Diabetes
Conditions
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 symmetric sensorimotor polyneuropathy with no dynamic allodynia of the lower extremities, or patients with idiopathic distal predominantly sensory neuropathy participated in a Phase IV clinical trial to assess the efficacy of lidocaine patches in treating painful diabetic neuropathy or idiopathic distal sensory neuropathy.
Interventions
DRUGLidoderm
Patients participated in an 8-week treatment period; patients at one site were to continue treatment for the entire 8 weeks while patients at two sites were to terminate treatment after 3 weeks. Commercially available Lidoderm® (lidocaine patch 5%) was provided to each patient with up to four patches applied topically 18 hours on, 6 hours off per day to the area of maximal peripheral neuropathic pain.
Sponsors
Endo Pharmaceuticals
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean change from baseline to Week 3 in average pain intensity as measured from patient diaries using Brief Pain Inventory Question 5. | Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56) |
Secondary
| Measure | Time frame |
|---|---|
| Other Pain Questions in BPI | Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56) |
| Weekly pain intensity/relief measures | Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56) |
| Pain duration using questions that assess duration and frequency of pain | Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56) |
| McGill Pain Questionnaire | Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56) |
| Neuropathy Pain Scale | Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56) |
| Assessment of safety was based on AEs, skin assessment, physical examination, vital signs, clinical laboratory data, and plasma lidocaine levels | Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56) |
| Assessment of allodynia | Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56) |
Countries
United States
Outcome results
None listed