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

Yuhan

Status and phase: Completed; Phase 2; Phase 1

Conditions: Degenerative Disc Disease

Treatments: Drug: Placebo; Drug: YH14618

Study type: Interventional

Funder types: Industry

Identifiers

NCT01526330

YH14618-201

Details and patient eligibility

About

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.

Enrollment: 48 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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48 participants in 4 patient groups, including a placebo group

Group A

Experimental group

Treatment:

Drug: YH14618

Drug: YH14618

Drug: YH14618

Group B

Experimental group

Treatment:

Drug: YH14618

Drug: YH14618

Drug: YH14618

Group C

Experimental group

Treatment:

Drug: YH14618

Drug: YH14618

Drug: YH14618

Group D

Placebo Comparator group

Treatment:

Drug: Placebo