Back to resultsEvaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Diabetic Peripheral Neuropathy
Primary Purpose
Diabetic Neuropathies
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Cesamet™ (nabilone)
Sponsored by
About this trial
This is an interventional treatment trial for Diabetic Neuropathies
Eligibility Criteria
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
Sites / Locations
- South Florida Medical Research
- Sunrise Clinical Research, Inc.
- Naples Anesthesia and Pain Associates
- Lazlo Mate, MD
Outcomes
Primary Outcome Measures
The Average Pain Score at target site.
Secondary Outcome 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.
Full Information
NCT ID
NCT00380913
First Posted
September 25, 2006
Last Updated
February 14, 2008
Sponsor
NEMA Research, Inc.
1. Study Identification
Unique Protocol Identification Number
NCT00380913
Brief Title
Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Diabetic Peripheral Neuropathy
Official Title
A Multicenter Trial Evaluating the Efficacy of Cesamet™ for the Symptomatic Treatment of Pain in Patients With Diabetic Peripheral Neuropathy
Study Type
Interventional
2. Study Status
Record Verification Date
February 2008
Overall Recruitment Status
Completed
Study Start Date
September 2006 (undefined)
Primary Completion Date
October 2007 (Actual)
Study Completion Date
October 2007 (Actual)
3. Sponsor/Collaborators
Name of the Sponsor
NEMA Research, Inc.
4. Oversight
5. Study Description
Brief Summary
This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain in subjects experiencing pain due to diabetic peripheral neuropathy.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Neuropathies
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
23 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Cesamet™ (nabilone)
Primary Outcome Measure Information:
Title
The Average Pain Score at target site.
Secondary Outcome Measure Information:
Title
The Worst Pain Score at target site.
Title
The Pain at Night Score at target site.
Title
Quality of Life measures
Title
Patient satisfaction with treatment
Title
Safety will be assessed through the collection of AEs and vital signs.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joseph V Pergolizzi, MD
Organizational Affiliation
NEMA Research, Inc.
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Charlotte Richmond, PhD
Organizational Affiliation
Nema Research
Official's Role
Study Director
Facility Information:
Facility Name
South Florida Medical Research
City
Aventura
State/Province
Florida
ZIP/Postal Code
33180
Country
United States
Facility Name
Sunrise Clinical Research, Inc.
City
Hollywood
State/Province
Florida
ZIP/Postal Code
33021
Country
United States
Facility Name
Naples Anesthesia and Pain Associates
City
Naples
State/Province
Florida
ZIP/Postal Code
34108
Country
United States
Facility Name
Lazlo Mate, MD
City
West Palm Beach
State/Province
Florida
ZIP/Postal Code
33407
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.nema.net
Description
Nema Research website
Learn more about this trial
Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Diabetic Peripheral Neuropathy
We'll reach out to this number within 24 hrs