DeLand, FL (PRWEB) March 11, 2014
*To see if you qualify for this Osteoarthritis Clinical Trial in DeLand, visit Avail Clinical Research on the web (http://www.availclinical.com) or contact us directly at (386) 785-2404. There is no cost to participate, no insurance is required, and you may receive compensation for time and travel.
This is Phase 2, multicenter, double-blind, parallel-group, placebo-controlled study to evaluate the safety and efficacy of two different doses of new osteoarthritis ointment compared with a placebo ointment applied topically to 1 knee (target knee) for 4 weeks (day 1 through day 28) in patients with primary OA affecting a single knee. For each patient, duration of study participation will be approximately 12 weeks consisting of a 4-week screening period, a 4-week treatment period, and a 4-week follow-up period.
DURATION OF STUDY PARTICIPATION
This study will consist of an up to 4-week screening period (including a variable-length washout of prior OA therapy), a 4-week double-blind treatment period, and a 4-week follow-up period. Patients are expected to participate in this study for a maximum of approximately 14 weeks if all visit windows are extended to their maximum.
BACKGROUND & RATIONALE
Osteoarthritis (OA) is the most common form of arthritis, affecting over 20 million people in the United States (US). In persons 55 years or older, surveys in United Kingdom (UK) and worldwide reveal that 25% have experienced knee pain on most days per month over the prior year, and half of these individuals have radiographic OA sufficient to make the diagnosis of symptomatic OA of the knee. Radiologic findings of knee arthritis are age related, and are seen in up to one-third of the older adults. The diagnosis of OA should be based upon both clinical and radiographic criteria as 50% of those with radiographic changes of OA do not suffer pain, and 50% of people above age 55 years who complain of knee pain lack radiographic changes of OA. Osteoarthritis is more common in women than men, increases with age, and is a leading cause of impaired mobility in elderly people. The prevalence of painful disabling knee OA in people over age 55 years is 10%.
Risk factors include obesity, prior knee injury or surgery, and occupational factors such as bending and lifting. The pain experienced by patients with OA is typically related to activity and is believed to emanate from bone, synovial inflammation, or a stretched joint capsule. Common symptoms include pain on climbing stairs, arising from a chair, or walking long distances. Often patients complain of morning stiffness lasting for about 30 minutes. On examination, there may be tenderness at the junction of the femur and tibia, joint malalignment (varus or valgus deformity), and antalgic (limp due to avoidance of pain).
This experimental osteoarthritis treatment is a novel, potent, voltage-dependent, sodium channel (NaV) blocker being developed for the treatment of patients with various pain indications, including neuropathic and nociceptive pain. Although not previously studied in patients with OA, this topical ointment has been tested in clinical studies and was well tolerated by patients with postherpetic neuralgia (PHN) and erythromelalgia.
The primary objective of the study is to evaluate the efficacy of 4 weeks of topical administration of this experimental ointment compared with placebo for the relief of symptoms of primary OA of the target knee as assessed by the change from baseline (the 5 days prior to randomization [days –5 to –1]) to the last 5 days of treatment (days 24 to 28) in average evening pain intensity upon walking on a flat surface.
Male and female patients meeting all of the following criteria will be eligible to participate in this OA study: