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
1 other identifier
interventional
98
1 country
5
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2 low-back-pain
Started Feb 2013
Shorter than P25 for phase_2 low-back-pain
5 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2013
CompletedFirst Submitted
Initial submission to the registry
March 6, 2013
CompletedFirst Posted
Study publicly available on registry
March 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2013
CompletedAugust 23, 2013
August 1, 2013
5 months
March 6, 2013
August 22, 2013
Conditions
Outcome Measures
Primary Outcomes (1)
VAS improvement of pain at rest, on movement and at night
7 days
Secondary Outcomes (5)
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)
Study Arms (3)
Eperisone 50mg BID
EXPERIMENTALAdministrate Eperisone 50mg tablet after the breakfast and dinner, and pacebo tablet after the lunch for 7 days
Epirisone 50mg TID
EXPERIMENTALPlacebo comparator
PLACEBO COMPARATORInterventions
3 times a day after meals for 1 week
Eligibility Criteria
You may qualify if:
- 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
- ≤ age ≤60
- A patient has symptom of acute low back pain
- ≤ VAS
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (5)
Hallym University Sacred Heart Hospital
Anyang, South Korea
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
Severance Hospital
Seoul, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Hak-Sun Kim, M.D.
Gangnam Severance Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 6, 2013
First Posted
March 7, 2013
Study Start
February 1, 2013
Primary Completion
July 1, 2013
Study Completion
July 1, 2013
Last Updated
August 23, 2013
Record last verified: 2013-08