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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01526330
First Posted: February 3, 2012
Last Update Posted: May 29, 2015
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.
Information provided by (Responsible Party):
Yuhan Corporation
  Purpose
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 Intervention Phase
Degenerative Disc Disease Drug: YH14618 Drug: Placebo Phase 1 Phase 2

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:


Further study details as provided by Yuhan Corporation:

Primary Outcome Measures:
  • 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:
  • Change from baseline in disc height index at 12 week [ Time Frame: Baseline, Week 12 ]
  • Change from baseline in magnetic resonance imaging(MRI) index [ Time Frame: Baseline, Week 12 ]
  • Change from oswestry diability index(ODI) at week 12 [ Time Frame: Baseline, Week 12 ]
  • Change from baseline in visual analogue scale(VAS) at week 12 [ Time Frame: Baseline, Week 12 ]

Enrollment: 48
Study Start Date: May 2012
Study Completion Date: July 2014
Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
0mg/disc

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   20 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT01526330


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

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01526330     History of Changes
Other Study ID Numbers: YH14618-201
First Submitted: January 31, 2012
First Posted: February 3, 2012
Last Update Posted: May 29, 2015
Last Verified: July 2014

Keywords provided by Yuhan Corporation:
Degenerative disc disease
YH14618
Penial 2000
Penial 2K

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