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

Low Back Pain Clinical Trial

Official title:

A Phase 2, Randomized, Double-blind, Parallel, Placebo-controlled, Multi-center Study to Compare Efficacy and Safety Between Eperisone a BID and a TID Regimen in Acute Low Back Pain Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01806818
• Other study ID #: HM-EPAC-201
• Status: Completed
• Phase: Phase 2
• First received: March 6, 2013
• Last updated: August 22, 2013
• Start date: February 2013
• Est. completion date: July 2013

Study information

• Verified date: August 2013
• Source: Hanmi Pharmaceutical Company Limited
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 98
• Est. completion date: July 2013
• Est. primary completion date: July 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 60 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Back Pain
• Low Back Pain

Intervention

Drug:
• Epirisone 50mg or placebo TID
3 times a day after meals for 1 week

Locations

Country	Name	City	State
Korea, Republic of	Hallym University Sacred Heart Hospital	Anyang
Korea, Republic of	CHA Bundang Medical Center	Seoul
Korea, Republic of	Kyung Hee University Hospital	Seoul
Korea, Republic of	Medical college of Yonsei University, Gangnam Severance Hospital	Seoul
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Hanmi Pharmaceutical Company Limited

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	VAS improvement of pain at rest, on movement and at night		7 days	No
Secondary	Change of Modified Schober test		7 days	No
Secondary	Change of Lateral Body Bending test		7 days	No
Secondary	Change of EuroQol by patients		7 days	No
Secondary	Change of Oswestry Disability Index		7 days	No
Secondary	Overall pain improvement by investigator		at last visit (D7+2)	No