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

Phase 1

Completed

• Conditions: Degenerative Disc Disease
• Interventions: Drug: Placebo; Drug: YH14618

• Registration Number: NCT01526330
• Lead Sponsor: Yuhan Corporation

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2012-01-31
• Study First Submitted QC: 2012-02-01
• Study First Posted: 2012-02-03
• Study Start: 2012-05
• Primary Completion: 2014-01
• Status Verified: 2014-07
• Study Completion: 2014-07
• Last Update Submitted: 2015-05-27
• Last Update Posted: 2015-05-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group D	Placebo	-
Group B	YH14618	-
Group A	YH14618	-
Group C	YH14618	-

Primary Outcome Measures

Name	Time	Method
Evaulate the safety and tolerability after single intradiscal administation	12 weeks of observational period	Safety outcomes; * Adverse events; * 12-lead EKG; * Physical examination; * Standard lab results(hematology, blood chemistry, coagulation, urinalysis etc.)

Secondary Outcome Measures

Name	Time	Method
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
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

Trial Locations

Locations (1)

Kangbuk Samsung Medical Center; 🇰🇷 Seoul, Korea, Republic of