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

May 27, 2015 updated by: Yuhan Corporation

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

48

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: TRIPLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Group A
Drug: YH14618
A mg/disc
Drug: YH14618
B mg/disc
Drug: YH14618
C mg/disc
EXPERIMENTAL: Group B
Drug: YH14618
A mg/disc
Drug: YH14618
B mg/disc
Drug: YH14618
C mg/disc
EXPERIMENTAL: Group C
Drug: YH14618
A mg/disc
Drug: YH14618
B mg/disc
Drug: YH14618
C mg/disc
PLACEBO_COMPARATOR: Group D
Drug: Placebo
0mg/disc

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Evaulate the safety and tolerability after single intradiscal administation
Time Frame: 12 weeks of observational period

Safety outcomes

  • Adverse events
  • 12-lead EKG
  • Physical examination
  • Standard lab results(hematology, blood chemistry, coagulation, urinalysis etc.)
12 weeks of observational period

Secondary Outcome Measures

Outcome Measure
Time Frame
Change from baseline in disc height index at 12 week
Time Frame: Baseline, Week 12
Baseline, Week 12
Change from baseline in magnetic resonance imaging(MRI) index
Time Frame: Baseline, Week 12
Baseline, Week 12
Change from oswestry diability index(ODI) at week 12
Time Frame: Baseline, Week 12
Baseline, Week 12
Change from baseline in visual analogue scale(VAS) at week 12
Time Frame: Baseline, Week 12
Baseline, Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Yuhan Corporation

Investigators

  • Principal Investigator: Young-joon Kwon, MD, PhD., Kangbuk Samsung Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (ACTUAL)

January 1, 2014

Study Completion (ACTUAL)

July 1, 2014

Study Registration Dates

First Submitted

January 31, 2012

First Submitted That Met QC Criteria

February 1, 2012

First Posted (ESTIMATE)

February 3, 2012

Study Record Updates

Last Update Posted (ESTIMATE)

May 29, 2015

Last Update Submitted That Met QC Criteria

May 27, 2015

Last Verified

July 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • YH14618-201

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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