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

• Status: Completed
• Trial end date: 1969-12-31
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.
• Treatments: Eperisone

Criteria

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