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

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT02040415

Enrollment

242

Registered

2014-01-20

Start date

2014-03-31

Completion date

Unknown

Last updated

2016-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Back Pain

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.

Interventions

DRUGDW-1030(eperisone HCl) 75mg

DRUGMyonal Tab.(eperisone HCl) 50mg

DRUGPlacebo drug of DW-1030

DRUGPlacebo drug of Myonal Tab.

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

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

Design outcomes

Primary

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

Secondary

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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026