Status:
COMPLETED
Lidoderm® (Lidocaine Patch 5%) in Diabetic and Idiopathic Neuropathy
Lead Sponsor:
Endo Pharmaceuticals
Conditions:
Diabetes
Eligibility:
All Genders
18-90 years
Phase:
PHASE4
Brief Summary
Patients with Type I or II diabetes and painful distal symmetric sensorimotor polyneuropathy with dynamic allodynia of the lower extremities, patients with Type I or II diabetes and pain distal symmet...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
Estimated Enrollment :
76 Patients enrolled
Trial Details
Trial ID
NCT00903851
Start Date
April 1 2002
Last Update
February 15 2010
Active Locations (4)
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1
Birmingham, Alabama, United States
2
Hueytown, Alabama, United States
3
Jacksonville, Florida, United States
4
Rochester, New York, United States