Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a multicenter, randomized, placebo-controlled, parallel group study of EpiCept™ NP-1 Topical Cream (amitriptyline 4%/ketamine 2%) in approximately 200 patients with pain in the lower extremities due to diabetic nerve pain.
This is a phase II, multicenter, randomized, placebo-controlled, parallel group study of EpiCept™ NP-1 Topical Cream (amitriptyline 4%/ketamine 2%) in approximately 200 patients with chronic pain in the lower extremities due to diabetic peripheral neuropathy (DPN).
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| placebo cream | Placebo Comparator | vehicle cream |
|
| amitriptyline 4% ketamine 2% cream | Active Comparator | active topical cream |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream | Drug | topical cream applied daily for 4 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks. | diabetic peripheral neuropathy (DPN) pain is recorded on a numerical rating scale of 0 (no pain) to 10 (worst possible pain) at baseline and the endpoint of 4 weeks. | baseline and 4 weeks treatment |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Robert H Dworkin, Ph.D. | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Multiple Centers | New Delhi | India |
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Placebo Cream | vehicle cream applied twice daily for 4 weeks |
| FG001 | Amitriptyline 4% Ketamine 2% Cream | active topical cream applied twice daily for 4 weeks |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| placebo cream | Drug | inactive placebo cream applied two times daily |
|
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Placebo Cream | vehicle cream applied twice daily for 4 weeks |
| BG001 | Amitriptyline 4% Ketamine 2% Cream | active topical cream applied twice daily for 4 weeks |
| BG002 | Total | Total of all reporting groups |
| 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 | Participants |
| ||||||||||||||||||
| Age Continuous | Mean | Standard Deviation | years |
| |||||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||||
| Region of Enrollment | Number | 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 | Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks. | diabetic peripheral neuropathy (DPN) pain is recorded on a numerical rating scale of 0 (no pain) to 10 (worst possible pain) at baseline and the endpoint of 4 weeks. | ITT (Intention To Treat) completer population, LOCF (Last Observation Carried Forward) imputation | Posted | Least Squares Mean | 95% Confidence Interval | units on a scale | baseline and 4 weeks treatment |
|
|
|
|
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 | Placebo Cream | vehicle cream applied twice daily for 4 weeks | 0 | 112 | 16 | 112 | ||
| EG001 | Amitriptyline 4% Ketamine 2% Cream | active topical cream applied twice daily for 4 weeks | 0 | 114 | 17 | 114 |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Eosiniphilia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Anemia | Blood and lymphatic system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Conjunctivitis | Eye disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pain | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pyrexia | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Edema | General disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Rhinitis | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Upper Respiratory Infection | Infections and infestations | MedDRA 10.0 | Systematic Assessment |
| |
| Aspartate aminotransferase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Blood lactate dehydrogenase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Blood urea increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Alanine aminotransferase increased | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Body temperature fluctuation | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Electrocardiogram QT prolonged | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Urine analysis abnormal | Investigations | MedDRA 10.0 | Systematic Assessment |
| |
| Hyperkalemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hypocalcemia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Hyponatremia | Metabolism and nutrition disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Headache | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Paresthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Somnolence | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dysesthesia | Nervous system disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pyuria | Renal and urinary disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Pruritus | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Rash | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Dry skin | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Skin exfoliation | Skin and subcutaneous tissue disorders | MedDRA 10.0 | Systematic Assessment |
| |
| Flushing | Vascular disorders | MedDRA 10.0 | Systematic Assessment |
|
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | EpiCept Corporation | 914-606-3500 | deverton@epicept.com |
| ID | Term |
|---|---|
| D009437 | Neuralgia |
| ID | Term |
|---|---|
| D010523 | Peripheral Nervous System Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| D000639 | Amitriptyline |
| D007649 | Ketamine |
| ID | Term |
|---|---|
| D003986 | Dibenzocycloheptenes |
| D001567 | Benzocycloheptenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |
| D003510 | Cyclohexanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
Not provided
Not provided
| >=65 years |
|
| Male |
|