search
Back to results

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

Primary Purpose

Degenerative Disc Disease

Status
Completed
Phase
Phase 1
Locations
Korea, Republic of
Study Type
Interventional
Intervention
YH14618
YH14618
YH14618
Placebo
Sponsored by
Yuhan Corporation
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Degenerative Disc Disease focused on measuring Degenerative disc disease, YH14618, Penial 2000, Penial 2K

Eligibility Criteria

20 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Kangbuk Samsung Medical Center

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Group A

Group B

Group C

Group D

Arm Description

Outcomes

Primary Outcome Measures

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.)

Secondary Outcome Measures

Change from baseline in disc height index at 12 week
Change from baseline in magnetic resonance imaging(MRI) index
Change from oswestry diability index(ODI) at week 12
Change from baseline in visual analogue scale(VAS) at week 12

Full Information

First Posted
January 31, 2012
Last Updated
May 27, 2015
Sponsor
Yuhan Corporation
search

1. Study Identification

Unique Protocol Identification Number
NCT01526330
Brief Title
Safety, Tolerability and Efficacy of YH14618 in Patients With Degenerative Disc Disease
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 Type
Interventional

2. Study Status

Record Verification Date
July 2014
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
January 2014 (Actual)
Study Completion Date
July 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yuhan Corporation

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Degenerative Disc Disease
Keywords
Degenerative disc disease, YH14618, Penial 2000, Penial 2K

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group A
Arm Type
Experimental
Arm Title
Group B
Arm Type
Experimental
Arm Title
Group C
Arm Type
Experimental
Arm Title
Group D
Arm Type
Placebo Comparator
Intervention Type
Drug
Intervention Name(s)
YH14618
Intervention Description
A mg/disc
Intervention Type
Drug
Intervention Name(s)
YH14618
Intervention Description
B mg/disc
Intervention Type
Drug
Intervention Name(s)
YH14618
Intervention Description
C mg/disc
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
0mg/disc
Primary Outcome Measure Information:
Title
Evaulate the safety and tolerability after single intradiscal administation
Description
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 Outcome Measure Information:
Title
Change from baseline in disc height index at 12 week
Time Frame
Baseline, Week 12
Title
Change from baseline in magnetic resonance imaging(MRI) index
Time Frame
Baseline, Week 12
Title
Change from oswestry diability index(ODI) at week 12
Time Frame
Baseline, Week 12
Title
Change from baseline in visual analogue scale(VAS) at week 12
Time Frame
Baseline, Week 12

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Young-joon Kwon, MD, PhD.
Organizational Affiliation
Kangbuk Samsung Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Kangbuk Samsung Medical Center
City
Seoul
ZIP/Postal Code
110-746
Country
Korea, Republic of

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs