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

Acute Back Pain Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02040415
• Other study ID #: DW-1030_301
• Status: Completed
• Phase: Phase 3
• First received: January 17, 2014
• Last updated: October 11, 2016
• Start date: March 2014

Study information

• Verified date: October 2016
• Source: Daewon Pharmaceutical Co., Ltd.
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Korea Food and Drug Administration (KFDA)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 242
• Est. primary completion date: July 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Back Pain
• Back Pain

Intervention

Drug:
• DW-1030(eperisone HCl) 75mg

• Myonal Tab.(eperisone HCl) 50mg

• Placebo drug of DW-1030

• Placebo drug of Myonal Tab.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Daewon Pharmaceutical Co., Ltd.

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of Finger-to-Floor Distance(FFD) compared to baseline 7days after administration		1, 3, 7 day	No
Secondary	Changes of 100mm Pain VAS		-3, 1, 3, 7 day	No
Secondary	Oswestry Disability Index (ODI)		1, 3, 7 day	No
Secondary	Physician's Global Assessment		7 day	No
Secondary	The number of using rescue drugs and the total amount		1, 3, 7 days	No