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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo group | Placebo Comparator | Placebo |
|
| Group A | Experimental | YH14618 A mg/disc |
|
| Group B | Experimental | YH14618 B mg/disc |
|
| Group C | Experimental | YH14618 C mg/disc |
|
| Group D | Experimental | YH14618 D mg/disc |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Placebo | Drug | Placebo matching YH14618 |
| |
| YH14618 |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of VAS responders | Proportion of VAS responders defined as those who achieve ≥ 50% reduction in VAS at week 12 from baseline | at 12-week |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of VAS responders | at 24-week | |
| Proportion of mODI responder | at 12-week, 24-week | |
| Changes in VAS score from baseline |
| Measure | Description | Time Frame |
|---|---|---|
| Proportion of moderate VAS responder | Moderate VAS responder are defined as those who achieve ≥ 30% reduction in VAS from baseline | at 12-week, 24-week |
| Percent change from baseline to Week 12 and 24 for VAS |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Su Youn Nam, M.D., Ph.D. | Yuhan Corporation | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Severance Hospital | Seoul | South Korea |
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| ID | Term |
|---|---|
| D055959 | Intervertebral Disc Degeneration |
| ID | Term |
|---|---|
| D013122 | Spinal Diseases |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
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| Drug |
|
| Each visit for 24 weeks |
| Changes in mODI score from baseline | Each visit for 24 weeks |
| Each visit between Week 12 and 24 |
| Proportion of patients who are being VAS responders at Week 12 and maintain the treatment effect of ≥ 50% reduction in VAS up to week 16, 20, and 24 | Each visit between Week 12 and 24 |
| Proportion of patients who are being mODI responders at Week 12 and maintain the treatment effect of ≥ 15 points reduction in mODI up to week 16, 20, and 24 | Each visit between Week 12 and 24 |
| Change in VAS from Week 12 to Week16, 20, and 24 | Each visit between Week 12 and 24 |
| Change in mODI from Week 12 to Week 16, 20, and 24 | Each visit between Week 12 and 24 |
| Time to achieve the first ≥ 50% reduction in VAS following the intradiscal injection of Investigational product | For 24 weeks |
| Pfirrmann grade using MRI at Week 24 | Screening, Week 24 |
| Percent change from baseline to Week 24 for Disc Height Index (DHI) | Screening, Week 24 |
| Quality of life measured by EQ-5D and SF-12 | at Week 12 and 24 |
| Quality of life measured by EQ-5D | at Week 12 and 24 |
| Quality of life measured by SF-12 | at Week 12 and 24 |
| Patient global impression of change | at Week 12 and 24 |
| Clinical global impression of change | at Week 12 and 24 |
| Time to analgesic rescue following the intradiscal injection of Investigational product | For 24 weeks |
| Amount of rescue medication tablets taken following the intradiscal injection of Investigational product | For 24 weeks |
| The number of days taken rescue medication following the intradiscal injection of investigational product | For 24 weeks |