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

• Status: Completed
• Trial end date: 2014-07-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Yuhan Corporation

Criteria

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