Status:
COMPLETED
Safety, Tolerability and Efficacy of YH14618 in Patients With Degenerative Disc Disease
Lead Sponsor:
Yuhan Corporation
Conditions:
Degenerative Disc Disease
Eligibility:
All Genders
20+ years
Phase:
PHASE1
PHASE2
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.
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2014
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT01526330
Start Date
May 1 2012
End Date
July 1 2014
Last Update
May 29 2015
Active Locations (1)
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1
Kangbuk Samsung Medical Center
Seoul, South Korea, 110-746