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Completed

NCT Number: NCT01526330

Safety, Tolerability and Efficacy of YH14618 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.

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Key information

Conditions

Degenerative Disc Disease Bone Diseases Intervertebral Disc Degeneration Musculoskeletal Diseases Spinal Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Kangbuk Samsung Medical Center

Seoul, 110-746, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

YH14618

Drug

A mg/disc

Placebo

Drug

0mg/disc

Primary outcomes

  1. 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.)

Secondary outcomes

  1. Change from baseline in disc height index at 12 week

    Time frame: Baseline, Week 12

  2. Change from baseline in magnetic resonance imaging(MRI) index

    Time frame: Baseline, Week 12

  3. Change from oswestry diability index(ODI) at week 12

    Time frame: Baseline, Week 12

  4. Change from baseline in visual analogue scale(VAS) at week 12

    Time frame: Baseline, Week 12

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Feb 3, 2012
Registry last updated
May 29, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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