Phase 2
Completed N=226
A Study of the Efficacy and Safety of Amitriptyline/Ketamine Topical Cream in Patients With Diabetic Peripheral Neuropathy
Diabetic Peripheral Neuropathy · Neuralgia
Source: ClinicalTrials.gov NCT00476151 ↗
Enrolled (actual)
226
Serious AEs
0.0%
Results posted
May 2011
Primary outcomePrimary: Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks. — 1.64; 2.12 units on a scale — p=0.083
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks. |
1.64; 2.12 | 0.083 |
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT00476151). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.