Clinical trial: MPC-004 for the Treatment of an Acute Gout Flare (NCT00506883)

Eligibility criteria:
Inclusion Criteria:

          1. Patients of either gender and of any race ≥18 years of age.

          2. If female, patients must be postmenopausal as evidenced by lack of menses for ≥12
             consecutive months.

          3. Patients must present with a confirmed diagnosis of gout.

          4. Patients must have experienced ≥2 acute gouty arthritic attacks in the 12 months prior
             to randomization.

          5. Patients on urate lowering therapy must be on a stable dose and schedule with no
             changes in therapy for 4 weeks prior to randomization and expected to remain on a
             stable regimen during study participation.

          6. Patients must be willing to adhere to the study schedule and the protocol
             requirements.

          7. Patients must be willing and able to give written informed consent. A HIPAA and/or
             state privacy consent must also be signed.

        Exclusion Criteria:

          1. Patients with acute polyarticular gout (>4 joints).

          2. Patients who have experienced >2 acute gouty arthritic attacks per month, or >12
             attacks overall, in the 6 months prior to randomization.

          3. Patients with arthritis due to any cause other than gout that may confound any study
             assessments per Investigator discretion.

          4. Patients with a history of myocardial infarction, unstable angina, cerebrovascular
             events, or coronary artery bypass grafting within the previous 6 months prior to
             screening.

          5. Patients with active myeloid leukemia, obstructive gastrointestinal cancer, or
             metastatic cancer.

          6. Patients with chronic renal dysfunction (creatinine clearance <60 mL/min as estimated
             with the Cockcroft Gault formula).

          7. Patients with chronic hepatic dysfunction.

          8. Patients with a history of alcohol or substance abuse within the 12 months prior to
             randomization.

          9. Patients who have any concomitant illness or other finding that, in the opinion of the
             Investigator, would confound the study data or place the patient at unacceptable risk
             if the patient were to participate in the study, or that would require frequent
             adjustments in concomitant medications during the course of the study.

         10. Patients using systemic corticosteroid, cyclosporine, adalimumab, etanercept,
             infliximab, anakinra, abatacept, mycophenolate, azathioprine, anticoagulants
             (warfarin, heparin, low molecular weight heparin [LMWH], antithrombin agents, thrombin
             inhibitors, or selective Factor Xa inhibitors [note, use of aspirin ≤325 mg/day is
             allowed]), or chronic use of non steroidal anti inflammatory drugs (NSAIDs),
             acetaminophen, tramadol, and other analgesics such as opiates at screening

         11. Use of any investigational drug within 30 days prior to randomization.

         12. Patients currently participating in another research study or anticipated to enroll in
             such during participation in this study.

         13. Patients for whom informed consent cannot be obtained.

         14. Patients who have previously been randomized into this study and begun ingestion of
             study drug.
No condition on gender to be admitted to the trial.
Accepts Healthy Volunteers
Subject must be at least 18 Years old.


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? Contradiction