Trials / Completed
CompletedNCT04671082
Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm
A Phase 3, 14-Day, Double-blind, Randomized, Placebo-Controlled, Multicenter Study of the Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 1,004 (actual)
- Sponsor
- Neurana Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 64 Years
- Healthy volunteers
- Not accepted
Summary
This is a double-blind, randomized, placebo-controlled, multicenter study of the efficacy and safety of tolperisone (a non-opioid) or placebo administered in subjects with pain due to acute back muscle spasm.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Tolperisone Hydrochloride | TID |
| DRUG | Placebo | TID |
Timeline
- Start date
- 2020-12-15
- Primary completion
- 2021-12-13
- Completion
- 2022-03-21
- First posted
- 2020-12-17
- Last updated
- 2022-03-22
Locations
56 sites across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04671082. Inclusion in this directory is not an endorsement.