Clinical Trial: Safety, Tolerability and Efficacy of YH14618 in Patients With Degenerative Disc Disease
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official 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 W
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 Summary:
Sponsor: Yuhan Corporation
Current Primary Outcome: 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.)
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change from baseline in disc height index at 12 week [ Time Frame: Baseline, Week 12 ]
- Change from baseline in magnetic resonance imaging(MRI) index [ Time Frame: Baseline, Week 12 ]
- Change from oswestry diability index(ODI) at week 12 [ Time Frame: Baseline, Week 12 ]
- Change from baseline in visual analogue scale(VAS) at week 12 [ Time Frame: Baseline, Week 12 ]
Original Secondary Outcome: Same as current
Information By: Yuhan Corporation
Dates:
Date Received: January 31, 2012
Date Started: May 2012
Date Completion:
Last Updated: May 27, 2015
Last Verified: July 2014