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.
A Study of the Efficacy and Safety of Amitriptyline/Ketamine Topical Cream in Patients With Diabetic Peripheral Neuropathy
Brief Summary
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.
Intervention / Treatment
-
EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream (DRUG)topical cream applied daily for 4 weeks
-
placebo cream (DRUG)inactive placebo cream applied two times daily
Condition or Disease
- Diabetic Peripheral Neuropathy
- Neuralgia
Phase
Study Design
| Study type: | INTERVENTIONAL |
|---|---|
| Status: | Completed |
| Study results: | No Results Available |
| Age: | 18 Years and older (Adult, Older Adult) |
| Enrollment: | 226 (ACTUAL) |
| Funded by: | Industry |
| Allocation: | Randomized |
| Primary Purpose: | Treatment |
Masking |
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Clinical Trial Dates
| Start date: | Jul 01, 2007 | |
|---|---|---|
| Primary Completion: | Apr 01, 2008 | ACTUAL |
| Completion Date: | Apr 01, 2008 | ACTUAL |
| Study First Posted: | May 21, 2007 | ESTIMATED |
| Results First Posted: | May 17, 2011 | ESTIMATED |
| Last Updated: | Apr 19, 2011 |
Sponsors / Collaborators
Lead Sponsor:
N/A
Responsible Party:
N/A
Location
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).
Eligibility Criteria
| Sex: | All |
|---|---|
| Minimum Age: | 18 |
| Healthy Volunteers: | Yes |
Inclusion Criteria:
* Adult patients with chronic pain due to diabetic peripheral neuropathy (DPN) of at least 6 months duration are eligible if they have an average daily pain score of \> 4 during the baseline week.
Exclusion Criteria:
* Clinically significant intercurrent illness (e.g., endocrine, cardiac, hepatic, renal, neurologic, hematologic, skeletal) that the investigator determines could interfere with the efficacy or safety assessments in this study
* Adult patients with chronic pain due to diabetic peripheral neuropathy (DPN) of at least 6 months duration are eligible if they have an average daily pain score of \> 4 during the baseline week.
Exclusion Criteria:
* Clinically significant intercurrent illness (e.g., endocrine, cardiac, hepatic, renal, neurologic, hematologic, skeletal) that the investigator determines could interfere with the efficacy or safety assessments in this study
Primary Outcomes
More Details
| NCT Number: | NCT00476151 |
|---|---|
| Other IDs: | EPC2006-01 |
| Study URL: | https://clinicaltrials.gov/study/NCT00476151 |
Last updated: Sep 29, 2023