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Tolperisone in Acute Muscle Spasm of the Back

NCT03802565 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 415

Last updated 2022-02-01

Study results available
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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.

Conditions

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

Interventions

DRUG

Tolperisone

TID

DRUG

Placebo

Placebo

Sponsors & Collaborators

  • Neurana Pharmaceuticals, Inc.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-02-01
Primary Completion
2019-06-28
Completion
2019-07-12
FDA Drug
Yes

Countries

  • United States

Study Locations

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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 NCT03802565 on ClinicalTrials.gov