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

Phase 3

Completed

• Conditions: Acute Back Pain
• Interventions: Drug: Myonal Tab.(eperisone HCl) 50mg; Drug: DW-1030(eperisone HCl) 75mg; Drug: Placebo drug of DW-1030; Drug: Placebo drug of Myonal Tab.

• Registration Number: NCT02040415
• Lead Sponsor: Daewon Pharmaceutical Co., Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2014-01-17
• Study First Submitted QC: 2014-01-17
• Study First Posted: 2014-01-20
• Study Start: 2014-03
• Primary Completion: 2014-07
• Status Verified: 2016-10
• Last Update Submitted: 2016-10-11
• Last Update Posted: 2016-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 242

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Myonal Tab.(eperisone HCl)	Myonal Tab.(eperisone HCl) 50mg	Myonal Tab.(eperisone HCl) 50mg TID
Myonal Tab.(eperisone HCl)	Placebo drug of DW-1030	Myonal Tab.(eperisone HCl) 50mg TID
DW-1030(eperisone HCl)	DW-1030(eperisone HCl) 75mg	DW-1030(eperisone HCl) 75mg BID
DW-1030(eperisone HCl)	Placebo drug of Myonal Tab.	DW-1030(eperisone HCl) 75mg BID

Primary Outcome Measures

Name	Time	Method
Changes of Finger-to-Floor Distance(FFD) compared to baseline 7days after administration	1, 3, 7 day

Secondary Outcome Measures

Name	Time	Method
Changes of 100mm Pain VAS	-3, 1, 3, 7 day
Oswestry Disability Index (ODI)	1, 3, 7 day
The number of using rescue drugs and the total amount	1, 3, 7 days
Physician's Global Assessment	7 day