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NCT00380913 Clinical Trial

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

Diabetic Neuropathies Clinical Trial

Official title:
A Multicenter Trial Evaluating the Efficacy of Cesamet™ for the Symptomatic Treatment of Pain in Patients With Diabetic Peripheral Neuropathy

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00380913
Other study ID # CB1 Study 001
Secondary ID
Status Completed
Phase Phase 4
First received September 25, 2006
Last updated February 14, 2008
Start date September 2006
Est. completion date October 2007

Study information
Verified date February 2008
Source NEMA Research, Inc.
Contact n/a
Is FDA regulated No
Health authority United States: Institutional Review Board
Study type Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility
Status Completed
Enrollment 23
Est. completion date October 2007
Est. primary completion date October 2007
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 75 Years
Eligibility 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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Drug:
• Cesamet™ (nabilone)

Locations
Country Name City State
United States South Florida Medical Research Aventura Florida
United States Sunrise Clinical Research, Inc. Hollywood Florida
United States Naples Anesthesia and Pain Associates Naples Florida
United States Lazlo Mate, MD West Palm Beach Florida

Sponsors (1)
Lead Sponsor Collaborator
NEMA Research, Inc.

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary The Average Pain Score at target site.
Secondary The Worst Pain Score at target site.
Secondary The Pain at Night Score at target site.
Secondary Quality of Life measures
Secondary Patient satisfaction with treatment
Secondary Safety will be assessed through the collection of AEs and vital signs.
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