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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Yuhan Corporation
ClinicalTrials.gov Identifier:
NCT01526330
First received: January 31, 2012
Last updated: December 31, 2013
Last verified: December 2013
  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
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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

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 ] [ Designated as safety issue: Yes ]

    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 ] [ Designated as safety issue: No ]
  • Change from baseline in magnetic resonance imaging(MRI) index [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from oswestry diability index(ODI) at week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]
  • Change from baseline in visual analogue scale(VAS) at week 12 [ Time Frame: Baseline, Week 12 ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: May 2012
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Group A Drug: YH14618
1mg/disc
Experimental: Group B Drug: YH14618
3mg/disc
Experimental: Group C Drug: YH14618
6mg/disc
Placebo Comparator: Group D Drug: Placebo
0mg/disc

  Eligibility

Ages Eligible for Study:   20 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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 Medical center
  More Information

No publications provided

Responsible Party: Yuhan Corporation
ClinicalTrials.gov Identifier: NCT01526330     History of Changes
Other Study ID Numbers: YH14618-201
Study First Received: January 31, 2012
Last Updated: December 31, 2013
Health Authority: Korea: Food and Drug Administration

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

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

ClinicalTrials.gov processed this record on April 16, 2014