Overview

This trial has been completed.

Condition disc degenerative disease
Treatments placebo, yh14618
Phase phase 2
Sponsor Yuhan Corporation
Start date March 2015
End date April 2016
Trial size 326 participants
Trial identifier NCT02320019, YH14618-202

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Placebo Comparator)
Placebo
placebo
Placebo matching YH14618
(Experimental)
YH14618 A mg/disc
yh14618
(Experimental)
YH14618 B mg/disc
yh14618
(Experimental)
YH14618 C mg/disc
yh14618
(Experimental)
YH14618 D mg/disc
yh14618

Primary Outcomes

Measure
Proportion of VAS responders
time frame: at 12-week

Secondary Outcomes

Measure
Proportion of VAS responders
time frame: at 24-week
Proportion of mODI responder
time frame: at 12-week, 24-week
Changes in VAS score from baseline
time frame: Each visit for 24 weeks
Changes in mODI score from baseline
time frame: Each visit for 24 weeks

Eligibility Criteria

Male or female participants at least 19 years old.

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.)

Additional Information

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
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Yuhan Corporation.