NCT02320019

Clinical Trial of YH14618 in Patients With Degenerative Disc Disease

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 326 (actual)
• Sponsor: Yuhan Corporation · Industry
• Sex: All
• Age: 19 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Disc Degenerative Disease

Interventions

Type	Name	Description
DRUG	Placebo	Placebo matching YH14618
DRUG	YH14618

Timeline

• Start date: 2015-03-01
• Primary completion: 2016-04-01
• Completion: 2016-08-01
• First posted: 2014-12-19
• Last updated: 2016-11-10

Locations

1 site across 1 country: South Korea