Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Endo USA Inc., a Keenova Therapeutics Company
Age
18–90
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
At Sites 1, 2, and 3 - Had painful diabetic polyneuropathy of 3 or more months duration
At Site 1 only - Had clinical signs and symptoms of distal predominantly sensory polyneuropathy of 3 or more months duration. Diagnosis of predominantly sensory polyneuropathy were to be confirmed by either nerve conduction studies (large fiber sensory or sensorimotor axonal neuropathy) or by abnormal epidermal innervations on punch skin biopsy (distal leg/proximal thigh) (Herrmann et al., 1999; Holland et al., 1997)
Had an average daily pain rating for the baseline week of pain ratings equal to 4 or greater on the 0 to 10 numerical pain rating scale
Had at least 2 hours of moderate or severe pain intensity due to polyneuropathy daily in the immediately prior 3-month period
Were using stable analgesic drug therapy for at least 1 week (regimen and dosages) prior to screening visit, with the exception of acetaminophen and lidocaine for patients undergoing a punch skin biopsy
You may not be if
Had prior treatment with topical lidocaine, except for use with the punch skin biopsy procedure
Were currently under treatment with Class I antiarrhythmic agents (such as tocainide and mexiletine)
Had any other pain more severe than the painful diabetic or idiopathic neuropathy
Had open skin lesions in the area where the lidocaine patches were to be applied
