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
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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COMPLETED
PHASE3
242 participants
INTERVENTIONAL
2014-03-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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DW-1030(eperisone HCl)
DW-1030(eperisone HCl) 75mg BID
DW-1030(eperisone HCl) 75mg
Placebo drug of Myonal Tab.
Myonal Tab.(eperisone HCl)
Myonal Tab.(eperisone HCl) 50mg TID
Myonal Tab.(eperisone HCl) 50mg
Placebo drug of DW-1030
Interventions
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DW-1030(eperisone HCl) 75mg
Myonal Tab.(eperisone HCl) 50mg
Placebo drug of DW-1030
Placebo drug of Myonal Tab.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
No
Sponsors
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Daewon Pharmaceutical Co., Ltd.
INDUSTRY
Responsible Party
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Other Identifiers
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DW-1030_301
Identifier Type: -
Identifier Source: org_study_id
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