Status:
COMPLETED
Comparing Efficacy and Safety Between Eperisone a BID and a TID Regimen in Acute Low Back Pain Patients
Lead Sponsor:
Hanmi Pharmaceutical Company Limited
Conditions:
Low Back Pain
Eligibility:
All Genders
20-60 years
Phase:
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
February 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2013
Estimated Enrollment :
98 Patients enrolled
Trial Details
Trial ID
NCT01806818
Start Date
February 1 2013
End Date
July 1 2013
Last Update
August 23 2013
Active Locations (5)
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1
Hallym University Sacred Heart Hospital
Anyang, South Korea
2
CHA Bundang Medical Center
Seoul, South Korea
3
Kyung Hee University Hospital
Seoul, South Korea
4
Medical college of Yonsei University, Gangnam Severance Hospital
Seoul, South Korea