Clinical Trial: Clinical Trial of YH14618 in Patients With Degenerative Disc Disease

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official 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

Brief Summary:

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.


Detailed Summary:
Sponsor: Yuhan Corporation

Current Primary Outcome: 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


Original Primary Outcome: Same as current

Current Secondary Outcome:

  • Proportion of VAS responders [ Time Frame: at 24-week ]
  • Proportion of mODI responder [ Time Frame: at 12-week, 24-week ]
  • Changes in VAS score from baseline [ Time Frame: Each visit for 24 weeks ]
  • Changes in mODI score from baseline [ Time Frame: Each visit for 24 weeks ]


Original Secondary Outcome: Same as current

Information By: Yuhan Corporation

Dates:
Date Received: December 11, 2014
Date Started: March 2015
Date Completion:
Last Updated: November 8, 2016
Last Verified: November 2016