Clinical Trial of YH14618 in Patients With Degenerative Disc Disease

Disc Degenerative Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02320019
• Other study ID #: YH14618-202
• Status: Completed
• Phase: Phase 2
• First received: December 11, 2014
• Last updated: November 8, 2016
• Start date: March 2015
• Est. completion date: August 2016

Study information

• Verified date: November 2016
• Source: Yuhan Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Ministry of Food and Drug Safety
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 326
• Est. completion date: August 2016
• Est. primary completion date: April 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Disc Degenerative Disease
• Intervertebral Disc Degeneration

Intervention

Drug:
• Placebo
Placebo matching YH14618
• YH14618

Locations

Country	Name	City	State
Korea, Republic of	Severance Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Yuhan Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Proportion of moderate VAS responder	Moderate VAS responder are defined as those who achieve = 30% reduction in VAS from baseline	at 12-week, 24-week	No
Other	Percent change from baseline to Week 12 and 24 for VAS		Each visit between Week 12 and 24	No
Other	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		Each visit between Week 12 and 24	No
Other	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		Each visit between Week 12 and 24	No
Other	Change in VAS from Week 12 to Week16, 20, and 24		Each visit between Week 12 and 24	No
Other	Change in mODI from Week 12 to Week 16, 20, and 24		Each visit between Week 12 and 24	No
Other	Time to achieve the first = 50% reduction in VAS following the intradiscal injection of Investigational product		For 24 weeks	No
Other	Pfirrmann grade using MRI at Week 24		Screening, Week 24	No
Other	Percent change from baseline to Week 24 for Disc Height Index (DHI)		Screening, Week 24	No
Other	Quality of life measured by EQ-5D and SF-12		at Week 12 and 24	No
Other	Quality of life measured by EQ-5D		at Week 12 and 24	No
Other	Quality of life measured by SF-12		at Week 12 and 24	No
Other	Patient global impression of change		at Week 12 and 24	No
Other	Clinical global impression of change		at Week 12 and 24	No
Other	Time to analgesic rescue following the intradiscal injection of Investigational product		For 24 weeks	No
Other	Amount of rescue medication tablets taken following the intradiscal injection of Investigational product		For 24 weeks	No
Other	The number of days taken rescue medication following the intradiscal injection of investigational product		For 24 weeks	No
Primary	Proportion of VAS responders	Proportion of VAS responders defined as those who achieve = 50% reduction in VAS at week 12 from baseline	at 12-week	No
Secondary	Proportion of VAS responders		at 24-week	No
Secondary	Proportion of mODI responder		at 12-week, 24-week	No
Secondary	Changes in VAS score from baseline		Each visit for 24 weeks	No
Secondary	Changes in mODI score from baseline		Each visit for 24 weeks	No