Clinical Trial of YH14618 in Patients With Degenerative Disc Disease

Phase 2

Completed

• Conditions: Disc Degenerative Disease
• Interventions: Drug: Placebo; Drug: YH14618

• Registration Number: NCT02320019
• Lead Sponsor: Yuhan Corporation

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 Description

Not available

Study Timeline

• Study First Submitted: 2014-12-11
• Study First Submitted QC: 2014-12-18
• Study First Posted: 2014-12-19
• Study Start: 2015-03
• Primary Completion: 2016-04
• Study Completion: 2016-08
• Status Verified: 2016-11
• Last Update Submitted: 2016-11-08
• Last Update Posted: 2016-11-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 326

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.)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo group	Placebo	Placebo
Group A	YH14618	YH14618 A mg/disc
Group C	YH14618	YH14618 C mg/disc
Group D	YH14618	YH14618 D mg/disc
Group B	YH14618	YH14618 B mg/disc

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Changes in mODI score from baseline	Each visit for 24 weeks
Proportion of VAS responders	at 24-week
Proportion of mODI responder	at 12-week, 24-week
Changes in VAS score from baseline	Each visit for 24 weeks

Trial Locations

Locations (1)

Severance Hospital; 🇰🇷 Seoul, Korea, Republic of