MedTrace Logo

Efficacy and Safety of Tolperisone in Subjects With Pain Due to Acute Back Muscle Spasm

NCT04671082 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1004

Last updated 2022-03-22

No results posted yet for this study

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

  • Back Muscle Spasm
  • Back Pain
  • Back Strain
  • Back Spasm Upper
  • Muscle Spasm
  • Acute Pain

Interventions

DRUG

Tolperisone Hydrochloride

TID

DRUG

Placebo

TID

Sponsors & Collaborators

  • Neurana Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
64 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2020-12-15
Primary Completion
2021-12-13
Completion
2022-03-21
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04671082 on ClinicalTrials.gov