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

Degenerative Disc Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01526330
• Other study ID #: YH14618-201
• 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

Related Conditions & MeSH terms

• Degenerative Disc Disease
• Intervertebral Disc Degeneration
• Spinal Diseases

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