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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01526330
Other study ID # YH14618-201
Secondary ID
Status Completed
Phase Phase 1/Phase 2
First received January 31, 2012
Last updated May 27, 2015
Start date May 2012
Est. completion date July 2014

Study information

Verified date July 2014
Source Yuhan Corporation
Contact n/a
Is FDA regulated No
Health authority Korea: Food and Drug Administration
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 48
Est. completion date July 2014
Est. primary completion date January 2014
Accepts healthy volunteers No
Gender Both
Age group 20 Years and older
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
YH14618
A mg/disc
YH14618
B mg/disc
YH14618
C mg/disc
Placebo
0mg/disc

Locations

Country Name City State
Korea, Republic of Kangbuk Samsung Medical Center Seoul

Sponsors (1)

Lead Sponsor Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 Yes
Secondary Change from baseline in disc height index at 12 week Baseline, Week 12 No
Secondary Change from baseline in magnetic resonance imaging(MRI) index Baseline, Week 12 No
Secondary Change from oswestry diability index(ODI) at week 12 Baseline, Week 12 No
Secondary Change from baseline in visual analogue scale(VAS) at week 12 Baseline, Week 12 No
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