MPC-004 for the Treatment of an Acute Gout Flare
Condition: Gout
MeSH terms: Gout
Intervention: High Dose Colchicine (4.8 mg total dose); Low Dose Colchicine (1.8mg total dose); Placebo Control
Intervention description: At randomization, patients were given an identical looking blister pack containing (8) over encapsulated colchicine 0.6 mg tablets identical in appearance to placebo capsules. Patients were instructed to take 2 capsules initially (1.2 mg) followed by an additional capsule (0.6 mg) every hour for a total of six additional doses (total colchicine dose 4.8 mg) beginning within 12 hours of onset of a qualifying gout flare as confirmed by calling the gout flare call center.; At randomization, patients were given an identical looking blister pack containing (3) over encapsulated colchicine 0.6 mg tablets identical in appearance to placebo capsules and five placebo capsules. Patients were instructed to take 2 capsules initially (0.6 mg x 2) followed by an additional capsule every hour for a total of six additional doses (one active (0.6 mg) and 5 placebo capsules), a total colchicine dose = 1.8 mg) beginning within 12 hours of onset of a qualifying gout flare as confirmed by calling the gout flare call center; At randomization, patients were given an identical looking blister pack containing (8) placebo capsules identical in appearance to the study drug. Patients were instructed to take 2 capsules initially followed by an additional capsule every hour for a total of six additional doses beginning within 12 hours of onset of a qualifying gout flare as confirmed by calling the gout flare call center.
Intervention MeSH terms: Colchicine
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Double (Participant, Investigator)
Enrollment: 185.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: Accepts Healthy Volunteers

Summary:

      This study is a multicenter, randomized, double-blind, placebo-controlled, parallel group,
      dose-comparison to determine the efficacy and safety of a standard-dose of colchicine (4.8
      mg) versus low-dose colchicine (1.8 mg) or placebo for acute gout flares.
    

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.