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

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