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

A Multicenter, Randomized, Double-blinded, Parallel, Active-controlled, Phase Lll Clinical Trial to Evaluate the Efficacy and Safety of DW-1030 and Eperisone HCl in Acute Back Pain Patients

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

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