Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Endo USA Inc., a Keenova Therapeutics Company | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The purpose of this study is to see if an investigational drug known as the lidocaine 5% patch is safe and effective in reducing the symptoms of diabetic neuropathy, to examine how topical lidocaine affects the nerve endings, and to determine whether treatment with the lidocaine patch can prevent the potential progression to chronic diabetic neuropathy pain in subjects who did not report pain at the start of the study.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy control patients | Other | Subjects 18 to 70 years of age, non-diabetic with no nervous system disease. Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study. |
|
| Type I or Type II diabetes with painful diabetic neuropathy | Other | 18 to 70 years old with significantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study. |
|
| patients with non-painful diabetic peripheral neuropathy | Other | 18-70 years of age with Type I or Type II diabetes with non-painful or insignificantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at baseline, 4 weeks, and end of study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Skin biopsy | Procedure | Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. |
| Measure | Description | Time Frame |
|---|---|---|
| Pain Scores From Composite Visual Analog Scale | Scores range from 0 to 10 with higher scores indicating higher levels of pain. | baseline, 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Keratinocyte Immunoreactivity of Nav1.6, Nav1.7, CGRP | Pixel intensity (0-256) of immunofluorescence for each individual biomarker. | Baseline, 4 weeks |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Albany Medical College | Albany | New York | 12208 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Healthy Control Patients | Subjects 18 to 70 years of age, non-diabetic with no nervous system disease. Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study. Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove. |
| FG001 | Type I or Type II Diabetes With Painful Diabetic Neuropathy | 18 to 70 years old with significantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study. Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove. |
| FG002 | Patients With Non-painful Diabetic Peripheral Neuropathy | 18-70 years of age with Type I or Type II diabetes with non-painful or insignificantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at baseline, 4 weeks, and end of study. Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Healthy Control Patients | Subjects 18 to 70 years of age, non-diabetic with no nervous system disease. Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study. Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Pain Scores From Composite Visual Analog Scale | Scores range from 0 to 10 with higher scores indicating higher levels of pain. | Healthy controls were not assessed for this measure. | Posted | Mean | Full Range | units on a scale | baseline, 4 weeks |
|
Not provided
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Healthy Control Patients | Subjects 18 to 70 years of age, non-diabetic with no nervous system disease. Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study. Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove. |
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Charles E. Argoff, MD | Albany Medical College | 518 262-0034 | argoffc@mail.amc.edu |
Not provided
| ID | Term |
|---|---|
| D008012 | Lidocaine |
| D057968 | Transdermal Patch |
| ID | Term |
|---|---|
| D000083 | Acetanilides |
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Lidocaine 5% patches | Drug | Subject will apply patches to affected area QD for 12 hours then remove. |
|
| Screen Failure |
|
| BG001 | Type I or Type II Diabetes With Painful Diabetic Neuropathy | 18 to 70 years old with significantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study. Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove. |
| BG002 | Patients With Non-painful Diabetic Peripheral Neuropathy | 18-70 years of age with Type I or Type II diabetes with non-painful or insignificantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at baseline, 4 weeks, and end of study. Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove. |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
18 to 70 years old with significantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study. Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove. |
| OG002 | Patients With Non-painful Diabetic Peripheral Neuropathy | 18-70 years of age with Type I or Type II diabetes with non-painful or insignificantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at baseline, 4 weeks, and end of study. Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove. |
|
|
| Secondary | Keratinocyte Immunoreactivity of Nav1.6, Nav1.7, CGRP | Pixel intensity (0-256) of immunofluorescence for each individual biomarker. | Posted | Mean | Full Range | Pixel intensity (0-256) | Baseline, 4 weeks |
|
|
|
| 0 |
| 11 |
| 0 |
| 11 |
| EG001 | Type I or Type II Diabetes With Painful Diabetic Neuropathy | 18 to 70 years old with significantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at biaseline and end of study. Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove. | 0 | 21 | 0 | 21 |
| EG002 | Patients With Non-painful Diabetic Peripheral Neuropathy | 18-70 years of age with Type I or Type II diabetes with non-painful or insignificantly painful diabetic neuropathy.Lidocaine 5% patch applied to both feet daily, Skin biopsies at baseline, 4 weeks, and end of study. Skin biopsy: Skin biopsy specimens will processed and analyzed for Nerve fiber count, nerve and skin morphology, and sodium channel specific epitope expression in keratinocytes. Lidocaine 5% patches: Subject will apply patches to affected area QD for 12 hours then remove. | 0 | 12 | 0 | 12 |
Not provided
Not provided
| Aniline Compounds |
| D000588 | Amines |
| D004864 | Equipment and Supplies |
|
| Nav1.7-baseline |
|
| Nav1.7-4 weeks |
|
| CGRP-baseline |
|
| CGRP-4 weeks |
|