Safety, Tolerability and Efficacy of YH14618 in Patients With Degenerative Disc Disease

Study Overview
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Brief Summary
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The objective of this study is to assess the safety and tolerability of YH14618 during 24 weeks of follow-up period after single administration in patients with degenerative disc disease.

Official Title
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A Double-blind, Randomized, Parallel, Placebo Controlled, Phase I/II Clinical Trial to Investigate the Safety, Tolerability and Efficacy of YH14618 Following Single Intradiscal Injection in Patients With Degenerative Disc Disease

Conditions
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Degenerative Disc Disease

Intervention / Treatment
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* Drug: YH14618
* Drug: YH14618
* Drug: YH14618
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Have signed a written informed consent voluntarily, prior to the any procedure Degenerative disc disease patients of aged over 20 years Have one or more of the symptomatic lumbar level(L1 S1) as confirmed using radiology(X-ray, MRI and/or discogram/CT) Have been diagnosed 2 3 degree of MRI index by modified thompson classification Oswestry diability index(ODI) of 30 or greater Visual analog scale(VAS) of 4 or greater Exclusion Criteria: Subjects unable to have radiological examination Have history of neurological disease, herniated lumbar disc, compression fractures and lumbar spinal surgery Sacroiliac joint dysfunction Have been treated with any drugs for pain control within 7 days prior to the first administration Hypersensitivity to drugs Pregnant women, nursing mothers or subjects who do not agree to assigned contraception in the study Participated in any other clinical trials within 30 days prior to the first administration

Ages Eligible for Study
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Minimum Age: 20 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group A<br> | Drug: YH14618<br>* A mg/disc<br>|
| Experimental: Group B<br> | Drug: YH14618<br>* B mg/disc<br>|
| Experimental: Group C<br> | Drug: YH14618<br>* C mg/disc<br>|
| Placebo Comparator: Group D<br> | Drug: Placebo<br>* 0mg/disc<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Evaulate the safety and tolerability after single intradiscal administation | Safety outcomes Adverse events 12-lead EKG Physical examination Standard lab results(hematology, blood chemistry, coagulation, urinalysis etc.) | 12 weeks of observational period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in disc height index at 12 week |  | Baseline, Week 12 | 
| Change from baseline in magnetic resonance imaging(MRI) index |  | Baseline, Week 12 | 
| Change from oswestry diability index(ODI) at week 12 |  | Baseline, Week 12 | 
| Change from baseline in visual analogue scale(VAS) at week 12 |  | Baseline, Week 12 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Degenerative disc disease, YH14618, Penial 2000, Penial 2K