DeLand, FL (PRWEB) July 15, 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 a Phase 2, multicenter, double-blind (within dose), placebo-controlled, proof-of-concept and dose-range-finding study to evaluate the efficacy, safety, and pharmacokinetics of an experimental spray in adult subjects with clinically symptomatic mild to moderate OA of the knee. For subjects with bilateral knee pain, both knees will be treated, but the most symptomatic knee (i.e., the most painful knee as measured by the Western Ontario and McMaster University Osteoarthritis Index pain subscale score at the time of screening) will be designated as the target knee for efficacy analyses. For subjects with unilateral knee pain, only the symptomatic (target) knee will be treated.
DURATION OF STUDY PARTICIPATION
Each subject will receive study treatment for 12 weeks starting on Day 1. Qualified site personnel will contact subjects 1 week after the first administration of study medication to check if there are any issues with the spray bottles, administration of study medication, or adverse events (AEs). Subjects will return to the site at 2, 4, 8 and 12 weeks of treatment for efficacy and safety assessments. The Week 12 visit will be the end of study (EOS) visit. On the final day of dose administration (the Week 12/EOS) visit, subjects will receive 1 dose of study medication in the morning only, and radiographs will be performed to assess changes in the target knee joint space. Subjects will have a Follow-up visit approximately 7 days after the Week 12/EOS visit.
BACKGROUND & RATIONALE
Osteoarthritis (OA) of the hip or knee is a major cause of medical disability and costs in the US. The prevalence of symptomatic OA has been assessed at 12% in the US population of persons ages 25 to 75 years. Direct and indirect costs for OA of the knee and hip in the US in 1994 were $15.5 billion and account for a substantial proportion of costs in managed care plans. There are steps people can take to prevent this disease.
This experimental spray is a new prodrug of ibuprofen that is being developed as a topical NSAID spray for the relief of acute pain and the signs and symptoms of OA. In vitro studies demonstrated that the spray, when administered topically to rat skin, can penetrate rat skin at a very high rate and has up to 75% bioavailability in rats. Studies in rats and other animal species showed that the topically administered spray was readily converted to ibuprofen in plasma and other tissues. When the spray is converted to ibuprofen in vivo, 2-(diethylamino) ethanol, an inactive precursor chemical for many currently marketed drugs is released. The half-life of the experimental spray in rat plasma is about 1 minute, and more than 99% of the dose is converted to ibuprofen in 20 minutes in rat plasma (at 37°C). The half-life in human plasma is about 5.83 minutes, and 98.5% of the dose is converted to ibuprofen in 20 minutes in human plasma (at 37°C).
The primary objective of this study is to evaluate the efficacy of an experimental spray compared to a placebo for relief of knee pain in subjects with OA of the knee.
To be eligible to participate in the study, subjects must meet the following criteria:
- A subject must be a male or female between 35 and 85 years of age, inclusive;
- A subject must have a body mass index (BMI) between 18.5 and 39.9 kg/m2, inclusive;
- A subject must have a diagnosis of idiopathic OA according to the American College of Rheumatology (ACR) clinical and radiographic criteria;
- A subject must have a Kellgren-Lawrence Grade of 1 or 2 as determined by the Investigator or a local radiologist at Screening.
- A subject must have a history of clinically symptomatic mild to moderate OA of the knee for 6 months or more;
- A subject must have had knee pain while standing, walking, and/or on motion for at least 14 days during the month prior to Screening;
- A subject must have a knee pain score of at least 40 mm and less than 90 mm on a 100-mm VAS (with or without analgesic medication) on at least 10 of the 14 days prior to randomization;
- A subject must be willing to discontinue any NSAIDs or other analgesic (eg, aspirin, acetaminophen) or potentially confounding concomitant treatments (eg, physiotherapy, acupuncture) starting 4 days before the administration of the first dose of study medication until completing participation in the study. (The use of at least 325 mg/day of acetylsalicylic acid as cardiac prophylaxis is permitted.) The subject will be allowed to take a rescue medication (acetaminophen) for pain during the study except during the 24 hours prior to Baseline (Day 1), Week 2, Week 4, Week 8, Week 12/EOS, and Follow-up assessments;
- A subject must be willing to avoid unaccustomed physical activity (eg, starting a new weight lifting routine) for the duration of the study;
- With the exception of OA of the knee, the subject must be in good general health with no clinically significant findings from medical history, vital signs, physical examination, ECG, and routine laboratory tests that could interfere with subject safety or pain and functional assessments as determined by the Investigator;
- A subject must have negative tests for selected drugs of abuse at Screening;
- A subject must have a negative hepatitis panel (including hepatitis B surface antigen [HbsAg] and antibodies against the hepatitis C virus [anti-HCV]) and a negative human immunodeficiency virus (HIV) antibody screen;
- Female subjects must be postmenopausal, be surgically sterile for at least 90 days, or agree to use one of the following forms of contraception from the time of signing the informed consent until 30 days after study completion: a non-hormonal intrauterine device (IUD) with spermicide, female condom with spermicide, contraceptive sponge with spermicide, diaphragm with spermicide, cervical cap with spermicide, a male sexual partner who agrees to use a male condom with spermicide, or a sterile sexual partner.
- Male subjects must either be sterile or agree to use one of the following approved methods of contraception from administration of study drug on Day 1 until 45 days following study completion: a male condom with spermicide; a sterile sexual partner; use by female sexual partner of an IUD with spermicide, a female condom with spermicide, contraceptive sponge with spermicide, a diaphragm with spermicide, a cervical cap with spermicide, or oral, implantable, transdermal, or injectable contraceptives.
- A subject must be able to comprehend and willing to sign an ICF.
- Avail Clinical Research conducts a variety of Clinical Research Studies in Florida. For more information about participating in an Osteoarthritis Clinical Trial, please visit our website or contact us directly at (386) 785-2404.