“CAPSS,” A Randomized, Double-Blind, Placebo-Controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Tramadol HCl /Acetaminophen for the Treatment of Painful Diabetic Neuropathy   Sponsor     Ortho-McNeil Pharmaceutical Inc.   Berman Center Investigator     Site Principal Investigator: William David, MD, PhD   Berman Center Site Coordinator     Shirley Conn, RN 612-341-7907   Description     The objective of this study is to compare the analgesic efficacy and safety of tramadol HCl and acetaminophen versus placebo for the treatment of painful diabetic neuropathy.   Role of the Berman Center     The Berman Center will enroll 9 participants for this study. It will conduct all medical examinations and collection of study data required by the protocol (6-7 visits over four months). A medical neurologist is the Berman Center Site Principal Investigator.   Abstract     Since August 15, 2001, the tablet combination of tramadol hydrochloride with acetaminophen (tramadol HCI/acetaminophen) has been approved in the United States for the short-term (less than five days) management of acute pain. However, it holds the status of an investigational drug for long-term pain management. Persons with type I or type II diabetes often experience painful conditions in the extremities due to diabetic neuropathy. While tricyclic antidepressants (TCAs) have been used as a first-line treatment for diabetic neuropathic pain for some time, TCAs are limited by significant side effects, including orthostatic hypotension, sedation, dry mouth, weight gain, and sexual dysfunction. Further, successful treatment of neuropathic pain often requires more than one agent, working through different mechanisms of action, to provide optimum analgesia. There is significant reason to believe that the multiple mechanisms of action of tramadol HCI/acetaminophen may make it an effective choice for neuropathic pain. The objective of this study is to compare the analgesic efficacy and safety of tramadol HCl and acetaminophen versus placebo for the treatment of painful diabetic neuropathy. Approximately 300 subjects experiencing painful diabetic neuropathy will be enrolled at multiple sites. The study design is a randomized, double-blinded, parallel group, placebo-controlled, clinical trial.