Birmingham, AL (PRWEB) April 15, 2014
*To see if you qualify for this Gout Clinical Trial in Birmingham, visit Achieve Clinical Research on the web (http://www.achieveclinical.com/) or contact us directly at (205) 380-6434. There is no cost to participate, no insurance is required, and you may receive compensation for time and travel.
This is a multi-center, randomized, double-blind, active and placebo-controlled study in gout patients with serum uric acid levels (sUA) greater than or equal to 7.5 mg/dL and less than or equal to 12 mg/dL who experienced at least three flares during the past 12 months and have not received treatment via any contemporary gout medications for at least two weeks prior to screening.
Because the occurrence of flares is the primary endpoint of this clinical study, qualified participants will not be allowed to take any medication for flare prophylaxis during the study period other than the supplied study drugs. Over the course of the treatment period (through Week 12), participants will receive one of two forms of the study medication as flare prophylaxis.
BACKGROUND & RATIONALE
This pharmaceutical company is pursuing the development of new form of gout medication for the prevention of flares and the chronic treatment of hyperuricemia in patients with gout. This new drug is an uricosuric agent with anti-inflammatory activity. It has two distinct mechanisms: first, it promotes excretion of uric acid by blocking its reabsorption by transporters/organic anion exchangers in the proximal tubule in the kidney; second, it exhibits anti-inflammatory activity by inhibiting monosodium urate (MSU) crystal induced NF-KB-dependent production of interleukin 1-beta (IL-1β), a predominant cytokine mediator in acute gouty arthritis. Thus, this experimental gout medication has the potential to reduce serum uric acid while decreasing the incidence, severity and duration of flares, including those that often occur upon initiation of urate lowering therapy (ULT).
This pharmaceutical company previously pursued development of this experimental drug as an oral glucose-lowering agent (insulin-sensitizer) for the treatment of type 2 diabetes. However, the target efficacy for hemoglobin A1c (HbA1c) lowering compared to the marketed insulin-sensitizers was not met, and further development for type 2 diabetes has been discontinued.
The primary objective of this clinical trial is to evaluate the efficacy of two dose levels of this experimental gout medication taken once daily for the prevention of flares in adult gout patients.
Patients must meet all of the following criteria to be eligible for study participation:
*Achieve Clinical Research conducts Phase II-IV Clinical Research Studies in Alabama. For more information about participating in a Gout Clinical Study, please visit our website or contact us directly at (205) 380-6434.