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

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hanmi Pharmaceutical Company Limited
• Treatments: Eperisone

Criteria

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