Safety, Tolerability and Efficacy of YH14618 in Patients... | NCT01526330

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

NCT01526330

Sponsor

Yuhan Corporation

Status

Completed

Last Update Posted

May 29, 2015Estimated

Enrollment

48Actual

Phase

Phase 1Phase 2

Conditions

Degenerative Disc Disease

Interventions

YH14618
YH14618
YH14618
Placebo

Countries

South Korea

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2014

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2012

Primary Completion Date

Jan 2014Actual

Completion Date

Jul 2014Actual

First Submitted Date

Jan 31, 2012

First Submission Date that Met QC Criteria

Feb 1, 2012

First Posted Date

Feb 3, 2012Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 27, 2015

Last Update Posted Date

May 29, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Group A	Experimental	Drug: YH14618
Group B	Experimental	Drug: YH14618
Group C	Experimental	Drug: YH14618
Group D	Placebo Comparator	Drug: Placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
YH14618	Drug	A mg/disc	Group A
YH14618

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Measure	Description	Time Frame
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
Change from oswestry diability index(ODI) at week 12

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Young-joon Kwon, MD, PhD.	Kangbuk Samsung Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Kangbuk Samsung Medical Center		Seoul		110-746	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D055959	Intervertebral Disc Degeneration

Ancestor Terms

ID	Term
D013122	Spinal Diseases
D001847	Bone Diseases
D009140	Musculoskeletal Diseases

Browse Leaves

Not provided

Browse Branches

Not provided