Evaluation of the Safety and Efficacy of PENNSAID Gel in the Treatment of Osteoarthritis of the Knee
Osteoarthritis (OA) is the most common form of arthritis and can cause pain, swelling, and
reduced motion in the joints, which as a result can impact quality of life. It can occur in
any joint, but usually affects the hands, knees, hips or spine. The purpose of this study is
to determine the efficacy and safety of a topical nonsteroidal anti-inflammatory drug
(NSAID) gel formulation in the treatment of osteoarthritis of the knee.
Pharmacokinetics, Bioavailability and Safety of PENNSAID® Gel
It is anticipated that PENNSAID Gel will minimize systemic exposure versus oral diclofenac
administered twice a day (BID). In addition, PENNSAID Gel should result in greater subject
convenience and compliance with a comparable bioavailability, safety and tolerability
profile to that of the approved PENNSAID solution administered four times a day (QID).
Efficacy of PENNSAID® for Pain Management in the Emergency Department
Medtronic - MITG
The primary objective of this study is to compare the pain relieving effect and speed of
onset of PENNSAID to that of standard oral diclofenac under double blind conditions using a
growth curve approach to pain measurement. The investigators will test the hypothesis that
PENNSAID will provide more rapid pain relief than oral diclofenac during the ED visit. The
secondary goal of the proposed work is to discover and model the onset and course of pain
relief during the emergency department (ED) visit.
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