Comparing Efficacy and Safety Between Eperisone a BID and... | NCT01806818

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

NCT01806818

Sponsor

Hanmi Pharmaceutical Company Limited

Status

Completed

Last Update Posted

Aug 23, 2013Estimated

Enrollment

98Actual

Phase

Phase 2

Conditions

Low Back Pain

Interventions

Epirisone 50mg or placebo TID

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2013

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2013

Primary Completion Date

Jul 2013Actual

Completion Date

Jul 2013Actual

First Submitted Date

Mar 6, 2013

First Submission Date that Met QC Criteria

Mar 6, 2013

First Posted Date

Mar 7, 2013Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 22, 2013

Last Update Posted Date

Aug 23, 2013Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

98Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Eperisone 50mg BID	Experimental	Administrate Eperisone 50mg tablet after the breakfast and dinner, and pacebo tablet after the lunch for 7 days	Drug: Epirisone 50mg or placebo TID
Epirisone 50mg TID	Experimental		Drug: Epirisone 50mg or placebo TID
Placebo comparator	Placebo Comparator		Drug: Epirisone 50mg or placebo TID

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Epirisone 50mg or placebo TID	Drug	3 times a day after meals for 1 week	Eperisone 50mg BID Epirisone 50mg TID Placebo comparator

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
VAS improvement of pain at rest, on movement and at night		7 days

Secondary Outcomes

Measure	Description	Time Frame
Change of Modified Schober test		7 days
Change of Lateral Body Bending test		7 days
Change of EuroQol by patients

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

60 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hak-Sun Kim, M.D.	Gangnam Severance Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hallym University Sacred Heart Hospital		Anyang			South Korea
CHA Bundang Medical Center

Condition Browse Module

MeSH Terms

ID	Term
D017116	Low Back Pain

Ancestor Terms

ID	Term
D001416	Back Pain
D010146	Pain
D009461	Neurologic Manifestations
D012816	Signs and Symptoms

Browse Leaves

Not provided

Browse Branches

Not provided