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.

Study Overview

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

• Study Type: Interventional
• Enrollment (Actual): 242
• Phase: Phase 3

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: DW-1030(eperisone HCl); DW-1030(eperisone HCl) 75mg BID	Drug: DW-1030(eperisone HCl) 75mg; Drug: Placebo drug of Myonal Tab.
Active Comparator: Myonal Tab.(eperisone HCl); Myonal Tab.(eperisone HCl) 50mg TID	Drug: Myonal Tab.(eperisone HCl) 50mg; Drug: Placebo drug of DW-1030

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Daewon Pharmaceutical Co., Ltd.

Study record dates

Study Major Dates

• Study Start: March 1, 2014
• Primary Completion (Actual): July 1, 2014

Study Registration Dates

• First Submitted: January 17, 2014
• First Submitted That Met QC Criteria: January 17, 2014
• First Posted (Estimate): January 20, 2014

Study Record Updates

• Last Update Posted (Estimate): October 12, 2016
• Last Update Submitted That Met QC Criteria: October 11, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Vasodilator Agents; Parasympatholytics; Autonomic Agents; Peripheral Nervous System Agents; Membrane Transport Modulators; Anticonvulsants; Calcium-Regulating Hormones and Agents; Calcium Channel Blockers; Neuromuscular Agents; Muscle Relaxants, Central; Eperisone
• Other Study ID Numbers: DW-1030_301