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CompletedNCT01526330Updated May 29, 2015

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

A Phase 1/2 interventional study of YH14618 and YH14618 in Degenerative Disc Disease, sponsored by Yuhan Corporation. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2015-05-29.

Sponsored by Yuhan Corporation · Phase 1/2, Interventional, and Treatment

Phase
Phase 1/2
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Degenerative Disc Disease

Keywords

  • Degenerative disc disease
  • YH14618
  • Penial 2000
  • Penial 2K
03

In context

Spinal Diseases

267 studies on the registry are indexed under Spinal Diseases; 54 are open to participants now.

This study's enrollment of 48 is close to the median of 52 across 166 interventional studies indexed under Spinal Diseases.

Browse Spinal Diseases studies →

Lead sponsor

Yuhan Corporation is the lead sponsor of 107 studies on the registry; 6 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
05

Study design

Phase
Phase 1 / Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
48 participants (actual)

Study arms

  • Experimental
    Group A

    Drug: YH14618

  • Experimental
    Group B

    Drug: YH14618

  • Experimental
    Group C

    Drug: YH14618

  • Placebo comparator
    Group D

    Drug: Placebo

Interventions

  • DrugYH14618

    A mg/disc

  • DrugYH14618

    B mg/disc

  • DrugYH14618

    C mg/disc

  • DrugPlacebo

    0mg/disc

06

What researchers measure

Primary outcomes

  1. 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.)

    Time frame: 12 weeks of observational period

Secondary outcomes

  1. Change from baseline in disc height index at 12 week

    Time frame: Baseline, Week 12

  2. Change from baseline in magnetic resonance imaging(MRI) index

    Time frame: Baseline, Week 12

  3. Change from oswestry diability index(ODI) at week 12

    Time frame: Baseline, Week 12

  4. Change from baseline in visual analogue scale(VAS) at week 12

    Time frame: Baseline, Week 12

07

Study locations

1 site
  • Kangbuk Samsung Medical Center
    Seoul, 110-746, Korea, Republic of
08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 29, 2015, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01526330
Lead sponsor
Yuhan Corporation
Responsible party
Sponsor
First posted
Feb 3, 2012
Start date
May 2012
Primary completion
Jan 2014
Completion
Jul 2014
Last update
May 29, 2015

Study contacts

Young-joon Kwon, MD, PhD.
principal investigator · Kangbuk Samsung Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2014. You cannot join it, but the record below documents what was studied.

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