Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Epirisone 50mg or placebo TID

+ Epirisone 50mg or placebo TID

+ Epirisone 50mg or placebo TID

Drug
Who is being recruted

Back Pain+3

+ Neurologic Manifestations

+ Pain

From 20 to 60 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Placebo-ControlledPhase 2
Interventional
Study Start: February 2013
See protocol details

Summary

Principal SponsorHanmi Pharmaceutical Company Limited
Last updated: August 23, 2013
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2013

Actual date on which the first participant was enrolled.

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.

NCT01806818
Principal SponsorHanmi Pharmaceutical Company Limited
Last updated: August 23, 2013
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

98 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.

Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 20 to 60 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Back PainNeurologic ManifestationsPainSigns and SymptomsPathological Conditions, Signs and SymptomsLow Back Pain

Criteria

4 inclusion criteria required to participate
20 <= age <= 60
4 <= VAS
A patient has symptom of acute low back pain
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
7 exclusion criteria prevent from participating
Chronic rheumatoid arthritis patients
Female patients having positive pregnancy test, lactating women,planning pregnancy during clinical trial
Inadequate subject for the clinical trial by the investigator's decision
Participation in other studies before 60 days of first dosing
Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

3 intervention groups are designated in this study

33.333% chance of being blinded to the placebo group

Treatment Groups

Group I

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

Group II

Experimental

Group III

Placebo

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 5 locations

Hallym University Sacred Heart Hospital

Anyang, South KoreaOpen Hallym University Sacred Heart Hospital in Google Maps

CHA Bundang Medical Center

Seoul, South Korea

Kyung Hee University Hospital

Seoul, South Korea

Medical college of Yonsei University, Gangnam Severance Hospital

Seoul, South Korea
Completed5 Study Centers