Evaluation of the Efficacy of Cesamet™ for the Treatment of Pain in Patients With Diabetic Peripheral Neuropathy
- Conditions
- Diabetic Neuropathies
- Registration Number
- NCT00380913
- Lead Sponsor
- NEMA Research, Inc.
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 23
- 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
- Hypersensitivity to compounds in study drug or similar drugs
- Pregnant or lactating females
- Drug or alcohol abuse
- Unstable medical condition
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Primary Outcome Measures
Name Time Method The Average Pain Score at target site.
- Secondary Outcome Measures
Name Time Method 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.
Trial Locations
- Locations (4)
Naples Anesthesia and Pain Associates
🇺🇸Naples, Florida, United States
South Florida Medical Research
🇺🇸Aventura, Florida, United States
Sunrise Clinical Research, Inc.
🇺🇸Hollywood, Florida, United States
Lazlo Mate, MD
🇺🇸West Palm Beach, Florida, United States