A Study of the Efficacy and Safety of Amitriptyline/Ketamine Topical Cream in Patients With Diabetic Peripheral Neuropathy
Information source: EpiCept Corporation
Information obtained from ClinicalTrials.gov on June 20, 2008
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Diabetic Peripheral Neuropathy; Neuralgia
Intervention: Amitriptyline/Ketamine Topical Cream (Drug)
Phase: Phase 2
Status: Completed
Sponsored by: EpiCept Corporation Official(s) and/or principal investigator(s):
Robert H Dworkin, Ph.D., Principal Investigator, Affiliation: University of Rochester
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.
Clinical Details
Official title: 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)
Study design: Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: The objective of this study is to evaluate the efficacy and safety of EpiCept™ NP-1 Topical Cream compared with placebo in patients with pain due to DPN by examining daily pain intensity scores.
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.
Eligibility
Minimum age: 18 Years.
Maximum age: N/A.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Adult patients with chronic pain due to 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
Locations and Contacts
Multiple Centers, New Delhi, India
Additional Information
Starting date: July 2007
Ending date: April 2008
Last updated: April 21, 2008
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