Diabetic Neuropathies
Conditions
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.
Interventions
Sponsors
NEMA Research, Inc.
Study design
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The Average Pain Score at target site. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
United States
Outcome results
None listed