Comparing Efficacy and Safety Between Eperisone a BID and a TID Regimen in Acute Low Back Pain Patients
NCT ID: NCT01806818
Last Updated: 2013-08-23
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
PHASE2
98 participants
INTERVENTIONAL
2013-02-28
2013-07-31
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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Eperisone 50mg BID
Administrate Eperisone 50mg tablet after the breakfast and dinner, and pacebo tablet after the lunch for 7 days
Epirisone 50mg or placebo TID
3 times a day after meals for 1 week
Epirisone 50mg TID
Epirisone 50mg or placebo TID
3 times a day after meals for 1 week
Placebo comparator
Epirisone 50mg or placebo TID
3 times a day after meals for 1 week
Interventions
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Epirisone 50mg or placebo TID
3 times a day after meals for 1 week
Eligibility Criteria
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Inclusion Criteria
* 20≤ age ≤60
* A patient has symptom of acute low back pain
* 4≤ VAS
Exclusion Criteria
* Chronic rheumatoid arthritis patients
* Patients having a medical history of hypersensitivity to Eperisone Hydrochloride
* Subject having a hereditary problem such as galactose intolerance, Lapp lactase deficiency, or glucose galatose malabsorption
* Participation in other studies before 60 days of first dosing
* Female patients having positive pregnancy test, lactating women,planning pregnancy during clinical trial
* Inadequate subject for the clinical trial by the investigator's decision
20 Years
60 Years
ALL
No
Sponsors
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Hanmi Pharmaceutical Company Limited
INDUSTRY
Responsible Party
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Principal Investigators
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Hak-Sun Kim, M.D.
Role: PRINCIPAL_INVESTIGATOR
Gangnam Severance Hospital
Locations
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Hallym University Sacred Heart Hospital
Anyang, , South Korea
CHA Bundang Medical Center
Seoul, , South Korea
Kyung Hee University Hospital
Seoul, , South Korea
Medical college of Yonsei University, Gangnam Severance Hospital
Seoul, , South Korea
Severance Hospital
Seoul, , South Korea
Countries
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Other Identifiers
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HM-EPAC-201
Identifier Type: -
Identifier Source: org_study_id