A Study of the Efficacy and Safety of Amitriptyline/Ketamine Topical Cream in Patients With Diabetic Peripheral Neuropathy

Phase 2

Completed

• Conditions: Neuralgia; Diabetic Peripheral Neuropathy
• Interventions: Drug: EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream; Drug: placebo cream

• Registration Number: NCT00476151
• Lead Sponsor: EpiCept Corporation

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.

Detailed Description

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).

Study Timeline

• Study First Submitted: 2007-05-17
• Study First Submitted QC: 2007-05-18
• Study First Posted: 2007-05-21
• Study Start: 2007-07
• Primary Completion: 2008-04
• Study Completion: 2008-04
• Results First Submitted: 2010-09-28
• Status Verified: 2011-04
• Results First Submitted QC: 2011-04-19
• Last Update Submitted: 2011-04-19
• Results First Posted: 2011-05-17
• Last Update Posted: 2011-05-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 226

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
amitriptyline 4% ketamine 2% cream	EpiCept NP-1 (4% Amitriptyline/ 2% Ketamine) Topical Cream	active topical cream
placebo cream	placebo cream	vehicle cream

Primary Outcome Measures

Name	Time	Method
Placebo vs. Active Comparison of the Change From Average Pain at Baseline to Average Pain at 4 Weeks.	baseline and 4 weeks treatment	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.

Trial Locations

Locations (1)

Multiple Centers; 🇮🇳 New Delhi, India