Clinical trial NCT02320019: 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
Overall status: COMPLETED
Phase: PHASE2
Conditions: Disc Degenerative Disease
Lead sponsor: Yuhan Corporation
Sponsor class: INDUSTRY
First posted: 2014-12-19
Enrollment: 326
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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.)

Primary outcomes:
measure: Proportion of VAS responders
timeFrame: at 12-week
Secondary outcomes:
measure: Proportion of VAS responders
timeFrame: at 24-week
measure: Proportion of mODI responder
timeFrame: at 12-week, 24-week
measure: Changes in VAS score from baseline
timeFrame: Each visit for 24 weeks
measure: Changes in mODI score from baseline
timeFrame: Each visit for 24 weeks
Other outcomes:
measure: Proportion of moderate VAS responder
timeFrame: at 12-week, 24-week
measure: Percent change from baseline to Week 12 and 24 for VAS
timeFrame: Each visit between Week 12 and 24
measure: 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
timeFrame: Each visit between Week 12 and 24
measure: 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
timeFrame: Each visit between Week 12 and 24
measure: Change in VAS from Week 12 to Week16, 20, and 24
timeFrame: Each visit between Week 12 and 24
measure: Change in mODI from Week 12 to Week 16, 20, and 24
timeFrame: Each visit between Week 12 and 24
measure: Time to achieve the first ≥ 50% reduction in VAS following the intradiscal injection of Investigational product
timeFrame: For 24 weeks
measure: Pfirrmann grade using MRI at Week 24
timeFrame: Screening, Week 24
measure: Percent change from baseline to Week 24 for Disc Height Index (DHI)
timeFrame: Screening, Week 24
measure: Quality of life measured by EQ-5D and SF-12
timeFrame: at Week 12 and 24
measure: Quality of life measured by EQ-5D
timeFrame: at Week 12 and 24
measure: Quality of life measured by SF-12
timeFrame: at Week 12 and 24
measure: Patient global impression of change
timeFrame: at Week 12 and 24
measure: Clinical global impression of change
timeFrame: at Week 12 and 24
measure: Time to analgesic rescue following the intradiscal injection of Investigational product
timeFrame: For 24 weeks
measure: Amount of rescue medication tablets taken following the intradiscal injection of Investigational product
timeFrame: For 24 weeks
measure: The number of days taken rescue medication following the intradiscal injection of investigational product
timeFrame: For 24 weeks
Locations:
city: Seoul
country: Korea, Republic of
facility: Severance Hospital
Study officials:
affiliation: Yuhan Corporation
name: Su Youn Nam, M.D., Ph.D.
role: STUDY_DIRECTOR
References: