drugset / Trial / NCT03664921
Omnitram Safety and Efficacy in the Treatment of Diabetic Neuropathy
Phase 2
Completed
55 enrolled
Syntrix Biosystems, Inc.
DFNet Research Inc. · collabNational Institute on Drug Abuse (NIDA) · collab
RandomizedCrossoverQuadruple-blindTreatment
Summary
This study evaluates the analgesic effect of Omnitram for the treatment of painful diabetic neuropathy. Each subject with diabetic neuropathy will be treated for four weeks with Omnitram and for four weeks with placebo. The order of the Omnitram and placebo treatment will be random.
Timeline
- Start
- 2018-11-15
- Primary completion
- 2020-08-17
- Completion
- 2020-08-17
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Desmetramadol | Small molecule | 30 mg | Oral |
| Subject | Desmetramadol | Small molecule | 60 mg | Oral |
| Subject | Desmetramadol | Small molecule | 90 mg | Oral |
| Subject | Desmetramadol | Small molecule | 120 mg | Oral |