Clinical trial: Prospective Analgesic Compound Efficacy (PACE) Study (NCT02403687)

Eligibility criteria:
Inclusion Criteria:

          -  4.1.1 Primary complaint or clinical findings of arthritis, tendonitis, gout,
             synovitis, radiculopathy, muscle spasms, migraines, and/or idiopathic pain.

        4.1.2 No new pain medications of any kind in the last 4 weeks. 4.1.3 Between the ages of
        18-85yrs.

        Exclusion Criteria:

          -  4.2.1 Current or history of disease or disorders of the liver, kidneys,
             gastrointestinal system, or cardiovascular system.

        4.2.2 Blood test indicating kidney, liver, or cardiovascular function outside of normal
        clinically accepted ranges. Blood test must be performed in the last 7 days.

        4.2.3 Broken or inflamed skin, burns, open wounds, atopic dermatitis or eczema in the area
        of pain where the compound cream and transdermal patch would be applied.

        4.2.4 Women who are pregnant, nursing, or planning to become pregnant in the next 52-weeks.

        4.2.5 Allergy/sensitivity to study drugs or their formulations. 4.2.6 Active drug or
        alcohol use or dependence that, in the opinion of the site investigator, would interfere
        with adherence to study requirements.

        4.2.7 Serious illness (requiring systemic treatment and/or hospitalization) until subject
        either completes therapy or is clinically stable on therapy, in the opinion of the site
        investigator, for at least 14 days prior to study entry.

        4.2.8 Inability or unwillingness of subject to give written informed consent.
No condition on gender to be admitted to the trial.
No healthy subjects accepted to join the trial.
Subject must be at least 18 Years old.
Subject must be at most 85 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