Low Back Pain
Conditions
Brief summary
Multi-center Study to Compare Efficacy and Safety between Eperisone a BID and a TID Regimen in Acute Low Back Pain Patients during 7 days.
Interventions
DRUGEpirisone 50mg or placebo TID
3 times a day after meals for 1 week
Sponsors
Hanmi Pharmaceutical Company Limited
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Subjects who have ability to comprehend the contents of study and before participating in trial and have willingness to sign of informed consent in writing * 20≤ age ≤60 * A patient has symptom of acute low back pain * 4≤ VAS
Exclusion criteria
* Subjects who cannot prohibit anti-inflammatory drug, painkiller or muscle relaxants during clinical trial * 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS improvement of pain at rest, on movement and at night | 7 days |
Secondary
| Measure | Time frame |
|---|---|
| Change of Modified Schober test | 7 days |
| Change of Lateral Body Bending test | 7 days |
| Change of EuroQol by patients | 7 days |
| Change of Oswestry Disability Index | 7 days |
| Overall pain improvement by investigator | at last visit (D7+2) |
Countries
South Korea
Outcome results
None listed