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OpenTrials
Completed

NCT Number: NCT02320019

Clinical Trial of YH14618 in Patients With Degenerative Disc Disease

Research Hypothesis:

There will be a greater proportion of VAS responders defined as those who achieve ≥ 50% reduction from baseline in VAS for low back pain at week 12 following intradiscal injection of YH14618 compared to placebo. Patients have been diagnosed as one or two symptomatic lumbar degenerative disc disease defined as Pfirrmann grade 2 to 4 using MRI. Patients have suffered from persistent low back pain with at least 3 months of conservative therapy and must have low back pain measured by VAS≥4 cm and modified Oswestry disability index (mODI) ≥30% at the baseline.

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Key information

Conditions

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

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Severance Hospital

Seoul, South Korea

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Patients diagnosed as one or two symptomatic early lumbar (L1/L2 ~ L5/S1) degenerative disc disease defined as Pfirrmann grade 2 to 4 using MRI performed within 4 weeks prior to randomization.
  • Patients have suffered from persistent low back pain with at least 3-month conservative therapy.
  • Patients have low back pain measured by VAS≥4cm and mODI≥30% at screening and randomization visit (Day 0).

Exclusion criteria

  • Clinically significant spine compression fracture, spinal stenosis, or spinal instability.
  • Clinically significant sacroiliac joint dysfunction, facet joint pain, or those who are suspected.
  • Modic change type III assessed by X-ray and MRI
  • History of spine surgery
  • Neurologic disorders.
  • Any other systemic disease which can influence spine such as rheumatoid arthritis, ankylosing spondylitis, or autoimmune disease.
  • Participation in other clinical trials with intradiscal injection (eg, Phase 1/2a YH14618-201 trial, or Cell therapy, etc.)

Treatment and study plan

Placebo

Drug

Placebo matching YH14618

YH14618

Drug

Primary outcomes

  1. Proportion of VAS responders

    Time frame: at 12-week

    Proportion of VAS responders defined as those who achieve ≥ 50% reduction in VAS at week 12 from baseline

Secondary outcomes

  1. Proportion of VAS responders

    Time frame: at 24-week

  2. Proportion of mODI responder

    Time frame: at 12-week, 24-week

  3. Changes in VAS score from baseline

    Time frame: Each visit for 24 weeks

  4. Changes in mODI score from baseline

    Time frame: Each visit for 24 weeks

Other outcomes

  1. Proportion of moderate VAS responder

    Time frame: at 12-week, 24-week

    Moderate VAS responder are defined as those who achieve ≥ 30% reduction in VAS from baseline

  2. Percent change from baseline to Week 12 and 24 for VAS

    Time frame: Each visit between Week 12 and 24

  3. Proportion of patients who are being VAS responders at Week 12 and maintain the treatment effect of ≥ 50% reduction in VAS up to week 16, 20, and 24

    Time frame: Each visit between Week 12 and 24

  4. Proportion of patients who are being mODI responders at Week 12 and maintain the treatment effect of ≥ 15 points reduction in mODI up to week 16, 20, and 24

    Time frame: Each visit between Week 12 and 24

  5. Change in VAS from Week 12 to Week16, 20, and 24

    Time frame: Each visit between Week 12 and 24

  6. Change in mODI from Week 12 to Week 16, 20, and 24

    Time frame: Each visit between Week 12 and 24

  7. Time to achieve the first ≥ 50% reduction in VAS following the intradiscal injection of Investigational product

    Time frame: For 24 weeks

  8. Pfirrmann grade using MRI at Week 24

    Time frame: Screening, Week 24

  9. Percent change from baseline to Week 24 for Disc Height Index (DHI)

    Time frame: Screening, Week 24

  10. Quality of life measured by EQ-5D and SF-12

    Time frame: at Week 12 and 24

  11. Quality of life measured by EQ-5D

    Time frame: at Week 12 and 24

  12. Quality of life measured by SF-12

    Time frame: at Week 12 and 24

  13. Patient global impression of change

    Time frame: at Week 12 and 24

  14. Clinical global impression of change

    Time frame: at Week 12 and 24

  15. Time to analgesic rescue following the intradiscal injection of Investigational product

    Time frame: For 24 weeks

  16. Amount of rescue medication tablets taken following the intradiscal injection of Investigational product

    Time frame: For 24 weeks

  17. The number of days taken rescue medication following the intradiscal injection of investigational product

    Time frame: For 24 weeks

Sponsors and collaborators

Lead sponsor

Yuhan Corporation

Industry

Registry information

Official study title

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 2b Trial to Evaluate the Efficacy and Safety of YH14618 in Patients With Lumbar Degenerative Disc Disease

Important dates

Study start
2015
Primary completion
2016
Study completion
2016
First posted
Dec 19, 2014
Registry last updated
Nov 10, 2016

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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