The Analgesic Activity of a Topical Formulation in Patients With Osteoarthritis of the Hands

Launched by TRANSDERMAL THERAPEUTICS, INC. · Jun 25, 2015

Keywords

ClinConnect Summary

A potentially more effective approach is to provide a combination of analgesic and anti-inflammatory agents through a topical delivery system. In the present study compounds with anti-inflammatory and analgesic properties will be combined in a vehicle that promotes penetration of molecules through the skin to deeper underlying tissues such as the joint capsule at articulations in the hands. The vehicle consists of Versapro cream base (a formulation of Medisca, Inc. that contains Vitamin E and Aloe Vera, along with other ingredients that are proprietary), Tranilast powder, Pentoxifylline USP...

Gender

ALL

Eligibility 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.