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

Primary Purpose

Low Back Pain

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
Epirisone 50mg or placebo TID
Sponsored by
Hanmi Pharmaceutical Company Limited
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Low Back Pain

Eligibility Criteria

20 Years - 60 Years (Adult)All SexesDoes not accept 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

Sites / Locations

  • Hallym University Sacred Heart Hospital
  • CHA Bundang Medical Center
  • Kyung Hee University Hospital
  • Medical college of Yonsei University, Gangnam Severance Hospital
  • Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

Eperisone 50mg BID

Epirisone 50mg TID

Placebo comparator

Arm Description

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

Outcomes

Primary Outcome Measures

VAS improvement of pain at rest, on movement and at night

Secondary Outcome Measures

Change of Modified Schober test
Change of Lateral Body Bending test
Change of EuroQol by patients
Change of Oswestry Disability Index
Overall pain improvement by investigator

Full Information

First Posted
March 6, 2013
Last Updated
August 22, 2013
Sponsor
Hanmi Pharmaceutical Company Limited
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1. Study Identification

Unique Protocol Identification Number
NCT01806818
Brief Title
Comparing Efficacy and Safety Between Eperisone a BID and a TID Regimen in Acute Low Back Pain Patients
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
Study Type
Interventional

2. Study Status

Record Verification Date
August 2013
Overall Recruitment Status
Completed
Study Start Date
February 2013 (undefined)
Primary Completion Date
July 2013 (Actual)
Study Completion Date
July 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Hanmi Pharmaceutical Company Limited

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Low Back Pain

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
98 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eperisone 50mg BID
Arm Type
Experimental
Arm Description
Administrate Eperisone 50mg tablet after the breakfast and dinner, and pacebo tablet after the lunch for 7 days
Arm Title
Epirisone 50mg TID
Arm Type
Experimental
Arm Title
Placebo comparator
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
Epirisone 50mg or placebo TID
Intervention Description
3 times a day after meals for 1 week
Primary Outcome Measure Information:
Title
VAS improvement of pain at rest, on movement and at night
Time Frame
7 days
Secondary Outcome Measure Information:
Title
Change of Modified Schober test
Time Frame
7 days
Title
Change of Lateral Body Bending test
Time Frame
7 days
Title
Change of EuroQol by patients
Time Frame
7 days
Title
Change of Oswestry Disability Index
Time Frame
7 days
Title
Overall pain improvement by investigator
Time Frame
at last visit (D7+2)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hak-Sun Kim, M.D.
Organizational Affiliation
Gangnam Severance Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hallym University Sacred Heart Hospital
City
Anyang
Country
Korea, Republic of
Facility Name
CHA Bundang Medical Center
City
Seoul
Country
Korea, Republic of
Facility Name
Kyung Hee University Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Medical college of Yonsei University, Gangnam Severance Hospital
City
Seoul
Country
Korea, Republic of
Facility Name
Severance Hospital
City
Seoul
Country
Korea, Republic of

12. IPD Sharing Statement

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

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