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

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

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.

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