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: 0
• Participant gender: All

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
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Transdermal Therapeutics, Inc.
• Collaborators: Albert Einstein College of Medicine; Albert Einstein College of Medicine of Yeshiva University; Montefiore Medical Center
• Treatments: Analgesics; Baclofen; Bupivacaine; Diclofenac; Orphenadrine

Criteria

Inclusion Criteria:

• OA in at least one hand as defined by ACR Criteria (nodal enlargement in two or more of 10 defined joints, CMC-1, MCP=1, PIPs and DIPs).

• Hand pain duration greater than one year.

• History of NSAID use for hand pain on at least one occasion during the last year.

• Age 40 to 79 years.

• Ability to understand the English language and to comprehend written material at the 5th grade level.

Exclusion Criteria:

• History of psoriasis

• Other painful rheumatic disease, measured by a blood draw that will test for RF factor and ESR.

• Rheumatoid arthritis, as measured by hand x-rays.

• Any diagnosis of fibromyalgia or neurovascular disease.

• Presence of Raynaud's disease.

• -Presence of Raynaud's disease.

• Presence of any peripheral neuropathy.

• Presence of cervical radiculopathy.

• Pregnancy in females (pregnancy test will be administered at intake to females of reproductive capability and their method of birth control recorded.)

• Persons under age 40. Insufficient data are available in adults to judge potential risk in children.

• Those who are not capable of providing informed consent.

• Known allergy to analgesic drugs and the drugs used in this study.

• Those who do not comprehend English. As this is a short-term Pilot study, the potential benefits to the participants is currently unknown. Based upon this knowledge, we believe we are exempt from the requirement to translate the informed consent form into Spanish.

• Those with renal and/or gastrointestinal impairments, i.e. with a creatinine level of 2 and GFS level 4.