This study was designed to evaluate the safety and efficacy of Cesamet™ in controlling pain in subjects experiencing pain due to diabetic peripheral neuropathy.
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.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
23
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, United States
The Average Pain Score at target site.
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.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.