Clinical trial NCT00903851: Lidoderm® (Lidocaine Patch 5%) in Diabetic and Idiopathic Neuropathy
Official title: A Prospective, Open-label Trial of Lidoderm® (Lidocaine Patch 5%)in Painful Diabetic and Idiopathic Neuropathy.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Diabetes
Lead sponsor: Endo Pharmaceuticals
Sponsor class: INDUSTRY
First posted: 2009-05-19
Enrollment: 76
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: Mean change from baseline to Week 3 in average pain intensity as measured from patient diaries using Brief Pain Inventory Question 5.
timeFrame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56)
Secondary outcomes:
measure: McGill Pain Questionnaire
timeFrame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56)
measure: Other Pain Questions in BPI
timeFrame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56)
measure: Weekly pain intensity/relief measures
timeFrame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56)
measure: Pain duration using questions that assess duration and frequency of pain
timeFrame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56)
measure: Assessment of allodynia
timeFrame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56)
measure: Neuropathy Pain Scale
timeFrame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56)
measure: Assessment of safety was based on AEs, skin assessment, physical examination, vital signs, clinical laboratory data, and plasma lidocaine levels
timeFrame: Visits - V2 (Day 0), V3 (Day 7), V4 (Day 21), V5 (Day 35), V6/EOs (Day 56)
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Hueytown
country: United States
state: Alabama
city: Jacksonville
country: United States
state: Florida
city: Rochester
country: United States
state: New York
Study officials:
affiliation: Endo Pharmaceuticals
name: Study Director
role: STUDY_DIRECTOR
References: