At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 226 enrolled
Drug / intervention
EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Multicenter, Double-Blind, Randomized, Placebo-Controlled Study of the Efficacy and Safety of EpiCept™ NP-1 Topical Cream in Patients With Pain From Diabetic Peripheral Neuropathy (DPN)
In Brief
A Phase 2 clinical trial evaluating EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream and placebo cream for Diabetic Peripheral Neuropathy and Neuralgia. Completed, enrolled 226 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsDiabetic Peripheral Neuropathy, Neuralgia
CountriesIndia
Collaborators--
Timeline
Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedMay 2007
Enrollment StartJul 2007
Primary CompletionApr 2008
TodayJul 2026
First PostedMay 21, 2007
Enrollment StartJul 1, 2007
Primary CompletionApr 1, 2008
TodayJul 2, 2026
Enrollment to primary: 9 monthsPosted 19.1 years ago
Interventions
EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Creamdrug
topical cream applied daily for 4 weeks
placebo creamdrug
inactive placebo cream applied two times daily