Comparing Efficacy and Safety Between Eperisone a BID and a TID Regimen in Acute Low Back Pain Patients

Hanmi Pharmaceutical

Status and phase: Completed; Phase 2

Conditions: Low Back Pain

Treatments: Drug: Epirisone 50mg or placebo TID

Study type: Interventional

Funder types: Industry

Identifiers

NCT01806818

HM-EPAC-201

Details and patient eligibility

About

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.

Enrollment: 98 patients

Sex: All

Ages: 20 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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98 participants in 3 patient groups, including a placebo group

Eperisone 50mg BID

Experimental group

Description:

Administrate Eperisone 50mg tablet after the breakfast and dinner, and pacebo tablet after the lunch for 7 days

Treatment:

Drug: Epirisone 50mg or placebo TID

Epirisone 50mg TID

Experimental group

Treatment:

Drug: Epirisone 50mg or placebo TID

Placebo comparator

Placebo Comparator group

Treatment:

Drug: Epirisone 50mg or placebo TID