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Phase 3 Study to Evaluate the Efficacy and Safety of DW-1030 and Eperisone HCl in Acute Back Pain Patients

Daewon Pharmaceutical logo

Daewon Pharmaceutical

Status and phase

Completed
Phase 3

Conditions

Acute Back Pain

Treatments

Drug: Placebo drug of DW-1030
Drug: Myonal Tab.(eperisone HCl) 50mg
Drug: DW-1030(eperisone HCl) 75mg
Drug: Placebo drug of Myonal Tab.

Study type

Interventional

Funder types

Industry

Identifiers

NCT02040415
DW-1030_301

Details and patient eligibility

About

The purpose of this clinical study is to determine whether or not DW-1030 is not inferior to eperisone HCl in efficacy and safety.

Enrollment

242 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Adult males/Females aged over 18 years
  • Patients with symptom of Acute skeletomuscle myospasm and Back pain
  • Patients with Pain VAS Value over 40 mm in Visit 2
  • Subjects who voluntarily or legal guardian agreed with written consent

Exclusion criteria

  • Patients with Back pain caused by spinal spondylosis, spinal stenosis, fractures, cancer, severe arthritis, osteoporosis, sciatica, infection
  • Muscular patients such as myositis, muscular atrophy disease, increased muscle tone, myasthenia gravis
  • Patients who had taken invasive procedures such as epidural injections or spinal stimulation to cure the back pain within 6 months from the screening point
  • Patients who had taken passive physical therapy or ionphoresis within 12 hours from the screening point
  • Patients with severe GI tract disorder, heart disease, hypertension
  • Patients who had taken NSAIDS within 24hours from the screening point

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

242 participants in 2 patient groups

DW-1030(eperisone HCl)
Experimental group
Description:
DW-1030(eperisone HCl) 75mg BID
Treatment:
Drug: DW-1030(eperisone HCl) 75mg
Drug: Placebo drug of Myonal Tab.
Myonal Tab.(eperisone HCl)
Active Comparator group
Description:
Myonal Tab.(eperisone HCl) 50mg TID
Treatment:
Drug: Placebo drug of DW-1030
Drug: Myonal Tab.(eperisone HCl) 50mg

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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