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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01526330
Recruitment Status : Completed
First Posted : February 3, 2012
Last Update Posted : May 29, 2015
Information provided by (Responsible Party):
Yuhan Corporation

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.

Condition or disease Intervention/treatment Phase
Degenerative Disc Disease Drug: YH14618 Drug: Placebo Phase 1 Phase 2

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 48 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Study Start Date : May 2012
Actual Primary Completion Date : January 2014
Actual Study Completion Date : July 2014

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Group A Drug: YH14618
A mg/disc

Experimental: Group B Drug: YH14618
B mg/disc

Experimental: Group C Drug: YH14618
C mg/disc

Placebo Comparator: Group D Drug: Placebo

Primary Outcome Measures :
  1. Evaulate the safety and tolerability after single intradiscal administation [ Time Frame: 12 weeks of observational period ]

    Safety outcomes

    • Adverse events
    • 12-lead EKG
    • Physical examination
    • Standard lab results(hematology, blood chemistry, coagulation, urinalysis etc.)

Secondary Outcome Measures :
  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 ]

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01526330

Korea, Republic of
Kangbuk Samsung Medical Center
Seoul, Korea, Republic of, 110-746
Sponsors and Collaborators
Yuhan Corporation
Principal Investigator: Young-joon Kwon, MD, PhD. Kangbuk Samsung Hospital

Responsible Party: Yuhan Corporation Identifier: NCT01526330     History of Changes
Other Study ID Numbers: YH14618-201
First Posted: February 3, 2012    Key Record Dates
Last Update Posted: May 29, 2015
Last Verified: July 2014

Keywords provided by Yuhan Corporation:
Degenerative disc disease
Penial 2000
Penial 2K

Additional relevant MeSH terms:
Spinal Diseases
Intervertebral Disc Degeneration
Bone Diseases
Musculoskeletal Diseases