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Clinical Trial of YH14618 in Patients With Degenerative Disc Disease

Primary Purpose

Disc Degenerative Disease

Status

Completed

Phase

Phase 2

Locations

Korea, Republic of

Study Type

Interventional

Intervention

Placebo

YH14618

About this trial

This is an interventional treatment trial for Disc Degenerative Disease

Eligibility Criteria

19 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.)

Sites / Locations

Severance Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Placebo Comparator

Experimental

Arm Label

Placebo group

Group A

Group B

Group C

Group D

Arm Description

Placebo

YH14618 A mg/disc

YH14618 B mg/disc

YH14618 C mg/disc

YH14618 D mg/disc

Outcomes

Primary Outcome Measures

Proportion of VAS responders

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

Secondary Outcome Measures

Proportion of VAS responders

Proportion of mODI responder

Changes in VAS score from baseline

Changes in mODI score from baseline

Full Information

NCT ID

NCT02320019

First Posted

December 11, 2014

Last Updated

November 8, 2016

Sponsor

Yuhan Corporation

1. Study Identification

Unique Protocol Identification Number

NCT02320019

Brief Title

Clinical Trial of YH14618 in Patients With Degenerative Disc Disease

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2016

Overall Recruitment Status

Completed

Study Start Date

March 2015 (undefined)

Primary Completion Date

April 2016 (Actual)

Study Completion Date

August 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Yuhan Corporation

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Disc Degenerative Disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

326 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Placebo group

Arm Type

Placebo Comparator

Arm Description

Placebo

Arm Title

Group A

Arm Type

Experimental

Arm Description

YH14618 A mg/disc

Arm Title

Group B

Arm Type

Experimental

Arm Description

YH14618 B mg/disc

Arm Title

Group C

Arm Type

Experimental

Arm Description

YH14618 C mg/disc

Arm Title

Group D

Arm Type

Experimental

Arm Description

YH14618 D mg/disc

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

Placebo matching YH14618

Intervention Type

Drug

Intervention Name(s)

YH14618

Primary Outcome Measure Information:

Title

Proportion of VAS responders

Description

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

Time Frame

at 12-week

Secondary Outcome Measure Information:

Title

Proportion of VAS responders

Time Frame

at 24-week

Title

Proportion of mODI responder

Time Frame

at 12-week, 24-week

Title

Changes in VAS score from baseline

Time Frame

Each visit for 24 weeks

Title

Changes in mODI score from baseline

Time Frame

Each visit for 24 weeks

Other Pre-specified Outcome Measures:

Title

Proportion of moderate VAS responder

Description

Moderate VAS responder are defined as those who achieve ≥ 30% reduction in VAS from baseline

Time Frame

at 12-week, 24-week

Title

Percent change from baseline to Week 12 and 24 for VAS

Time Frame