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

Primary Purpose

Acute Back Pain

Status

Completed

Phase

Phase 3

Locations

Study Type

Interventional

Intervention

DW-1030(eperisone HCl) 75mg

Myonal Tab.(eperisone HCl) 50mg

Placebo drug of DW-1030

Placebo drug of Myonal Tab.

About this trial

This is an interventional treatment trial for Acute Back Pain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

DW-1030(eperisone HCl)

Myonal Tab.(eperisone HCl)

Arm Description

DW-1030(eperisone HCl) 75mg BID

Myonal Tab.(eperisone HCl) 50mg TID

Outcomes

Primary Outcome Measures

Changes of Finger-to-Floor Distance(FFD) compared to baseline 7days after administration

Secondary Outcome Measures

Changes of 100mm Pain VAS

Oswestry Disability Index (ODI)

Physician's Global Assessment

The number of using rescue drugs and the total amount

Full Information

NCT ID

NCT02040415

First Posted

January 17, 2014

Last Updated

October 11, 2016

Sponsor

Daewon Pharmaceutical Co., Ltd.

1. Study Identification

Unique Protocol Identification Number

NCT02040415

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

October 2016

Overall Recruitment Status

Completed

Study Start Date

March 2014 (undefined)

Primary Completion Date

July 2014 (Actual)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Daewon Pharmaceutical Co., Ltd.

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Back Pain

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

242 (Actual)

8. Arms, Groups, and Interventions

Arm Title

DW-1030(eperisone HCl)

Arm Type

Experimental

Arm Description

DW-1030(eperisone HCl) 75mg BID

Arm Title

Myonal Tab.(eperisone HCl)

Arm Type

Active Comparator

Arm Description

Myonal Tab.(eperisone HCl) 50mg TID

Intervention Type

Drug

Intervention Name(s)

DW-1030(eperisone HCl) 75mg

Intervention Type

Drug

Intervention Name(s)

Myonal Tab.(eperisone HCl) 50mg

Intervention Type

Drug

Intervention Name(s)

Placebo drug of DW-1030

Intervention Type

Drug

Intervention Name(s)

Placebo drug of Myonal Tab.

Primary Outcome Measure Information:

Title

Changes of Finger-to-Floor Distance(FFD) compared to baseline 7days after administration

Time Frame

1, 3, 7 day

Secondary Outcome Measure Information:

Title

Changes of 100mm Pain VAS

Time Frame

-3, 1, 3, 7 day

Title

Oswestry Disability Index (ODI)

Time Frame

1, 3, 7 day

Title

Physician's Global Assessment

Time Frame

7 day

Title

The number of using rescue drugs and the total amount

Time Frame

1, 3, 7 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility 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

12. IPD Sharing Statement

Learn more about this trial

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

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