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

NEMA Research

Status and phase: Completed; Phase 4

Conditions: Diabetic Neuropathies

Treatments: Drug: Cesamet™ (nabilone)

Study type: Interventional

Funder types: Industry

Identifiers

NCT00380913

CB1 Study 001

Details and patient eligibility

About

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 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.

Enrollment: 23 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)