drugset / Trial / NCT02644421
Clinical Trial to Evaluate the Safety and Analgesic Efficacy of VVZ-149 in Lumbar Radiculopathy (Sciatica)
RandomizedCrossoverQuadruple-blindTreatment
Summary
Double-blind, crossover, randomized, 3x3 Latin square, placebo-controlled study of single intravenous dose administration of VVZ-149. To demonstrate assay sensitivity, lidocaine will be administered as a positive control. The study will take place during a single inpatient visit involving three separate treatment periods, each with a washout of (\>16-hours. Study drugs (VVZ-149 vs. lidocaine vs. normal saline, NS) will be administered intravenously.
Timeline
- Start
- 2015-11
- Primary completion
- 2017-07
- Completion
- 2017-07
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Lidocaine | Other / unclassified | 4 mg/kg | Intravenous |
| Subject | VVZ-149 | Small molecule | 1.3 mg/kg | Intravenous |