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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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24 October 2016 |
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Main ID: |
NCT02040415 |
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Date of registration:
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17/01/2014 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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Phase 3 Study to Evaluate the Efficacy and Safety of DW-1030 and Eperisone HCl in Acute Back Pain Patients
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Scientific title:
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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 |
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Date of first enrolment:
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March 2014 |
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Target sample size:
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242 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT02040415 |
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Study type:
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Interventional |
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Study design:
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Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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Phase:
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Phase 3
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Key inclusion & exclusion 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
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Both
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Health Condition(s) or Problem(s) studied
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Acute Back Pain
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Intervention(s)
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Drug: DW-1030(eperisone HCl) 75mg
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Drug: Placebo drug of DW-1030
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Drug: Placebo drug of Myonal Tab.
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Drug: Myonal Tab.(eperisone HCl) 50mg
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Primary Outcome(s)
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Changes of Finger-to-Floor Distance(FFD) compared to baseline 7days after administration
[Time Frame: 1, 3, 7 day]
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Secondary Outcome(s)
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Changes of 100mm Pain VAS
[Time Frame: -3, 1, 3, 7 day]
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Oswestry Disability Index (ODI)
[Time Frame: 1, 3, 7 day]
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Physician's Global Assessment
[Time Frame: 7 day]
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The number of using rescue drugs and the total amount
[Time Frame: 1, 3, 7 days]
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Secondary ID(s)
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DW-1030_301
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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