Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Diabetic Peripheral Neuropathy

Overview

This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain in subjects experiencing pain due to diabetic peripheral neuropathy.

Full Title of Study: “A Multicenter Trial Evaluating the Efficacy of Cesamet™ for the Symptomatic Treatment of Pain in Patients With Diabetic Peripheral Neuropathy”

Study Type

  • Study Type: Interventional
  • Study Design
    • Allocation: Non-Randomized
    • Intervention Model: Single Group Assignment
    • Primary Purpose: Treatment
    • Masking: None (Open Label)
  • Study Primary Completion Date: October 2007

Detailed Description

The purpose of this study is to determine the safety and efficacy of Cesamet™ in the symptomatic treatment of pain due to diabetic peripheral neuropathy. This is a phase IV, multi-center, open label outpatient clinical trial evaluating Cesamet™ treatment for control of pain due diabetic peripheral neuropathy. The study has two phases: a Pretreatment Phase and a Treatment Phase.

Interventions

  • Drug: Cesamet™ (nabilone)

Clinical Trial Outcome Measures

Primary Measures

  • The Average Pain Score at target site.

Secondary Measures

  • The Worst Pain Score at target site.
  • The Pain at Night Score at target site.
  • Quality of Life measures
  • Patient satisfaction with treatment
  • Safety will be assessed through the collection of AEs and vital signs.

Participating in This Clinical Trial

Inclusion Criteria

  • Patients with diabetic peripheral neuropathic pain – Chronic daily pain present for at least 2 months – On stable analgesic regimen for one month – Baseline pain score greater than 40mm on a visual analog scale Exclusion Criteria:

  • Hypersensitivity to compounds in study drug or similar drugs – Pregnant or lactating females – Drug or alcohol abuse – Unstable medical condition

Gender Eligibility: All

Minimum Age: 18 Years

Maximum Age: 75 Years

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • NEMA Research, Inc.
  • Provider of Information About this Clinical Study
    • Joseph Pergolizzi, MD, NEMA Research
  • Overall Official(s)
    • Joseph V Pergolizzi, MD, Principal Investigator, NEMA Research, Inc.
    • Charlotte Richmond, PhD, Study Director, Nema Research

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