Diabetic Neuropathy, Pain
Conditions
Keywords
distal symmetrical, pain, lower extremities, dextromethorphan
Brief summary
The purpose of this study is to determine whether dextromethorphan (Neurodex) and quinidine are effective in the treatment of pain of diabetic neuropathy.
Interventions
DRUGNeurodex
Sponsors
Avanir Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
Inclusion criteria
* Diagnosis of diabetes mellitus * Established diabetic therapy for at least 3 months * Lab-supported diagnosis of painful diabetic distal symmetric sensory/motor polyneuropathy * Pain the previous three months * Not pregnant
Exclusion criteria
* Patient failed adequate trial of 3 or more medications or has required narcotics for pain * History of torsades de pointes * Sensitivity to quinidine or opiate drugs (codeine, etc) * Severe pain that could confound the assessment * Patient has had any amputations * Patient has participated in the past 30 days or is currently participating in another trial * Patient has previously received treatment with dextromethorphan and quinidine
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain rating scale obtained from patient diaries | — |
Secondary
| Measure | Time frame |
|---|---|
| Additional diary rating scales and scores obtained from clinic visits | — |
Countries
United States
Outcome results
None listed