A Randomized, Double-blind, Active-controlled, Non-inferiority, Multicenter Phase III Study to Evaluate the Efficacy and Safety of HCP1004 as compared to RLD2401 in Chronic Low-Back Pain Patients
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
310
Hanyang University Seoul Hospital
Seoul, Seoul, South Korea
Change from baseline in VAS
Time frame: 4 weeks
Change from baseline in VAS(Visual Analog Scale)
Time frame: 8 weeks, 12 weeks
Change from baseline in ODI(Oswestry Disability Index) Score
Time frame: 4 weeks, 8 weeks, 12 weeks
Change from baseline in EQ-5D Score
Time frame: 4 weeks, 8 weeks, 12 weeks
Change from baseline in GSRS(Gastrointestinal Symptom-Rating Scale) Score
Time frame: 4 weeks, 8 weeks, 12 weeks
Usage of rescue medicine
Time frame: 4 weeks, 8 weeks, 12 weeks
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