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

Status

Completed

Phases

Phase 1Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01526330

Enrollment

Registered

2012-02-03

Start date

2012-05-31

Completion date

2014-07-31

Last updated

2015-05-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Degenerative Disc Disease

Keywords

Degenerative disc disease, YH14618, Penial 2000, Penial 2K

Brief 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.

Interventions

DRUGYH14618

A mg/disc

DRUGPlacebo

0mg/disc

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

TRIPLE (Subject, Investigator, Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

20 Years to No maximum

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

Design outcomes

Primary

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

Secondary

Measure	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

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026