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

NCT ID: NCT02040415

Last Updated: 2016-10-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

242 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-03-31

Brief Summary

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The purpose of this clinical study is to determine whether or not DW-1030 is not inferior to eperisone HCl in efficacy and safety.

Detailed Description

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Conditions

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Acute Back Pain

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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DW-1030(eperisone HCl)

DW-1030(eperisone HCl) 75mg BID

Group Type EXPERIMENTAL

DW-1030(eperisone HCl) 75mg

Intervention Type DRUG

Placebo drug of Myonal Tab.

Intervention Type DRUG

Myonal Tab.(eperisone HCl)

Myonal Tab.(eperisone HCl) 50mg TID

Group Type ACTIVE_COMPARATOR

Myonal Tab.(eperisone HCl) 50mg

Intervention Type DRUG

Placebo drug of DW-1030

Intervention Type DRUG

Interventions

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DW-1030(eperisone HCl) 75mg

Intervention Type DRUG

Myonal Tab.(eperisone HCl) 50mg

Intervention Type DRUG

Placebo drug of DW-1030

Intervention Type DRUG

Placebo drug of Myonal Tab.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Daewon Pharmaceutical Co., Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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DW-1030_301

Identifier Type: -

Identifier Source: org_study_id

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