drugset / Trial / NCT03802565
Tolperisone in Acute Muscle Spasm of the Back
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a double-blind, randomized, placebo-controlled, parallel group study of the efficacy and safety of tolperisone (a non-opioid) or placebo administered as multiple doses three times a day (TID) in approximately 400 male and female subjects experiencing back pain due to or associated with muscle spasm.
Timeline
- Start
- 2019-02-01
- Primary completion
- 2019-06-28
- Completion
- 2019-07-12
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Tolperisone | Small molecule | 50 mg | — |
| Subject | Tolperisone | Small molecule | 100 mg | — |
| Subject | Tolperisone | Small molecule | 150 mg | — |
| Subject | Tolperisone | Small molecule | 200 mg | — |
Indications
No indication recorded.