The Analgesic Activity of a Topical Formulation in Patients With Osteoarthritis of the Hands
Status:
Unknown status
Trial end date:
2016-03-01
Target enrollment:
Participant gender:
Summary
Osteoarthritis (OA) affects over 30 million people in the United States and represents our
nation's leading cause of disability. Data for the years between 1996-2005, indicate that OA
raised overall health care costs by $185.5 billion annually. Largely as a consequence of this
disease, the number of patients undergoing joint replacement surgery will quadruple over the
next 17 years. Importantly, several recent studies have demonstrated that OA is an
independent risk factor for cardiovascular disease . Presently investigators have no
medications that alter the natural history of OA. Weight control, exercise and some physical
therapy measures are the only interventions short of total joint replacement that alter the
course of this disease. To make matters worse, investigators have experienced only setbacks
in use of medications aimed at symptom control. Recognition of toxicities of non-steroidal
anti-inflammatory drugs (NSAIDs) and narcotic-based analgesics has narrowed the presently
available armamentarium for pain control in OA . Clearly OA is a major factor that demands
better solutions as the health care system is redesigned.
OA involving the hands represents a major part of the overall burden of this disease. In
radiographic surveys about a quarter of the total US population has changes consistent with
OA involving the hands. Among the elderly, radiographic hand OA has been found in over half
of such individuals and as many as a quarter of them suffer from pain and functional
incapacitation. The joints affected typically are the first carpometacarpal (CMC-1) joint,
the distal interphalangeal (DIP) joints, and the proximal interphalangeal (PIP) joints .
Therapeutic options include acetaminophen, nonsteroidal anti-inflammatory drugs (NSAIDs), and
a variety of physical measures such as physical therapy, bracing, and heat and cold
applications. To achieve some symptomatic benefit while limiting systemic toxicity, topical
therapies have been developed which either act as counter irritants, seek to reduce substance
P (capsaicin), or to deliver an NSAID locally through the skin. The leading example of the
latter is Diclofenac sodium gel which was shown to reduce pain intensity and improve hand
function in a double blind controlled trial. However none of these measures have proven
sufficiently effective to meet patient needs. Topical polytherapy will be employed in this
study to see if it will be effective against the pain of OA.
Phase:
Early Phase 1
Details
Lead Sponsor:
Transdermal Therapeutics, Inc.
Collaborators:
Albert Einstein College of Medicine Albert Einstein College of Medicine of Yeshiva University Montefiore Medical Center