NCT02040415

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
242

participants targeted

Target at P50-P75 for phase_3

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 17, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 20, 2014

Completed
1 month until next milestone

Study Start

First participant enrolled

March 1, 2014

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Last Updated

October 12, 2016

Status Verified

October 1, 2016

Enrollment Period

4 months

First QC Date

January 17, 2014

Last Update Submit

October 11, 2016

Conditions

Acute Back Pain

Outcome Measures

Primary Outcomes (1)

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

    1, 3, 7 day

Secondary Outcomes (4)

  • 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

Study Arms (2)

DW-1030(eperisone HCl)

EXPERIMENTAL

DW-1030(eperisone HCl) 75mg BID

Drug: DW-1030(eperisone HCl) 75mgDrug: Placebo drug of Myonal Tab.

Myonal Tab.(eperisone HCl)

ACTIVE COMPARATOR

Myonal Tab.(eperisone HCl) 50mg TID

Drug: Myonal Tab.(eperisone HCl) 50mgDrug: Placebo drug of DW-1030

Interventions

DW-1030(eperisone HCl) 75mgDRUG
DW-1030(eperisone HCl)
Myonal Tab.(eperisone HCl) 50mgDRUG
Myonal Tab.(eperisone HCl)
Placebo drug of DW-1030DRUG
Myonal Tab.(eperisone HCl)
Placebo drug of Myonal Tab.DRUG
DW-1030(eperisone HCl)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 17, 2014

First Posted

January 20, 2014

Study Start

March 1, 2014

Primary Completion

July 1, 2014

Last Updated

October 12, 2016

Record last verified: 2016-10