Research Hypothesis: There will be a greater proportion of VAS responders defined as those who achieve ≥ 50% reduction from baseline in VAS for low back pain at week 12 following intradiscal injection of YH14618 compared to placebo. Patients have been diagnosed as one or two symptomatic lumbar degenerative disc disease defined as Pfirrmann grade 2 to 4 using MRI. Patients have suffered from persistent low back pain with at least 3 months of conservative therapy and must have low back pain measured by VAS≥4 cm and modified Oswestry disability index (mODI) ≥30% at the baseline.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
326
Severance Hospital
Seoul, South Korea
Proportion of VAS responders
Proportion of VAS responders defined as those who achieve ≥ 50% reduction in VAS at week 12 from baseline
Time frame: at 12-week
Proportion of VAS responders
Time frame: at 24-week
Proportion of mODI responder
Time frame: at 12-week, 24-week
Changes in VAS score from baseline
Time frame: Each visit for 24 weeks
Changes in mODI score from baseline
Time frame: Each visit for 24 weeks
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