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

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

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.

Study Overview

• Status: Completed
• Conditions: Low Back Pain
• Intervention / Treatment: Drug: Epirisone 50mg or placebo TID

• Study Type: Interventional
• Enrollment (Actual): 98
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 60 years (ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: DOUBLE

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: Eperisone 50mg BID; Administrate Eperisone 50mg tablet after the breakfast and dinner, and pacebo tablet after the lunch for 7 days	Drug: Epirisone 50mg or placebo TID; 3 times a day after meals for 1 week
EXPERIMENTAL: Epirisone 50mg TID	Drug: Epirisone 50mg or placebo TID; 3 times a day after meals for 1 week
PLACEBO_COMPARATOR: Placebo comparator	Drug: Epirisone 50mg or placebo TID; 3 times a day after meals for 1 week

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Time Frame
Change of Modified Schober test	7 days
Change of Lateral Body Bending test	7 days
Change of EuroQol by patients	7 days
Change of Oswestry Disability Index	7 days
Overall pain improvement by investigator	at last visit (D7+2)

Collaborators and Investigators

• Sponsor: Hanmi Pharmaceutical Company Limited
• Investigators: Principal Investigator: Hak-Sun Kim, M.D., Gangnam Severance Hospital

Study record dates

Study Major Dates

• Study Start: February 1, 2013
• Primary Completion (ACTUAL): July 1, 2013
• Study Completion (ACTUAL): July 1, 2013

Study Registration Dates

• First Submitted: March 6, 2013
• First Submitted That Met QC Criteria: March 6, 2013
• First Posted (ESTIMATE): March 7, 2013

Study Record Updates

• Last Update Posted (ESTIMATE): August 23, 2013
• Last Update Submitted That Met QC Criteria: August 22, 2013
• Last Verified: August 1, 2013

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Back Pain; Low Back Pain
• Other Study ID Numbers: HM-EPAC-201