Safety, Tolerability and Efficacy of YH14618 in Patients With Degenerative Disc Disease
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
1 other identifier
interventional
48
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started May 2012
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 31, 2012
CompletedFirst Posted
Study publicly available on registry
February 3, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
July 1, 2014
CompletedMay 29, 2015
July 1, 2014
1.7 years
January 31, 2012
May 27, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.)
12 weeks of observational period
Secondary Outcomes (4)
Change from baseline in disc height index at 12 week
Baseline, Week 12
Change from baseline in magnetic resonance imaging(MRI) index
Baseline, Week 12
Change from oswestry diability index(ODI) at week 12
Baseline, Week 12
Change from baseline in visual analogue scale(VAS) at week 12
Baseline, Week 12
Study Arms (4)
Group A
EXPERIMENTALGroup B
EXPERIMENTALGroup C
EXPERIMENTALGroup D
PLACEBO COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Kangbuk Samsung Medical Center
Seoul, 110-746, South Korea
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Young-joon Kwon, MD, PhD.
Kangbuk Samsung Hospital
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 31, 2012
First Posted
February 3, 2012
Study Start
May 1, 2012
Primary Completion
January 1, 2014
Study Completion
July 1, 2014
Last Updated
May 29, 2015
Record last verified: 2014-07