Safety, Tolerability and Efficacy of YH14618 in Patients With Degenerative Disc Disease
NCT ID: NCT01526330
Last Updated: 2015-05-29
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
48 participants
INTERVENTIONAL
2012-05-31
2014-07-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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Group A
YH14618
A mg/disc
Group B
YH14618
B mg/disc
Group C
YH14618
C mg/disc
Group D
Placebo
0mg/disc
Interventions
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YH14618
A mg/disc
YH14618
B mg/disc
YH14618
C mg/disc
Placebo
0mg/disc
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
20 Years
ALL
No
Sponsors
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Yuhan Corporation
INDUSTRY
Responsible Party
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Principal Investigators
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Young-joon Kwon, MD, PhD.
Role: PRINCIPAL_INVESTIGATOR
Kangbuk Samsung Hospital
Locations
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Kangbuk Samsung Medical Center
Seoul, , South Korea
Countries
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Other Identifiers
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YH14618-201
Identifier Type: -
Identifier Source: org_study_id
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