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: July 14, 2014
Last verified: July 2014
  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
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
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, see Learn About Clinical Studies.

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: July 14, 2014
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 Disc Degeneration
Bone Diseases
Musculoskeletal Diseases

ClinicalTrials.gov processed this record on October 19, 2014