as indomethacin, pyrazinamide,
                  fenofibrate, atorvastatin, amlodipine, losartan, captopril, enalapril,
                  salicylates etc. within 2 weeks prior to study treatment However, those who have
                  been on stable doses as below are allowed to participate in the study, if the
                  administration method and dosage remain the same during the study period (1)
                  Diuretics (thiazide only or thiazide-based combination, etc.) and
                  antihypertensive agents (losartan etc.) used for the treatment of hypertension
                  (2) Fenofibrate or lipid lowering drugs (atorvastatin) used for hyperlipidemia
                  (3) Salicylates (aspirin)

               6. Patients who have been administered or plan to administer Mercaptopurine,
                  Azathioprine, Theophyline within 1 week or within more than 5 times of its
                  half-life prior to the Visit 1

               7. HIV Ag/Ab, HBs Ag or HCV Ab positive at screening

               8. Subjects who have known hypersensitivity or allergy to IPs (URC102 or febuxostat)
                  or any components in their formulations

               9. Subjects who have childbearing or nursing

              10. Subjects who agree to use methods of birth control* during the study period and
                  for up to 7 days after the final administration of the IP

                  * Methods of birth control: ① intrauterine device or birth control implant, ②
                  dual protection (condom with spermicide and contraceptive diaphragm or
                  contraceptive sponge or cervical cap ③ surgical sterilization (vasectomy or tubal
                  ligation or etc.)

              11. Subjects who have been administered any other IP or investigational device by
                  participating in other studieswithin 4 weeks or within more than 5 times of its
                  halflife prior to the Visit 1

              12. Subjects who have a history of drug or alcohol abuse within 5 years prior to the
                  Visit 1

              13. Subjects who have any other reason that may affect the study or those who are
                  judged by the investigator to be ineligible for participation in the study
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 19 Years old.
Subject must be at most 69 Years

Patient description (medical language): A 39-year-old man comes to the emergency department with an acute onset of severe left toe pain.  The toe is red and exhibits swelling. The patient is not febrile, and does not remember any recent trauma. Medical history is not significant except for the similar attacks and the diagnosis of gouty arthritis. His medication history includes Allopurinol to prevent gouty attacks. His father has the same medical condition. However, his older brother who is 41 years old is healthy with no history of gouty arthritis. Physical examination shows a swollen, tender first metatarsophalangeal joint.  Aspiration of the joint showed high leukocyte count, negative Gram stain, and numerous needle-shaped crystals, which is compatible with gouty arthritis.

Patient description (patient's own words): I'm a 39-year-old man and got admitted to the ER after an unbearable pain in my left toe. My toe was red and terribly swollen. I was still standing on my feet, not febrile and I don't remember hitting my head or anything. I don't have any special medical history, but I had been diagnosed with gout before. I take Lopurin to prevent my gouty attacks. My dad had the same problem, but my 41-year-old brother is healthy and does not have gouty attacks. The doctor did a physical exam and found that the joints between my toes and the rest of my foot were swollen and tender. The doctor renewed his diagnosis of gouty arthritis.

Does the patient match the trial criteria? Entailment